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Tests Waived by FDA from January 2000 to Present

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Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a test system name, you can view the CLIA data for that test system, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of categorization of the test, then by test system name. This list does not include test systems that were characterized by the CDC prior to January 2000.

Document Test System Name
Analyte		 Analyte Specialty Effective Date
IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System  
K080283 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Basic Blood Glucose Monitoring System  
K072854 Glucose General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Superb Blood Glucose Monitoring System  
K072854 Glucose General Chemistry 06/30/2008
Tyson Bioresearch Inc. Diachex Vigor Blood Glucose Monitoring System  
K072854 Glucose General Chemistry 06/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Germaine Laboratories AimStrip Pregnancy  
K974368 Urine hCG By Visual Color Comparison Tests Endocrinology 06/26/2008
AZO Test Strips Urinary Tract Infection Test  
K063295 Nitrite, Urine General Chemistry 06/25/2008
AZO Test Strips Urinary Tract Infection Test  
K063295 Leukocyte Esterase, Urinary Urinalysis 06/25/2008
Clever Chek Auto-Code Voice Blood Glucose Monitoring System  
K081144 Glucose General Chemistry 06/23/2008
HemoCue Albumin 201 System  
K053253 Albumin, Urinary General Chemistry 06/13/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
SpermCheck Vasectomy  
K073039 Semen Hematology 06/12/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Ketone Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Bilirubin Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Blood Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Glucose Urinalysis 05/28/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Nitrite Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick pH Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Protein Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Urobilinogen Urinalysis 05/28/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Specific Gravity Urinalysis 05/28/2008
Henery Schein OneStepPlus Urine Analyzer  
K061742 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 05/28/2008
Specialty Medical Supplies SureChek Edge Blood Glucose Monitoring System  
K080501 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology ACHTUNG TD-4207 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4209 One-Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TaiDoc Technology CLEVER CHEK TD-4222 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4225 No Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Taidoc Technology CLEVER CHEK TD-4226 One-Code Blood Glucose Monitoring System  
K073494 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/28/2008
Diagnostic Test Group Clarity Ketone Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 05/19/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 05/19/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 05/19/2008
Home Diagnostics, Preferred Plus Pharmacy TRUEread Blood Glucose Monitoring System  
K042080 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/29/2008
AgaMatrix WaveSense KeyNote Pro Blood Glucose Monitoring System  
K052762 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
AgaMatrix WaveSense Presto Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
Target Corporation, EasyPRO Plus Blood Glucose Monitoring System  
K063068 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/24/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Apex Biotechnology Corp. GlucoSure Voice Blood Glucose Monitoring System  
K073137 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
LifeScan One Touch UltraLink Blood Glucose Monitoring System  
K073231 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
Neuero Engineering Inc. 3test Supreme Glucose Monitoring System  
K072905 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K942782 Glucose General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782 Albumin General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782 Protein, Total General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K942782 Bilirubin, Total General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagenr Disc} (Whole Blood)
K942782 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K950164 Alkaline Phosphatase (ALP) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K950164 Amylase General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Pluse Reagent Disc} (Whole Blood)
K950164 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Liver Panel Plus} (Whole Blood)
K955770 Gamma Glutamyl Transferase (GGT) General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023639 Triglyceride General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023639 Triglyceride General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer {Lipid Panel Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Apex Biotechnology Corp. GlucoSure Star Blood Glucose Monitoring System  
K073648 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640 HDL Cholesterol General Chemistry 04/14/2008
Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023642 Cholesterol General Chemistry 04/14/2008
Piccolo Point of Care Chemistry Analyzer {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023639 Triglyceride General Chemistry 04/14/2008
Tyson Bioresearch Inc. Diachex+ Determine Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Tyson Bioresearch, Inc., Diachex+ Infinity Blood Glucose Monitoring System  
K073492 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/14/2008
Diagnostic Test Group Clarity Strep A Rapid Test Strips  
K983386 Streptococcus, Group A Bacteriology 04/08/2008
Bayer A1CNow +  (For professional use)
K051321 Glycated Hemoglobin, Total General Chemistry 03/31/2008
Fora Care Inc. Fora Comfort 2 in 1 Blood Glucose Plus Blood Pressure Monitoring System TD-3250  
K062800 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
HMD Biomedical Llc Evolution Blood Glucose Monitoring System  
K072369 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Professional Diagnostics BioStar Acceava hCG Urine II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 03/26/2008
Tyson Bioresearch, Inc. EZ Scan Plus Blood Glucose Monitoring System  
K072441 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/26/2008
Inverness Medical BioStar Acceava Strep A Twist {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
Jant Pharmacal Accutest Integrated Strep A Rapid Test Device {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
Moore Medical The Supply Experts Strep A Test - Cassette {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
AmeriTek dBest One Step Occult Blood Test  
K071242 Fecal Occult Blood General Chemistry 03/12/2008
Diagnostic Devices Prodigy Voice Blood Glucose Monitoring System  
K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2008
Diagnostic Test Group, Clarity Blood Glucose Monitoring System  
K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2008
Bestgen Major III Blood Glucose Monitoring System  
K072274 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/04/2008
Henry Schein One Step + Strep A Cassette Test  
K023766 Streptococcus, Group A Bacteriology 03/04/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
TaiDoc Clever Chek TD-4232 Blood Glucose Monitoring System  
K073119 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/04/2008
Qualigen, Inc. FastChek TSH  (Whole Blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 02/29/2008
Nova Biomedical Corp. StatStrip Glucose Hospital Meter  
K060345 Glucose Monitoring Devices (Prescription Use Only) General Chemistry 02/28/2008
Nova Biomedical, Nova Max Link Blood Glucose Monitoring System  
K040603 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/28/2008
Henry Schein One Step + Mononucleosis Rapid Test Device  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/26/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quidel QuickVue RSV Test  
K061008 Respiratory Syncytial Virus Virology 02/25/2008
Quidel QuickVue RSV Test  
K070747 Respiratory Syncytial Virus Virology 02/25/2008
Clarity MONO Mononucleosis Rapid Test  (Whole Blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 02/13/2008
AgaMatrix WaveSense KeyNote Codeless Blood Glucose Monitoring System  
K073573 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/31/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Amphetamines Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methadone Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methamphetamines Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Benzodiazepines Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Barbiturates Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Morphine Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Tricyclic Antidepressants Toxicology / TDM 01/30/2008
BTNX Inc. Know Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Amphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cannabinoids (THC) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Phencyclidine (PCP) Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Cocaine Metabolites Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methadone Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methamphetamines Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Benzodiazepines Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Barbiturates Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Morphine Toxicology / TDM 01/30/2008
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Tricyclic Antidepressants Toxicology / TDM 01/30/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
BTNX Inc. Rapid Response Multi-Drug One Step Screen Test Panel (Urine)  
K063545 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/30/2008
JANT Pharmacal Corporation Accutest Value + Urine Pregnancy Test Device  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 01/30/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Amphetamines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Cannabinoids (THC) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Phencyclidine (PCP) Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Cocaine Metabolites Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Benzodiazepines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)  
K070009 Barbiturates Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Opiates Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Methadone Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Methamphetamines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308T)   
K070009 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Amphetamines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Cannabinoids (THC) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Phencyclidine (PCP) Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Cocaine Metabolites Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Opiates Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Methadone Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Methamphetamines Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Benzodiazepines Toxicology / TDM 01/23/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Barbiturates Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 9308Z)  
K070009 Oxycodone Toxicology / TDM 01/23/2008
Phamatech At Home 12 Drug Test (Model 930T)   
K070009 Oxycodone Toxicology / TDM 01/23/2008
Becton Dickinson BD Chek Group A Strep Test  
K010582 Streptococcus, Group A Bacteriology 01/22/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity H. pylori Rapid Test Device  (Whole Blood)
K980798 Helicobacter Pylori Antibodies General Immunology 01/22/2008
BTNX Inc. Rapid Response H. pylori Whole Blood Rapid Test Device  
K024360 Helicobacter Pylori Antibodies General Immunology 01/15/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Amphetamines Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Cannabinoids (THC) Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Phencyclidine (PCP) Toxicology / TDM 01/08/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Cocaine Metabolites Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Opiates Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Propoxyphene Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Benzodiazepines Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Barbiturates Toxicology / TDM 01/08/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Tricyclic Antidepressants Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 01/08/2008
Abbott Diagnostics Signify ER Drug Screen Test   
K041685 Oxycodone Toxicology / TDM 01/08/2008
Accutech CholesTrak HDL Cholesterol Home Test  
K072836 HDL Cholesterol General Chemistry 01/08/2008
Diagnostic Devices, Inc. Prodigy Autocode Blood Glucose Monitoring System  
K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Jant Pharmacal Accutest Value + Mononucleosis Rapid Test  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008
Stanbio Rely Mono Rapid Test  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/08/2008
TaiDoc Technology Corporation Clever Chek TD-4227 Blood Glucose Monitoring System  
K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {cassette} (professional use)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {midstream} (professional)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test {strip} (professional)
K071930 hCG, Urine Endocrinology 12/19/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Amphetamines Toxicology / TDM 12/13/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Cannabinoids (THC) Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Phencyclidine (PCP) Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Cocaine Metabolites Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Opiates Toxicology / TDM 12/13/2007
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Methamphetamines Toxicology / TDM 12/13/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Quest Diagnostics Incorporated, Express Results Integrated Multi-Drug Screen Cup  (professional use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/13/2007
EPS Bio Technology EasyPlus mini Self Monitoring Blood Glucose System  
K070053 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007
Gluco Perfect L.L.C., Gluco Perfect 2 Blood Glucose Monitoring System  
K062799 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/06/2007
Jant Pharmacal Accutest Value + H. pylori Rapid Test Device  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 11/26/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Ketone Urinalysis 11/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Glucose Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Nitrite Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Blood Urinalysis 11/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick pH Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Protein Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/16/2007
JANT Pharmacal Corporation Accutest Value + Urine/Serum Pregnancy Test Device   
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 11/16/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Vertex Diagnostics UltraTRAK Blood Glucose Monitoring System  
K062235 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/16/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Ketone Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Bilirubin Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Blood Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Glucose Urinalysis 11/08/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Leukocytes Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick pH Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Protein Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax  
K061742 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/08/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Macherey-Nagel URYXXON Relax   
K061742 Urine Qualitative Dipstick Nitrite Urinalysis 11/08/2007
Macherey-Nagel URYXXON Relax   
K061742 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/08/2007
BinaxNOW Influenza A & B Test  (Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens and Nasal Swabs (NS))
K062109 Influenza A/B Virology 11/01/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Albumin General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Protein, Total General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Creatinine General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Alkaline Phosphatase (ALP) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Bilirubin, Total General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Creatinine General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis Piccolo Blood Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Protein, Total General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Creatinine General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Calcium, Total General Chemistry 10/30/2007
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Creatinine General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Urea (BUN) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc,} (Whole Blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140 potassium General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Reagent Disc} (Whole Blood)
K992140 Carbon Dioxide, Total (CO2) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc,} (Whole Blood)
K992140 potassium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Albumin General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Alanine Aminotransferase (ALT) (SGPT) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Aspartate Aminotransferase (AST) (SGOT) General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Alkaline Phosphatase (ALP) General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K993211 Bilirubin, Total General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Glucose General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K993211 Sodium General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Comprehensive Metabolic Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Basic Metabolic Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 10/30/2007
Abaxis, Piccolo xpress Chemistry Analyzer {Electrolyte Metabolic Reagent Disc} (Whole Blood)
K010670 chloride General Chemistry 10/30/2007
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Gluco Perfect, L.L.C. Gluco Perfect Blood Glucose Monitoring System  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/30/2007