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CLIA - 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.
 
 
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Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Lil' Drug Store Products Inc. Vagi-Screen Vaginal Health Test  
X080117 pH General Chemistry 03/16/2009
lifeSign Status-COLON ASSURE Guaiac Test  
K902360 Fecal Occult Blood General Chemistry 03/05/2009
LifeScan OneTouch Vita Blood Glucose Monitoring System  
K082513 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
LifeScan One Touch UltraLink Blood Glucose Monitoring System  
K073231 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/18/2008
Lifescan, Inc. OneTouch Select Meter  
K072543 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/11/2007
Lightstar Enterprises, Inc. GlucoTest Excel Blood Glucose Monitoring System  
K043512 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/16/2007
LifeSign, LLC Status hCG Strip  
K950307 Urine hCG By Visual Color Comparison Tests Endocrinology 01/09/2007
LifeSign Status Mono  (For whole blood)
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 11/22/2006
Little Nell Labs ThyroChek TSH   (Whole Blood)
K990658 Thyroid Stimulating Hormone (TSH) Endocrinology 10/04/2006
LifeScan OneTouch UltraMini Blood Glucose Monitoring System  
K061118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/22/2006
Lifescan One Touch Ultra 2 Blood Glucose Monitoring System  
K053529 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/22/2006
Leader Sidekick Blood Glucose Test System  (Over-The-Counter)
K051147 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2005
LifesScan OneTouch InDuo Blood Glucose Monitoring System  
K043197 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
LifesScan OneTouch Ultra Blood Glucose Monitoring System  
K043197 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
LifesScan OneTouch UltrasSmart Blood Glucose Monitoring System  
K043197 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/03/2005
Longs Drugs Glucose Monitor TrueTrack Smart System, Blood Glucose Monitoring System  
K032657 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/30/2005
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A CASSETTE TEST  
K023766 Streptococcus, Group A Bacteriology 10/29/2004
LABORATORY SUPPLY COMPANY (LSC) PEP STREP A DIPSTICK TEST  
K010582 Streptococcus, Group A Bacteriology 10/29/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG COMBO TEST  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 09/20/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG STRIP TEST  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 09/20/2004
LABORATORY SUPPLY COMPANY (LSC) PEP HCG TEST  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 09/20/2004
LIFESTREAM TECHNOLOGIES LIFESTREAM PLUS CHOLESTEROL MONITOR  
K033899 Cholesterol General Chemistry 06/02/2004
Longs Drugs Truetrack Smart System, Blood Glucose Monitoring System  
K030703 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/22/2003
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K024194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
LIFESCAN ONETOUCH IN DUO BLOOD GLUCOSE MONITORING SYSTEM  
K024194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/10/2003
LIFESCAN SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM  
K023832 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2002
LIFESCAN HARMONY INR MONITORING SYSTEM  (Professional Use)
K022922 Prothrombin Time (PT) Hematology 11/21/2002
LIFESCAN HARMONY INR MONITORY SYSTEM  (Prescription Home Use)
K022922 Prothrombin Time (PT) Hematology 11/21/2002
LIFESCAN SURESTEP FLEXX BLOOD GLUCOSE MONITORING SYSTEM  
K023194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
LIFESCAN SURESTEP PRO  
K023194 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/01/2002
LIFESCAN ONETOUCH SURESTEP BLOOD GLUCOSE MONITORING SYSTEM  
K022724 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/09/2002
LIFESCAN ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM  
K021819 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/29/2002
LUNA FERTILITY INDICATOR  
K020953 Fern Test, Saliva Endocrinology 08/26/2002
LIFESCAN FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM  
K011479 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K011479 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/17/2001
LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (Professional Use)
K001699 Prothrombin Time (PT) Hematology 08/06/2001
LIFESCAN RUBICON PROTHROMBIN TIME MONITORING SYSTEM  (Prescription Home Use)
K001699 Prothrombin Time (PT) Hematology 08/06/2001
LIFESCAN SURESTEP PRO  
K970556 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/25/2001
LIFESCAN SATURN BLOOD GLUCOSE MONITORING TEST STRIP  
K001441 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/19/2000
LIFE MEDICAL BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 11/29/2000
LIFESCAN SURESTEP FLEXX BLOOD GLUCOSE MONITORING SYSTEM  
K970556 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/18/2000
LIFESCAN ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM  
K002134 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2000
LIFESCAN ONE TOUCH IIB BLOOD GLUCOSE METER {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP} 
K001092 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/01/2000
LIFESCAN ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM {INBIOS INTERNATIONAL, INC. GENERIC BLOOD GLUCOSE TEST STRIP} 
K001092 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/01/2000
LIFESTREAM TECHNOLOGIES PERSONAL CHOLESTEROL MONITOR  (For OTC use)
K000610 Cholesterol General Chemistry 07/19/2000
LIFESIGN LLC STATUS STREP A  
K983386 Streptococcus, Group A Bacteriology 05/17/2000
 
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