Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device glucose oxidase, glucose
Product CodeCGA
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT POINT OF CARE INC.
  SUBSTANTIALLY EQUIVALENT 4
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
  SUBSTANTIALLY EQUIVALENT 1
ALERE SAN DIEGO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLIANCE INTERNATIONAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
APEX BIO TECHNOLOGY CORP
  SUBSTANTIALLY EQUIVALENT 1
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 8
ARKRAY FACTORY INC.
  SUBSTANTIALLY EQUIVALENT 2
ARKRAY FACTORY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BESTGEN BIOTECH CORP.
  SUBSTANTIALLY EQUIVALENT 2
BROADMASTER BIOTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DIATRON GROUP
  SUBSTANTIALLY EQUIVALENT 1
EOSHEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPOCAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EPS BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
FORA CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
HUBDIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INFOPIA CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORP.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILOSYS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
POLYMER TECHNOLOGY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
POLYMER TECHNOLOGY SYSTEMS, INC. D/B/A PTS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
SENDX MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
SEPPIM S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
SIMPLE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPHERE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2014 122 122
2015 155 155
2016 36 36
2017 92 92
2018 69 69
2019 116 116
2020 68 68
2021 48 48
2022 276 276
2023 1159 1159
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 686 686
Incorrect, Inadequate or Imprecise Result or Readings 379 379
Wireless Communication Problem 357 357
Electrical /Electronic Property Problem 253 253
High Test Results 174 174
Low Test Results 111 111
Incorrect Or Inadequate Test Results 66 66
Appropriate Term/Code Not Available 38 38
Non Reproducible Results 34 34
High Readings 27 27
Communication or Transmission Problem 24 24
Failure to Power Up 23 23
Overheating of Device 19 19
Low Readings 16 16
Device Operates Differently Than Expected 13 13
Battery Problem 11 11
Insufficient Information 11 11
Image Display Error/Artifact 9 9
No Apparent Adverse Event 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Patient Data Problem 7 7
Failure to Sense 7 7
Material Integrity Problem 7 7
Device Displays Incorrect Message 6 6
Smoking 6 6
Improper or Incorrect Procedure or Method 6 6
Defective Component 6 6
Device Emits Odor 5 5
Thermal Decomposition of Device 5 5
Problem with Software Installation 5 5
Output Problem 4 4
Circuit Failure 4 4
Device Alarm System 4 4
Peeled/Delaminated 4 4
Nonstandard Device 4 4
Component Missing 4 4
Defective Device 4 4
Material Twisted/Bent 3 3
Unable to Obtain Readings 3 3
Loss of Power 3 3
No Display/Image 3 3
Unauthorized Access to Computer System 3 3
Physical Resistance/Sticking 3 3
Inaccurate Information 3 3
Noise, Audible 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
Packaging Problem 2 2
Display or Visual Feedback Problem 2 2
Image Resolution Poor 2 2
Hole In Material 2 2
False Reading From Device Non-Compliance 2 2
Fluid/Blood Leak 2 2
Incorrect Measurement 2 2
Mechanical Problem 2 2
Use of Device Problem 2 2
Inaccurate Delivery 2 2
Device Markings/Labelling Problem 2 2
Failure to Obtain Sample 2 2
Difficult or Delayed Activation 1 1
Low Battery 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Charging Problem 1 1
Device Operational Issue 1 1
Environmental Compatibility Problem 1 1
Failure of Device to Self-Test 1 1
Human Factors Issue 1 1
Inadequate Lighting 1 1
Issue With Displayed Error Message 1 1
Obstruction of Flow 1 1
Out-Of-Box Failure 1 1
Expiration Date Error 1 1
Sticking 1 1
Inadequate Storage 1 1
Invalid Sensing 1 1
Device Damaged Prior to Use 1 1
Melted 1 1
Moisture Damage 1 1
Material Fragmentation 1 1
No Device Output 1 1
Shelf Life Exceeded 1 1
Off-Label Use 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Device Expiration Issue 1 1
Fail-Safe Design Failure 1 1
Changes In Ambient Temperature In Device Environment 1 1
Loss of or Failure to Bond 1 1
Component Incompatible 1 1
Failure to Cycle 1 1
Material Discolored 1 1
Display Difficult to Read 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Explosion 1 1
Device Handling Problem 1 1
Data Problem 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1505 1505
No Known Impact Or Consequence To Patient 388 388
No Consequences Or Impact To Patient 116 116
Hypoglycemia 60 60
Hyperglycemia 40 40
Insufficient Information 36 36
No Patient Involvement 33 33
No Information 15 15
Dizziness 12 12
Shaking/Tremors 11 11
Loss of consciousness 9 9
Sweating 8 8
Fatigue 6 6
Nausea 5 5
Weakness 5 5
No Code Available 5 5
Test Result 3 3
Polydipsia 3 3
Ambulation Difficulties 3 3
Confusion/ Disorientation 3 3
Dysphasia 3 3
Urinary Frequency 3 3
Discomfort 3 3
Overdose 3 3
Headache 3 3
Seizures 2 2
Skin Irritation 2 2
Complaint, Ill-Defined 2 2
Malaise 2 2
Diabetic Ketoacidosis 2 2
Anxiety 2 2
Distress 1 1
Electrolyte Imbalance 1 1
Burning Sensation 1 1
Chills 1 1
Numbness 1 1
Hypoesthesia 1 1
Needle Stick/Puncture 1 1
Irritability 1 1
Swollen Lymph Nodes 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Pain 1 1
Renal Failure 1 1
Respiratory Distress Syndrome of Newborns 1 1
Hemorrhage/Bleeding 1 1
Death, Intrauterine Fetal 1 1
Fever 1 1
Abnormal Blood Gases 1 1
Syncope 1 1
Endophthalmitis 1 1
Fainting 1 1
Lethargy 1 1
Chemical Exposure 1 1
Sleep Dysfunction 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Dec-10-2010
2 Abbott Point of Care Inc. III Sep-23-2010
3 Abbott Point of Care Inc. II Mar-15-2010
4 Abbott Point of Care Inc. III Feb-24-2010
5 Abbott Point of Care Inc. II Sep-30-2009
6 Alere San Diego, Inc. II Aug-06-2022
7 Alere San Diego, Inc. III Nov-22-2013
8 Arkray Factory USA, Inc. I Jan-15-2016
9 Beckman Coulter Inc. II Sep-09-2010
10 Biosite Inc Dba Innovacon Inc. II Jun-01-2011
11 DIABETIC SUPPLY OF SUNCOAST, INC. I Jul-22-2014
12 ELITech Clinical Systems SAS II Nov-05-2015
13 Epocal II Aug-14-2013
14 Epocal Inc II Jul-19-2012
15 Hemo Cue, Inc. III Jan-20-2012
16 Hemo Cue, Inc. II Mar-30-2011
17 HemoCue AB II Sep-11-2013
18 Instrumentation Laboratory Co. II May-10-2011
19 JAS Diagnostics Inc. II Jun-25-2014
20 Medline Industries Inc II Nov-22-2019
21 Nova Biomedical Corporation II Jan-09-2014
22 Nova Biomedical Corporation II Apr-19-2013
23 Nova Biomedical Corporation II Jun-10-2010
24 Ortho-Clinical Diagnostics II Aug-06-2019
25 Ortho-Clinical Diagnostics II Oct-17-2016
26 Ortho-Clinical Diagnostics II Nov-15-2013
27 Osmetech Inc II Jun-25-2015
28 Pointe Scientific, Inc. II Mar-12-2009
29 Polymer Technology Systems, Inc. II May-23-2019
30 Polymer Technology Systems, Inc. II Mar-05-2010
31 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. III Sep-14-2022
32 Radiometer America Inc II Dec-24-2014
33 Randox Laboratories Ltd. II Oct-31-2023
34 Roche Diagnostics Operations, Inc. II Feb-02-2015
35 Siemens Healthcare Diagnostics Inc II Sep-15-2020
36 Siemens Healthcare Diagnostics, Inc II Jul-02-2015
37 Siemens Healthcare Diagnostics, Inc. II May-11-2016
38 Sterling Diagnostics, Inc. III Dec-29-2016
-
-