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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device glucose oxidase, glucose
Regulation Description Glucose test system.
Product CodeCGA
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT POINT OF CARE INC.
  SUBSTANTIALLY EQUIVALENT 3
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERE SAN DIEGO, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
YSI INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 68 68
2021 48 48
2022 272 272
2023 1141 1141
2024 265 265
2025 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 656 656
Incorrect, Inadequate or Imprecise Result or Readings 365 365
Wireless Communication Problem 339 339
Electrical /Electronic Property Problem 201 201
High Test Results 80 80
Low Test Results 56 56
Erratic Results 49 49
Non Reproducible Results 36 36
Appropriate Term/Code Not Available 34 34
Communication or Transmission Problem 23 23
Material Integrity Problem 10 10
No Apparent Adverse Event 9 9
Low Readings 9 9
Failure to Sense 7 7
Patient Data Problem 7 7
Battery Problem 7 7
Insufficient Information 6 6
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Power Up 4 4
Inaccurate Information 3 3
Unauthorized Access to Computer System 3 3
Material Twisted/Bent 3 3
Problem with Software Installation 3 3
Device Alarm System 3 3
Display or Visual Feedback Problem 2 2
Physical Resistance/Sticking 2 2
Unable to Obtain Readings 1 1
High Readings 1 1
Moisture Damage 1 1
Obstruction of Flow 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Obtain Sample 1 1
Environmental Compatibility Problem 1 1
Expiration Date Error 1 1
Defective Component 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1
Device Markings/Labelling Problem 1 1
Display Difficult to Read 1 1
Failure of Device to Self-Test 1 1
Component Incompatible 1 1
Overheating of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1666 1666
Hypoglycemia 47 47
Insufficient Information 37 37
Hyperglycemia 27 27
No Consequences Or Impact To Patient 26 26
No Known Impact Or Consequence To Patient 22 22
Dizziness 5 5
No Patient Involvement 5 5
Shaking/Tremors 4 4
Loss of consciousness 4 4
Fatigue 3 3
Discomfort 3 3
Dysphasia 2 2
Test Result 2 2
Stroke/CVA 1 1
Complaint, Ill-Defined 1 1
Nausea 1 1
Diabetic Ketoacidosis 1 1
No Information 1 1
Burning Sensation 1 1
Convulsion/Seizure 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Respiratory Distress Syndrome of Newborns 1 1
Therapeutic Effects, Unexpected 1 1
Irritability 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Apr-30-2024
2 Alere San Diego, Inc. II Aug-06-2022
3 HemoCue AB II Jul-02-2025
4 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
5 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. III Sep-14-2022
6 Randox Laboratories Ltd. II Oct-31-2023
7 Siemens Healthcare Diagnostics Inc II Sep-15-2020
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