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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, glycosylated hemoglobin
Regulation Description Glycosylated hemoglobin assay.
Product CodeLCP
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
  SUBSTANTIALLY EQUIVALENT 1
JANA CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K192987  Aina HbA1c Monitoring System 2
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QURASENSE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 7 8
2022 8 8
2023 27 27
2024 39 39
2025 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 58 58
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Non Reproducible Results 19 19
Low Test Results 10 10
Output Problem 5 5
Use of Device Problem 4 4
No Apparent Adverse Event 4 4
Chemical Problem 2 2
Insufficient Information 2 2
Smoking 2 2
Incorrect Measurement 2 2
Appropriate Term/Code Not Available 2 2
Leak/Splash 1 1
Fire 1 1
Mechanical Problem 1 1
Device Markings/Labelling Problem 1 1
Fail-Safe Did Not Operate 1 1
Material Integrity Problem 1 1
Patient Data Problem 1 1
High Readings 1 1
Unable to Obtain Readings 1 2
Calibration Problem 1 1
Data Problem 1 1
Low Readings 1 1
Failure to Calibrate 1 1
Unexpected Therapeutic Results 1 1
Failure to Analyze Signal 1 1
False Positive Result 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 99 100
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Exposure to Body Fluids 1 1
No Patient Involvement 1 1
Insufficient Information 1 1
Hyperglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Technologies AS II Aug-27-2024
2 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
3 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. II Oct-24-2024
4 Siemens Healthcare Diagnostics, Inc. II Mar-19-2024
5 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
6 Siemens Healthcare Diagnostics, Inc. II Jul-31-2020
7 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
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