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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device method, enzymatic, glucose (urinary, non-quantitative)
Regulation Description Urinary glucose (nonquantitative) test system.
Product CodeJIL
Regulation Number 862.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ARKRAY INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 23 23
2021 12 12
2022 14 14
2023 15 15
2024 21 21
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 29 29
Smoking 22 22
False Positive Result 13 13
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Electrical /Electronic Property Problem 4 4
Non Reproducible Results 3 3
Patient Data Problem 2 2
Device Difficult to Setup or Prepare 2 2
High Test Results 2 2
Optical Problem 2 2
No Device Output 2 2
Low Test Results 2 2
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
High Readings 1 1
Missing Test Results 1 1
Incorrect Measurement 1 1
Low Readings 1 1
No Apparent Adverse Event 1 1
Missing Information 1 1
Overheating of Device 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 65 65
No Consequences Or Impact To Patient 17 17
No Patient Involvement 4 4
Insufficient Information 3 3
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Macherey Nagel Gmbh & Co. Kg II May-16-2024
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