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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoassay, insulin-like growth factor binding protein-1
Regulation Description Urinary pH (nonquantitative) test system.
Definition The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.
Product CodeOAM
Regulation Number 862.1550
Device Class 1


Premarket Reviews
ManufacturerDecision
ALERE SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Adverse Event Without Identified Device or Use Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Rupture 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ACTIM OY II Apr-17-2024
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