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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

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

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 and Conditions Term/Code Not Available 1 1

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