NQM

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Immunoassay For Detection Of Amniotic Fluid Protein(S).

Device class

Class I (low risk)

Regulation

21 CFR 862.1550

Medical specialty

Clinical Chemistry

FDA definition

The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.

Adverse events (MAUDE)

2011: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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