# K081767: Amnisure Fetal Membranes Rupture Test, Model FMRT-1

- Pathway: 510(k) (Traditional)
- Applicant: Amnisure International, LLC
- Decided: Jan 9, 2009 after 203 days
- Product code: NQM (Immunoassay For Detection Of Amniotic Fluid Protein(S).)
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110605: Rom Plus (2011), 0 descendants of its own

## Recalls of this device
- Feb 21, 2020 · Class II · Z-1636-2020: An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
- May 18, 2018 · Class I · Z-2577-2018: Potential for control line not appearing on the test strip

## Indications for use
The Amnisure® ROM (rupture of fetal membrane) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretion of pregnant women. Amnisure® detects PAMG-1 protein marker of the amniotic fluid in vaginal secretions. The test is for use by health care professionals to aid in the detection of ROM when patients report signs, symptoms or complaints suggestive of ROM.

Source page: https://510kreport.com/device/K081767
Methodology: https://510kreport.com/methodology