# K030849: Amnisure Fetal Membranes Rupture Test Model FMRT1

- Pathway: 510(k) (Traditional)
- Applicant: N-Dia, Inc.
- Decided: Feb 2, 2004 after 322 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have 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
- K061886: Actim Prom and Controls (2007), 2 descendants of its own
- K123986: Actim Prom (2014), 0 descendants of its own
- K110605: Rom Plus (2011), 0 descendants of its own

## Recalls of this device
- Oct 3, 2007 · Not classified · Z-0120-2008: Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"

## Indications for use
The AmniSureTM ROM (Rupture Of [fetal] Membranes) Test is a rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal secretions 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 in pregnant women at > 34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM.

Source page: https://510kreport.com/device/K030849
Methodology: https://510kreport.com/methodology