# K061886: Actim Prom and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Medix Biochemica
- Decided: Jan 25, 2007 after 206 days
- Product code: OAM (Immunoassay, Insulin-Like Growth Factor Binding Protein-1)
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030849 (2004). 1 ancestor in all.
2 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)
- K030849: Amnisure Fetal Membranes Rupture Test Model FMRT1, N-Dia, Inc. (2004) Summary page 1.

## Most influential descendants
- K123986: Actim Prom (2014), 0 descendants of its own
- K110605: Rom Plus (2011), 0 descendants of its own

## Indications for use
The Actim PROM test is a visually interpreted, qualitative immunochromatographic rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. Actim PROM test detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a cervicovaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women at >34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM or if such signs are otherwise observed. The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.

Source page: https://510kreport.com/device/K061886
Methodology: https://510kreport.com/methodology