# K123986: Actim Prom

- Pathway: 510(k) (Traditional)
- Applicant: Alere Scarborough, Inc.
- Decided: Jan 9, 2014 after 379 days
- Product code: OAM (Immunoassay, Insulin-Like Growth Factor Binding Protein-1)
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K030849 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061886: Actim Prom and Controls, Medix Biochemica (2007) Summary page 1.

## Recalls of this device
- Nov 23, 2023 · Class II · Z-1592-2024: Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.

## Indications for use
The Actim PROM test is a visually interpreted, qualitative immunoassay rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. The Actim PROM test detects IGFBP-1, a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a vaginal sample. The test is intended for prescription use in point of care and clinical laboratory settings to help diagnose the rupture of fetal membranes (ROM) in pregnant women > 29 weeks gestation who present with signs, symptoms or complaints suggestive of ROM.

Source page: https://510kreport.com/device/K123986
Methodology: https://510kreport.com/methodology