# K110605: Rom Plus

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, LLC
- Decided: Nov 23, 2011 after 266 days
- Product code: NQM (Immunoassay For Detection Of Amniotic Fluid Protein(S).)
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has 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.
- K081767: Amnisure Fetal Membranes Rupture Test, Model FMRT-1, Amnisure International, LLC (2009) Summary page 1.
- K061886: Actim Prom and Controls, Medix Biochemica (2007) Summary page 1.
- K914419: Amniotest (TM), Pro-Lab, Inc. (1993) Summary page 1.
- K071100: Amniscreen Home Detection Liner Kit, Common Sense, Ltd. (2007) Summary page 1.

## Recalls of this device
- Aug 13, 2020 · Class II · Z-0541-2021: Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the sw

## Indications for use
The Clinical Innovations ROM Plus fetal membrane rupture test is a rapid, qualitative immunochromatographic test for the in-vitro detection of amniotic fluid in vaginal secretions of pregnant women with signs and symptoms of ROM. The test detects AFP (alpha-fetoprotein) and PPI12 (placental protein 12 or insulin growth factor binding protein) from amniotic fluid in vaginal secretion. The test is for prescription use by health care professionals to aid in the detection of rupture of membranes (ROM) in pregnant women in conjunction with other signs and symptoms. The ROM Plus Quality Control Kit monitors the performance of the ROM Plus Fetal Membranes Rupture Test for the purposes of external quality control. The lyophilized human positive protein control is an assayed control material for qualitative testing.

Source page: https://510kreport.com/device/K110605
Methodology: https://510kreport.com/methodology