# NQM: Immunoassay For Detection Of Amniotic Fluid Protein (S).

- Device class: 1; regulation: 21 CFR 862.1550; FDA's rule: 510(k) exempt
- FDA decisions: 2
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 1
- 2011: 1

## Most-cited predicates
- K081767: Amnisure Fetal Membranes Rupture Test, Model FMRT-1 (2009), cited by 1

Source page: https://510kreport.com/product-code/NQM
Data by year (CSV): https://510kreport.com/product-code/NQM.csv