510(k) Report

FDA product code · Clinical chemistry

Immunoassay For Detection Of Amniotic Fluid Protein (S).

NQMClass I21 CFR 862.1550510(k) exempt2 decisions since 20091 recall

FDA lists NQM as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 2009. 1 recall names this code; it is not Class I. The most-cited predicate is K081767, named by 1 later device.

The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of NQM at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NQM

1in 2011

2009: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NQM

Too few NQM 510(k)s in any year since 2007 to give a median.

Recalls per year · NQM

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NQM

1in 2025

2007: 12011: 72014: 52015: 32016: 12017: 32018: 72019: 52020: 52022: 12024: 12025: 1
2007high 7 (2011) · low 0 (2008)2025

MAUDE reports naming product code NQM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20091—00
20100—00
20111—07
20120—00
20130—00
20140—05
20150—03
20160—01
20170—03
20180—07
20190—05
20200—15
20210—00
20220—01
20230—00
20240—01
20250—01
20260—0—
FIG. 1 — NQM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NQM? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NQM devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K081767Amnisure Fetal Membranes Rupture Test, Model FMRT-1Amnisure International, LLC · 20091cites it

Which NQM devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K110605Rom PlusClinical Innovations, LLC · 20112generations

What has FDA decided in NQM lately?

  • K110605Rom PlusClinical Innovations, LLC · 20111 recall
  • K081767Amnisure Fetal Membranes Rupture Test, Model FMRT-1Amnisure International, LLC · 20091 Class I recall

All 2 NQM decisions →

What has been recalled in NQM lately?

  • K110605Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test…Clinical Innovations, LLC · Aug 13, 2020Class II

Related product codes

Other codes under 21 CFR 862.1550.

OAM Immunoassay, Insulin-Like Growth Factor…PDS Amniotic Fluid Protein ImmunoassayLNW Paper, Obstetric PhCEN Dye-Indicator, Ph (Urinary, Non-Quantitative)