510(k) Report

FDA product code · Clinical chemistry

Immunoassay, Insulin-Like Growth Factor Binding Protein-1

OAMClass I21 CFR 862.1550510(k) exempt2 decisions since 20070 recalls

FDA lists OAM 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 2007. No recall names this code. The most-cited predicate is K061886, named by 2 later devices.

The device is a qualitative immunochromatographic test for the detection of amniotic fluid in cervicovaginal secretions. The test is intended for professional use to help diagnose the rupture of fetal membranes in pregnant women.

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 OAM 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 · OAM

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OAM

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

Recalls per year · OAM

No recall names OAM since 2007.

Adverse event reports per year · OAM

3in 2021

2013: 12020: 32021: 3
2007high 3 (2020) · low 0 (2007)2025

MAUDE reports naming product code OAM, 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
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—01
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—03
20210—03
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OAM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OAM? 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 OAM devices cite most?

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

  • K061886Actim Prom and ControlsMedix Biochemica · 20072cite it

Which OAM devices have the deepest lineage?

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

  • K123986Actim PromAlere Scarborough, Inc. · 20142generations
  • K061886Actim Prom and ControlsMedix Biochemica · 20071generation

What has FDA decided in OAM lately?

  • K123986Actim PromAlere Scarborough, Inc. · 20141 recall
  • K061886Actim Prom and ControlsMedix Biochemica · 2007

All 2 OAM decisions →

Related product codes

Other codes under 21 CFR 862.1550.

PDS Amniotic Fluid Protein ImmunoassayLNW Paper, Obstetric PhNQM Immunoassay For Detection Of Amniotic Fluid…CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)