FDA product code · Microbiology

C. Difficile Nucleic Acid Amplification Test Assay

Name: FDA decisions, review times, recalls and adverse event reports for product code OMN
Creator: 510(k) Report

OMNClass I21 CFR 866.2660510(k) exempt5 decisions since 20101 recall

FDA lists OMN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 5 FDA decisions since 2010. 1 recall names this code; it is not Class I. The most-cited predicate is DEN120013, named by 4 later devices.

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

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, microbiology panel

Twenty years of OMN 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 · OMN

1in 2012

2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMN

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

Recalls per year · OMN

1in 2025

2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · OMN

No MAUDE report names OMN since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	2	—	0	0
2012	1	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	1	0
2026	0	—	0	—

FIG. 1 — OMN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OMN? 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

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Other codes under 21 CFR 866.2660.

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C. Difficile Nucleic Acid Amplification Test Assay

Which predicates do OMN devices cite most?

Which OMN devices have the deepest lineage?

What has FDA decided in OMN lately?

What has been recalled in OMN lately?

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