510(k) Report

De Novo · Granted

Granted

C. Difficile Nucleic Acid Amplification Test Assay

DEN120013De NovoClass I21 CFR 866.2660

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

Unknown applicant · OMN C. Difficile Nucleic Acid Amplification Test Assay

Granted as a new device type through De Novo. 7 later devices descend from it.

Class
Class I
Product code
OMN
Recalls
None

7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2017: 2 descendants cleared2013: 2 descendants cleared2014: 1 descendant cleared
  1. This deviceDEN120013 C. Difficile Nucleic Acid Amplification Test Assay ·
  2. Descendant · cites it directly · 2 of its ownK123998 Quidel Molecular Direct C. Difficile AssayQuidel Corp. · 2013
  3. Descendant · cites it directly · 1 of its ownK123355 Amplivue C. Difficile AssayQuidel Corporation · 2012
  4. Descendant · 2 generations on · 0 of its ownK171441 ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay…Luminex Corporation · 2017 · Recalled
  5. Descendant · cites it directly · 0 of its ownK170491 Solana C. difficile AssayQuidel Corporation · 2017
  6. Descendant · 2 generations on · 0 of its ownK133936 Artus C. Difficile QS-RGQ MDX KitQIAGEN GmbH · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 22013: 22014: 12017: 2
2012high 2 (2012) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K123998Quidel Molecular Direct C. Difficile AssayQuidel Corp. · 2013 · cites it directly2descendants
  • K123355Amplivue C. Difficile AssayQuidel Corporation · 2012 · cites it directly1descendant
  • K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…Luminex Corporation · 2017 · 2 generations on0descendants
  • K170491Solana C. difficile AssayQuidel Corporation · 2017 · cites it directly0descendants
  • K133936Artus C. Difficile QS-RGQ MDX KitQIAGEN GmbH · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN120013C. Difficile Nucleic Acid Amplification Test Assay—
+1K123998Quidel Molecular Direct C. Difficile AssayQuidel Corp.2013—
+1K123355Amplivue C. Difficile AssayQuidel Corporation2012—
+2K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File…Luminex Corporation20171
+1K170491Solana C. difficile AssayQuidel Corporation2017—
+2K133936Artus C. Difficile QS-RGQ MDX KitQIAGEN GmbH2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201320
201410
201720
FIG. 1 — Lineage of DEN120013, –2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OMN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123998Quidel Molecular Direct C. Difficile AssayQuidel Corp.20132
K123355Amplivue C. Difficile AssayQuidel Corporation20121
K170491Solana C. difficile AssayQuidel Corporation20170
K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.20120

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K123998 (Quidel Corp., 2013) has gone furthest, with 2 descendants of its own.

How does its category compare?

All OMN devices

OMN C. Difficile Nucleic Acid Amplification Test Assay: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OMN

1in 2012

2010: 12011: 22012: 1
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

2025: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20112—00
20121—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

Recent decisions in OMN

The OMN category page

  • K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012
  • K110203Xpert C. Difficle/Epi AssayCepheid · 2011
  • K110012Illumigene C. Difficile, and Illumipro-10Meridian Bioscience, Inc. · 20112 recalls
  • K100818Illumigene C. Difficile, Illumipro-10 and Illumigene C. Difficile External Control Kit, Models 280050…Meridian Bioscience, Inc. · 2010

https://510kreport.com/device/DEN120013 · printed Nov 4, 2026

Cite this page

510(k) Report. “DEN120013: C. Difficile Nucleic Acid Amplification Test Assay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN120013

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026