510(k) · Cleared

Cleared

Amplivue C. Difficile Assay

K123355510(k) TraditionalCleared Dec 13, 201243-day reviewClass II21 CFR 866.3130

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

Quidel Corporation · OZN C. Difficile Toxin Gene Amplification Assay

Cleared on Dec 13, 2012 as substantially equivalent to DEN120013 (unknown applicant, ) after a 43-day review. 1 later device descends from it.

Decided: Dec 13, 2012
Review: 43 days
Class: Class II
Product code: OZN
Recalls: None
Predicates: 1

1 ancestor in all. 1 later device descends from it, 1 citing it directly.

This deviceK123355 Amplivue C. Difficile AssayQuidel Corporation · 2012
Descendant · cites it directly · 0 of its ownK132235 Imdx C.Difficile for Abbott M2000Intelligent Medical Devices, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all

K132235Imdx C.Difficile for Abbott M2000Intelligent Medical Devices, Inc. · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K123355	Amplivue C. Difficile Assay	Quidel Corporation	2012	—
+1	K132235	Imdx C.Difficile for Abbott M2000	Intelligent Medical Devices, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K123355, 2012–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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

Top candidate predicates for a new OZN device

#1 K260045 cobas® Cdiff Nucleic acid test for use on the…score 13.4 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN120013	C. Difficile Nucleic Acid Amplification Test Assay Our reading of the summary gave K113358, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120013, C. Difficile Nucleic Acid Amplification Test Assay (), granted —; older De Novo requests were first filed under a 510(k) number, so this links to the grant.			—

Also cleared against DEN120013: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132235	Imdx C.Difficile for Abbott M2000	Intelligent Medical Devices, Inc.	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K132235 (Intelligent Medical Devices, Inc., 2013) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate DEN120013.

How does its category compare?

All OZN devices

OZN C. Difficile Toxin Gene Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OZN

1in 2025

2007high 5 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OZN

89in 2017

2007high 89 (2017) · low 79 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OZN

2in 2025

2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · OZN

3in 2025

2007high 7 (2024) · low 0 (2007)2025

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

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	0	—	0	0
2011	0	—	0	0
2012	2	—	0	0
2013	4	79	0	0
2014	1	—	0	0
2015	1	—	0	0
2016	0	—	0	0
2017	5	89	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	2	—	0	5
2022	0	—	0	1
2023	1	—	0	2
2024	0	—	1	7
2025	1	—	2	3
2026	1	—	0	—

What is it indicated for?

The AmpliVueTM C. difficile assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridium difficile-associated disease (CDAD). The AmpliVue T M C. difficile assay is intended for use as an aid in diagnosis of CDAD. The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Toxin A gene sequence and a self-contained disposable amplification detection device that allows for manual evaluation of assay results.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123355 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123355: Amplivue C. Difficile Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123355

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026