510(k) · Cleared

Cleared

Quidel Molecular Direct C. Difficile Assay

K123998510(k) TraditionalCleared Mar 8, 201372-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 Corp. · OZN C. Difficile Toxin Gene Amplification Assay

Cleared on Mar 8, 2013 as substantially equivalent to DEN120013 (unknown applicant, ) after a 72-day review. 2 later devices descend from it.

Decided: Mar 8, 2013
Review: 72 days
Class: Class II
Product code: OZN
Recalls: None
Predicates: 1

1 ancestor in all. 2 later devices descend from it, 2 citing it directly.

This deviceK123998 Quidel Molecular Direct C. Difficile AssayQuidel Corp. · 2013
Descendant · cites it directly · 0 of its ownK171441 ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay…Luminex Corporation · 2017 · Recalled
Descendant · cites it directly · 0 of its ownK133936 Artus C. Difficile QS-RGQ MDX KitQIAGEN GmbH · 2014

Most influential descendants

Showing 2 of 2 · See all

K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…Luminex Corporation · 2017 · cites it directly0descendants
K133936Artus C. Difficile QS-RGQ MDX KitQIAGEN GmbH · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K123998	Quidel Molecular Direct C. Difficile Assay	Quidel Corp.	2013	—
+1	K171441	ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File…	Luminex Corporation	2017	1
+1	K133936	Artus C. Difficile QS-RGQ MDX Kit	QIAGEN GmbH	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2017	1	0

FIG. 1 — Lineage of K123998, 2013–2017Source: 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

Get a 510(k) Report

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? (2)

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

Number	Device	Applicant	Decided	Descendants
K171441	ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…	Luminex Corporation	2017	0
K133936	Artus C. Difficile QS-RGQ MDX Kit	QIAGEN GmbH	2014	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, K171441 (Luminex Corporation, 2017) 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. 2013, 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 Quidel Molecular Direct C. difficile Assay is a qualitative, multiplexed in vitro diagnostic test for the direct detection of toxin A gene (tcdA4) or toxin B gene (tcdB) sequences of toxigenic strains of Clostridium dificile from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridiumdifficile-Associated Disease (CDAD). The Quidel Molecular Direct C. difficile Assay is a real-time PCR test and utilizes…

Read the full statement (135 words)

The Quidel Molecular Direct C. difficile Assay is a real-time PCR test and utilizes proprietary sample preparation with fluorescently labeled primers and probes. The assay can be performed using either the Life Technologies QuantStudiog Dx; the Applied Biosystems 7500 Fast Dx, or the Cepheid SmartCycler 11, to detect the toxin gene sequences associated with toxin-producing C. dffficile strains.

The assay is intended to be performed directly on CDAD-suspected stool specimens, and is indicated for use as an aid in the diagnosis of CDAD.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123998 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123998: Quidel Molecular Direct C. Difficile Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123998

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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