510(k) · Cleared

Recalled · Class II · 2013

BD Geneohm Cdiff Assay

K081920510(k) TraditionalCleared Dec 19, 2008169-day reviewClass I21 CFR 866.2660Recalls 4

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

Bd Diagnostics (Geneohm Sciences, Inc.) · LLH Reagents, Clostridium Difficile Toxin

Cleared on Dec 19, 2008 as substantially equivalent to K935296 (Techlab, Inc., 1994) and 1 other predicate after a 169-day review. Its family tree reaches back 1 generation to 1993. 18 later devices descend from it. It has been recalled 4 times.

Decided: Dec 19, 2008
Review: 169 days
Class: Class I
Product code: LLH
Recalls: 4
Predicates: 2

Its longest line of descent runs back 1 generation to K923463 (1993). 2 ancestors in all. 18 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
This deviceK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008
Descendant · cites it directly · 10 of its ownK130470 BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · Recalled
Descendant · 2 generations on · 5 of its ownK142422 cobas Cdiff TestRoche Molecular Systems, Inc. · 2015
Descendant · cites it directly · 5 of its ownK091109 Xpert C. DifficileCepheid · 2009
Descendant · 3 generations on · 4 of its ownK171770 cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2017
Descendant · 4 generations on · 2 of its ownK212427 cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2021

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2009high 3 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 18 · See all

K130470BD Max Cdiff Assay, BD Max InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2013 · cites it directly10descendants
K142422cobas Cdiff TestRoche Molecular Systems, Inc. · 2015 · 2 generations on5descendants
K091109Xpert C. DifficileCepheid · 2009 · cites it directly5descendants
K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2017 · 3 generations on4descendants
K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2021 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K923463	Clostridium Difficile Toxin/Antitoxin Kit	Techlab, Inc.	1993	—
0 (this device)	K081920	BD Geneohm Cdiff Assay	Bd Diagnostics (Geneohm Sciences, Inc.)	2008	—
+1	K130470	BD Max Cdiff Assay, BD Max Instrument	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	2013	2
+2	K142422	cobas Cdiff Test	Roche Molecular Systems, Inc.	2015	—
+1	K091109	Xpert C. Difficile	Cepheid	2009	—
+3	K171770	cobas Cdiff Nucleic acid test for use on the cobas Liat System	Roche Molecular Systems, Inc.	2017	—
+4	K212427	cobas Cdiff nucleic acid test for use on the cobas Liat System	Roche Molecular Systems, Inc.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2010	1	0
2011	2	0
2012	2	0
2013	2	0
2015	1	0
2017	3	0
2021	2	0
2023	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K081920, 1993–2026Source: 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 LLH? 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 LLH device

#1 K193490 SensiTox C. difficile Toxin Testscore 1.6 · 1 generation · no Class I recall

Get a 510(k) Report

What was it cleared against? (2)

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
*	K935296	Clostridium Difficile Tox-B Test Summary page 1 …: System, Test, Genotypic Detection, Clostridium difficile Toxin B Predicate Device: Techlab C. difficile Tox-B Test (K935296) Techlab Clostridium difficile Toxin/Antitoxin Kit (K923463) Device Description: Intended Use: Th…	Techlab, Inc.	1994	—
*	K923463	Clostridium Difficile Toxin/Antitoxin Kit Summary page 1 …Toxin B Predicate Device: Techlab C. difficile Tox-B Test (K935296) Techlab Clostridium difficile Toxin/Antitoxin Kit (K923463) Device Description: Intended Use: The BD GeneOhmTM Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative…	Techlab, Inc.	1993	—

Also cleared against K935296: 2 other devices →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K130470	BD Max Cdiff Assay, BD Max Instrument	Geneohm Sciences Canada, Inc. (Bd Diagnostics)	2013	10
K091109	Xpert C. Difficile	Cepheid	2009	5
K110203	Xpert C. Difficle/Epi Assay	Cepheid	2011	1
K113433	Simplexa C. Difficile Universal Direct	Focus Diagnostics, Inc.	2012	0
K090239	Progastro CD Assay	Prodesse, Inc.	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 11, 2013	Class II	Z-0790-2014	Error in labeling	An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
May 22, 2012	Class II	Z-2319-2012	Nonconforming Material/Component	Leakage in Cepheid SmartCycler reaction tubes.
May 22, 2012	Class II	Z-2318-2012	Nonconforming Material/Component	Leakage in Cepheid SmartCycler reaction tubes.
Mar 5, 2010	Not classified	Z-2174-2010	Nonconforming Material/Component	In vitro diagnostic test kits do not perform to specifications.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K130470 (Geneohm Sciences Canada, Inc. (Bd Diagnostics), 2013) has gone furthest, with 10 descendants of its own.
2 other devices also cite its predicate K935296.

How does its category compare?

All LLH devices

LLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LLH

1in 2021

2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLH

84in 2009

2007high 84 (2009)2026

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

Recalls per year · LLH

1in 2021

2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · LLH

1in 2025

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code LLH, 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	1	—	0	0
2008	2	—	0	0
2009	3	84	0	0
2010	1	—	1	1
2011	0	—	0	0
2012	0	—	2	0
2013	0	—	2	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	1	—	1	1
2022	0	—	0	1
2023	0	—	0	1
2024	0	—	0	1
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The BD GeneOhm TM Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K081920 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081920: BD Geneohm Cdiff Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081920

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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