Product Code: LLH FDA class 1 21 CFR 866.2660

Reagents, Clostridium Difficile Toxin

Microbiology

Reagents, Clostridium Difficile Toxin are laboratory reagents used to detect the toxins produced by Clostridium difficile (now Clostridioides difficile) in stool specimens, supporting the diagnosis of C. difficile-associated diarrhea and colitis, a significant healthcare-associated infection. This device is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is LLH, regulated under 21 CFR 866.2660, within the Microbiology medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: LLH
Device Class: FDA class 1
Regulation Number: 866.2660
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K193490	SensiTox C. difficile Toxin Test	Jul 08, 2021	Substantially Equivalent	First Light Diagnostics, Inc.
K102242	OSOM C. DIFFICILE TOXIN A/B TEST	Dec 21, 2010	Substantially Equivalent	Genzyme Corporation
K091109	XPERT C. DIFFICILE	Jul 09, 2009	Substantially Equivalent	Cepheid
K090239	PROGASTRO CD ASSAY	Apr 16, 2009	Substantially Equivalent	Prodesse, Inc.
K082499	C. DIFF QUIK CHEK COMPLETE	Mar 26, 2009	Substantially Equivalent	Techlab, Inc.
K081920	BD GENEOHM CDIFF ASSAY	Dec 19, 2008	Substantially Equivalent	Bd Diagnostics (Geneohm Sciences, Inc.)
K080931	VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY	Jun 11, 2008	Substantially Equivalent	bioMerieux, Inc.
K072138	VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118	Dec 21, 2007	Substantially Equivalent	bioMerieux, Inc.
K050891	TOX A/B QUICK CHEK	Jul 25, 2005	Substantially Equivalent	Techlab, Inc.
K041951	XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B	Nov 15, 2004	Substantially Equivalent	Remel, Inc.
K041003	IMMUNOCARD TOXINS A & B, MODEL 712050	Aug 20, 2004	Substantially Equivalent	Meridian Bioscience, Inc.
K032897	C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96	May 27, 2004	Substantially Equivalent	Ivd Research, Inc.
K033479	PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY	Feb 26, 2004	Substantially Equivalent	Remel, Inc.
K030992	C. DIFF CHEK - 60	Jul 11, 2003	Substantially Equivalent	Techlab, Inc.
K030991	C. DIFF CHEK - 30	Jul 11, 2003	Substantially Equivalent	Techlab, Inc.
K030404	C. DIFFICILE TOX A/B II	Apr 24, 2003	Substantially Equivalent	Techlab, Inc.
K003306	C. DIFFICILE TOX A/B II	Nov 22, 2000	Substantially Equivalent	Techlab, Inc.
K993914	PREMIER TOXINS A&B, MODEL 616096	Dec 10, 1999	Substantially Equivalent	Meridian Diagnostics, Inc.
K991829	CDTOX A OIA	Nov 02, 1999	Substantially Equivalent	Biostar, Inc.
K990664	PRIMA SYSTEM - OLD, BARTELS ELISA - NEW	Mar 31, 1999	Substantially Equivalent	Intracel Corp.
K980185	COLORPAC TOXIN A	Jul 17, 1998	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K971182	TOX A/B TEST	Jul 22, 1997	Substantially Equivalent	Techlab, Inc.
K964887	VIDAS C. DIFFICILE TOXIN A II ASSAY	Apr 08, 1997	Substantially Equivalent	Biomerieux Vitek, Inc.
K964864	PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY	Feb 04, 1997	Substantially Equivalent	Alexon Biomedical, Inc.
K955859	IMMUNOCARD TOXIN A	Apr 18, 1996	Substantially Equivalent	Meridian Diagnostics, Inc.
K934493	PROSPECT MICROPLATE ASSAY	Sep 20, 1994	Substantially Equivalent	Alexon, Inc.
K935296	CLOSTRIDIUM DIFFICILE TOX-B TEST	Apr 26, 1994	Substantially Equivalent	Techlab, Inc.
K931129	TECHLAB 1-HOUR TOX-A-TEST	Sep 30, 1993	Substantially Equivalent	Techlab, Inc.
K925329	CULTURETTE BRAND TOXIN CD TEST	Mar 24, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K923463	CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT	Feb 01, 1993	Substantially Equivalent	Techlab, Inc.
K926442	PREMIER C. DIFFICILE, MODIFICATION	Jan 27, 1993	Substantially Equivalent	Meridian Diagnostics, Inc.
K924979	IMMUNOCARD(TM) C. DIFFICILE	Jan 26, 1993	Substantially Equivalent	Meridian Diagnostics, Inc.
K924136	PREMIER C. DIFFICILE TOXIN A CONTROLS	Oct 19, 1992	Substantially Equivalent	Meridian Diagnostics, Inc.
K914902	CLOSTRIDIUM DIFFICILE TOX-A-TEST	Mar 04, 1992	Substantially Equivalent	Techlab, Inc.
K905211	VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY	Oct 11, 1991	Substantially Equivalent	Vitek Systems, Inc.
K913229	BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN	Aug 29, 1991	Substantially Equivalent	Baxter Diagnostics, Inc.
K911958	CYTOCLONE A & B EIA	Jul 30, 1991	Substantially Equivalent	Cambridge Biotech Corp.
K903456	PREMIER-C. DIFFICILE TOXIN A	Oct 01, 1990	Substantially Equivalent	Meridian Diagnostics, Inc.
K883560	CDT CYTOTOXI TEST	Oct 25, 1988	Substantially Equivalent	Advanced Clinical Diagnostics
K870864	CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST	Apr 14, 1987	Substantially Equivalent	Marion Laboratories, Inc.
K863485	MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST	Sep 17, 1986	Substantially Equivalent	Marion Laboratories, Inc.
K852044	CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI	Jul 19, 1985	Substantially Equivalent	Marion Laboratories, Inc.