510(k) Report

510(k) · Cleared

Cleared

Vidas C Difficile GDH

K132010510(k) TraditionalCleared Oct 9, 2013100-day reviewClass 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

Biomerieux S.A. · MCB Antigen, C. Difficile

Cleared on Oct 9, 2013 as substantially equivalent to K053572 (Techlab, Inc., 2006) after a 100-day review. Its family tree reaches back 2 generations to 1987.

Decided
Oct 9, 2013
Review
100 days
Class
Class I
Product code
MCB
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K870864 (1987). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors1998: 1 other ancestor1993: 1 other ancestorK870864 · Culturette Brand CDT Clostridium Difficile Test · Marion Laboratories, Inc. · 1987K053572 · C. Diff Quik Chek · Techlab, Inc. · 20061985199019952000200520102015
Other ancestors, by generation 2 generations back: 4 other ancestors K053572 · C. Diff Quik Chek · Techlab, Inc. · 2006K870864 · Culturette Brand CDT Clostridium Difficile Test · Marion Laboratories, Inc. · 19870
  1. Root · 2 generations backK870864 Culturette Brand CDT Clostridium Difficile TestMarion Laboratories, Inc. · 1987
  2. 1 generation backK053572 C. Diff Quik ChekTechlab, Inc. · 2006
  3. This deviceK132010 Vidas C Difficile GDHBiomerieux S.A. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K870864Culturette Brand CDT Clostridium Difficile TestMarion Laboratories, Inc.1987—
−1K053572C. Diff Quik ChekTechlab, Inc.2006—
0 (this device)K132010Vidas C Difficile GDHBiomerieux S.A.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199810
200320
FIG. 1 — Lineage of K132010, 1987–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 MCB? 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

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.

TypeNumberDeviceApplicantDecidedRecalls
*K053572C. Diff Quik Chek
Summary page 1
…Identification Device MCB - Antigen, Clostridium difficile C. Predicate Device Name Trade Name: C. DIFF QUIK CHEK®(TECHLAB, INC.), K053572 D. Device Description The VIDAS' C. difficile GDH assay principle combines a two-step enzyme immunoassay sandwich method with a f…
Techlab, Inc.2006—

Also cleared against K053572: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K053572.

How does its category compare?

All MCB devices

MCB Antigen, C. Difficile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · MCB

1in 2013

2011: 22013: 1
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MCB

Too few MCB 510(k)s in any year since 2007 to give a median.

Recalls per year · MCB

1in 2021

2007: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · MCB

2in 2023

2018: 32021: 22022: 22023: 2
2007high 3 (2018) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—10
20080—00
20090—00
20100—00
20112—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—03
20190—00
20200—00
20210—12
20220—02
20230—02
20240—00
20250—00
20260—0—

What is it indicated for?

VIDASO C. difficile GDH (GDH) is an automated test based on the Enzyme linked Fluorescent Assay technique (ELFA), for use on the VIDAS family instruments. The VIDAS C. diftiile GDH (glutamate dehydrogenase) assay is a qualitative test that detects the C. diffloile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile in fecal specimens from persons suspected of having C. difficile infection (CDI). The test does not distinguish…

Read the full statement (121 words)

VIDASO C. difficile GDH (GDH) is an automated test based on the Enzyme linked Fluorescent Assay technique (ELFA), for use on the VIDAS family instruments.

The VIDAS C. diftiile GDH (glutamate dehydrogenase) assay is a qualitative test that detects the C. diffloile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile in fecal specimens from persons suspected of having C. difficile infection (CDI). The test does not distinguish toxigenic from non-toxigenic strains of C. difficile. With the use of additional tests that detect C. difficile toxins, the test is to be used as an aid in the diagnosis of C. dufficile infection. As wvith other C. difficile tests, results should be considered in conjunction wvith the patient history.

Indications for use as stated in the FDA summary.

Also cleared against K053572

2 other devices cite the same predicate.

  • K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009

More from Biomerieux S.A.

16 FDA decisions under this applicant name. See the company

  • K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)Biomerieux S.A. · 2025
  • K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)Biomerieux S.A. · 2021
  • K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)Biomerieux S.A. · 2019
  • K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)Biomerieux S.A. · 20191 recall
  • K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A. · 20192 recalls

Recent decisions in MCB

The MCB category page

  • K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K110620Premier C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K053572C. Diff Quik ChekTechlab, Inc. · 2006
  • K974881Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin aBiosite Incorporated · 19981 recall
  • K955067Clearview C. Diff aUnipath, Ltd. · 1996

https://510kreport.com/device/K132010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132010: Vidas C Difficile GDH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132010

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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