510(k) Report

510(k) · Cleared

Cleared

Premier C. Difficile GDH

K110620510(k) TraditionalCleared May 3, 201161-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

Meridian Bioscience, Inc. · MCB Antigen, C. Difficile

Cleared on May 3, 2011 as substantially equivalent to K030992 (Techlab, Inc., 2003) after a 61-day review. Its family tree reaches back 1 generation to 2003.

Decided
May 3, 2011
Review
61 days
Class
Class I
Product code
MCB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K030992 (2003). No later device cites it as a predicate yet.

K030992 · C. Diff Chek - 60 · Techlab, Inc. · 20032000200220042006200820102012
K030992 · C. Diff Chek - 60 · Techlab, Inc. · 20030
  1. Root · 1 generation backK030992 C. Diff Chek - 60Techlab, Inc. · 2003
  2. This deviceK110620 Premier C. Difficile GDHMeridian Bioscience, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K030992C. Diff Chek - 60Techlab, Inc.2003—
0 (this device)K110620Premier C. Difficile GDHMeridian Bioscience, Inc.2011—
FIG. 1 — Lineage of K110620, 2003–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K030992C. Diff Chek - 60
Summary page 1
…ication: Antigen, C.duff/ciue MCB, CFR Section 866.2660 Predicate device: K030992: TECHLAB C.DIFF CHEK ELISA -M_60 Refer…
Techlab, Inc.2003—

Also cleared against K030992: 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?

  • Its one ancestor has no recall.
  • 2 other devices also cite its predicate K030992.

How does its category compare?

All MCB devices

MCB Antigen, C. Difficile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?

Premier C. difficile GDH is a qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from symptomatic persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from symptomatic patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.

Indications for use as stated in the FDA summary.

Also cleared against K030992

2 other devices cite the same predicate.

  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009
  • K053572C. Diff Quik ChekTechlab, Inc. · 2006

More from Meridian Bioscience, Inc.

53 FDA decisions under this applicant name. See the company

  • K243922RevogeneMeridian Bioscience, Inc. · 2025
  • K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023
  • K222829Curian® Shiga ToxinMeridian Bioscience, Inc. · 2023
  • K222779RevogeneMeridian Bioscience, Inc. · 2023
  • K220480RevogeneMeridian Bioscience, Inc. · 2022

Recent decisions in MCB

The MCB category page

  • K132010Vidas C Difficile GDHBiomerieux S.A. · 2013
  • K112048Immunocard 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/K110620 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110620: Premier 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/K110620

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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