510(k) Report

510(k) · Cleared

Recalled · 2007

Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a

K974881510(k) TraditionalCleared Mar 20, 199880-day reviewClass I21 CFR 866.2660Recalls 1

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

Biosite Incorporated · MCB Antigen, C. Difficile

Cleared on Mar 20, 1998 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.

Decided
Mar 20, 1998
Review
80 days
Class
Class I
Product code
MCB
Recalls
1
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared2011: 1 descendant cleared1995200020052010201520202025
  1. This deviceK974881 Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile…Biosite Incorporated · 1998
  2. Descendant · cites it directly · 3 of its ownK053572 C. Diff Quik ChekTechlab, Inc. · 2006
  3. Descendant · 2 generations on · 0 of its ownK132010 Vidas C Difficile GDHBiomerieux S.A. · 2013
  4. Descendant · 2 generations on · 0 of its ownK112048 Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011
  5. Descendant · cites it directly · 0 of its ownK082499 C. Diff Quik Chek CompleteTechlab, Inc. · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K053572C. Diff Quik ChekTechlab, Inc. · 2006 · cites it directly3descendants
  • K132010Vidas C Difficile GDHBiomerieux S.A. · 2013 · 2 generations on0descendants
  • K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011 · 2 generations on0descendants
  • K082499C. Diff Quik Chek CompleteTechlab, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974881Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin aBiosite Incorporated1998—
+1K053572C. Diff Quik ChekTechlab, Inc.2006—
+2K132010Vidas C Difficile GDHBiomerieux S.A.2013—
+2K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc.2011—
+1K082499C. Diff Quik Chek CompleteTechlab, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201110
201310
FIG. 1 — Lineage of K974881, 1998–2013Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K053572C. Diff Quik ChekTechlab, Inc.20063
K082499C. Diff Quik Chek CompleteTechlab, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 4, 2007Not classifiedZ-1352-2008Process designFalse Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K053572 (Techlab, Inc., 2006) has gone furthest, with 3 descendants of its own.

How does its category compare?

All MCB devices

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

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?

The Triage® C. difficile test is an enzyme immunoassay used for the detection of Clostridium difficile antigen (glutamate dehydrogenase or common antigen) and Toxin A in human fecal specimens. The test will be offered as two singular tests for each protein. This test is used as an aid in the diagnosis of C. difficile associated disease.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Biosite Incorporated

46 FDA decisions under this applicant name. See the company

  • K092987Inratio/INRATIO2 Test StripsBiosite Incorporated · 20106 Class I recalls
  • K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated · 2010
  • K093032Triage Total 3 Controls and Calibration Verification SetBiosite Incorporated · 2009
  • K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 20082 Class I recalls
  • K072892Triage Total Controls 5, Triage Total Calibration Verification 5Biosite Incorporated · 20075 recalls

Recent decisions in MCB

The MCB category page

  • K132010Vidas C Difficile GDHBiomerieux S.A. · 2013
  • K112048Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K110620Premier C. Difficile GDHMeridian Bioscience, Inc. · 2011
  • K053572C. Diff Quik ChekTechlab, Inc. · 2006
  • K955067Clearview C. Diff aUnipath, Ltd. · 1996

https://510kreport.com/device/K974881 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974881: Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974881

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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