510(k) · Cleared

Cleared

Immunocard C. Difficile GDH

K112048510(k) TraditionalCleared Dec 16, 2011151-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 Dec 16, 2011 as substantially equivalent to K053572 (Techlab, Inc., 2006) after a 151-day review. Its family tree reaches back 2 generations to 1987.

Decided: Dec 16, 2011
Review: 151 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.

By dateBy generation

Root · 2 generations backK870864 Culturette Brand CDT Clostridium Difficile TestMarion Laboratories, Inc. · 1987
1 generation backK053572 C. Diff Quik ChekTechlab, Inc. · 2006
This deviceK112048 Immunocard C. Difficile GDHMeridian Bioscience, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K870864	Culturette Brand CDT Clostridium Difficile Test	Marion Laboratories, Inc.	1987	—
−1	K053572	C. Diff Quik Chek	Techlab, Inc.	2006	—
0 (this device)	K112048	Immunocard C. Difficile GDH	Meridian Bioscience, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1998	1	0
2003	2	0

FIG. 1 — Lineage of K112048, 1987–2011Source: 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 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K053572	C. Diff Quik Chek Summary page 1 …tion: Antigen, C difficile MCB, CER Section 866.2660 Predicate device: K053572: TECHLAB C.01FF QUIK CHEKO Reference comparator: Bacterial culture Description of the device: ImmunoCard…	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 24 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. 2011, this device’s year, is highlighted.

FDA decisions per year · MCB

1in 2013

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	1	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	2	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	3
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	1	2
2022	0	—	0	2
2023	0	—	0	2
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

ImmunoCard C. clificile GDH is a rapid qualitative enzyme immunoassay screening

test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens

from persons suspected of having C. clifficile infection (CDI). This test does not

distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from

patients that produce positive results with this test must be further tested with an assay

designed to detect toxigenic C. clifficile strains and assist with the diagnosis of CDL.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112048 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112048: Immunocard 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/K112048

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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