510(k) · Cleared

Cleared

Progastro CD Assay

K090239510(k) TraditionalCleared Apr 16, 200973-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

Prodesse, Inc. · LLH Reagents, Clostridium Difficile Toxin

Cleared on Apr 16, 2009 as substantially equivalent to K923463 (Techlab, Inc., 1993) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 1993.

Decided: Apr 16, 2009
Review: 73 days
Class: Class I
Product code: LLH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K923463 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK923463 Clostridium Difficile Toxin/Antitoxin KitTechlab, Inc. · 1993
1 generation backK081920 BD Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) · 2008 · Recalled
This deviceK090239 Progastro CD AssayProdesse, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K923463	Clostridium Difficile Toxin/Antitoxin Kit	Techlab, Inc.	1993	—
−1	K081920	BD Geneohm Cdiff Assay	Bd Diagnostics (Geneohm Sciences, Inc.)	2008	4
0 (this device)	K090239	Progastro CD Assay	Prodesse, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K090239, 1993–2009Source: 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 LLH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLH device

#1 K193490 SensiTox C. difficile Toxin Testscore 1.6 · 1 generation · no Class I recall

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What was it cleared against? (2)

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
*	K923463	Clostridium Difficile Toxin/Antitoxin Kit Summary page 1 …ProGastro Cd Assay Regulation Number: 21 CFR 866.2660 Classification Name: reagents, Clostridium difficile toxin PREDICATE DEVICE K923463 - TechLab C. difficile toxin/Antitoxin Kit K081920 - BD Geneohm CDiff Assay INTENDED USE The ProGastroTM Cd Assay is a Real…	Techlab, Inc.	1993	—
*	K081920	BD Geneohm Cdiff Assay Summary page 1 …21 CFR 866.2660 Classification Name: reagents, Clostridium difficile toxin PREDICATE DEVICE K923463 - TechLab C. difficile toxin/Antitoxin Kit K081920 - BD Geneohm CDiff Assay INTENDED USE The ProGastroTM Cd Assay is a Real Time PCR in vitro diagnostic test for the qualitativ…	Bd Diagnostics (Geneohm Sciences, Inc.)	2008	4

Also cleared against K923463: 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 16 years and passes through 3 companies; a new generation was cleared every 15.9 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K923463.

How does its category compare?

All LLH devices

LLH Reagents, Clostridium Difficile Toxin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LLH

1in 2021

2007high 3 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLH

84in 2009

2007high 84 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLH

1in 2021

2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · LLH

1in 2025

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code LLH, 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	1	—	0	0
2008	2	—	0	0
2009	3	84	0	0
2010	1	—	1	1
2011	0	—	0	0
2012	0	—	2	0
2013	0	—	2	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	1	—	1	1
2022	0	—	0	1
2023	0	—	0	1
2024	0	—	0	1
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

The ProGastroTM Cd Assay is a Real Time PCR in vitro diagnostic test for the qualitative detection of toxigenic Clostridium difficile nucleic acids isolated and purified from liquid or soft stool specimens obtained from symptomatic patients. This test targets the Clostridium difficile toxin B gene (tcdB) and is intended for use to aid in the diagnosis of toxigenic Clostridium difficile infections.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090239 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090239: Progastro CD Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090239

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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