# K090239: Progastro CD Assay

- Pathway: 510(k) (Traditional)
- Applicant: Prodesse, Inc.
- Decided: Apr 16, 2009 after 73 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923463 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923463: Clostridium Difficile Toxin/Antitoxin Kit, Techlab, Inc. (1993) Summary page 1.
- K081920: BD Geneohm Cdiff Assay, Bd Diagnostics (Geneohm Sciences, Inc.) (2008) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K090239
Methodology: https://510kreport.com/methodology