# K130470: BD Max Cdiff Assay, BD Max Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
- Decided: Apr 2, 2013 after 36 days
- Product code: OZN (C. Difficile Toxin Gene Amplification Assay)
- Device class: 2
- Regulation: 21 CFR 866.3130
- Recalls of this device: 2 (0 Class I)
- 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.
10 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081920: BD Geneohm Cdiff Assay, Bd Diagnostics (Geneohm Sciences, Inc.) (2008) Summary page 1.

## Most influential descendants
- K142422: cobas Cdiff Test (2015), 5 descendants of its own
- K171770: cobas Cdiff Nucleic acid test for use on the cobas Liat System (2017), 4 descendants of its own
- K212427: cobas Cdiff nucleic acid test for use on the cobas Liat System (2021), 2 descendants of its own
- K172569: GenePOC CDiff (2017), 1 descendant of its own
- K260045: cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) (2026), 0 descendants of its own

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0238-2026: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is 
- Oct 31, 2024 · Class II · Z-0590-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 

## Indications for use
The BD MAX™ Cdiff Assay performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having C. difficile infection (CDI). The test, performed directly on the specimen, utilizes real-time polymerase chain reaction (PCR) for the amplification of C. difficile toxin B gene DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ Cdiff Assay is intended to aid in the diagnosis of CDI.

Source page: https://510kreport.com/device/K130470
Methodology: https://510kreport.com/methodology