# K193490: SensiTox C. difficile Toxin Test

- Pathway: 510(k) (Traditional)
- Applicant: First Light Diagnostics, Inc.
- Decided: Jul 8, 2021 after 569 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: 1 generation back to K041003 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041003: Immunocard Toxins a & B, Model 712050, Meridian Bioscience, Inc. (2004) Summary page 4.

## Indications for use
The SensiTox C. difficile Toxin Test is an immunofluorescence assay intended for the qualitative detection of Clostridioides difficile toxins A and/or B in human stool specimens. The test is intended as an aid in the diagnosis of C. difficile infection (CDI) in patients exhibiting symptoms of CDI. Negative results do not preclude toxigenic C. difficile infection. The SensiTox C. difficile Toxin Test should not be used as the sole basis for treatment or other management decisions. The test can only be used with the MultiPath platform.

Source page: https://510kreport.com/device/K193490
Methodology: https://510kreport.com/methodology