# K211342: Sofia 2 Campylobacter FIA

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Nov 23, 2021 after 204 days
- Product code: LQP (Campylobacter Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3110
- 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 K191456 (2019). 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)
- K191456: Campylobacter Quik Chek, Techlab, Inc. (2019) Summary page 4.

## Indications for use
Sofia 2 Campylobacter FIA employs immunofluorescence for the rapid qualitative detection of a Campylobacter-specific antigen in human fecal specimens. Sofia 2 Campylobacter FIA is designed to detect C. jejuni, C. coli, C. lari and C. upsaliensis from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

Source page: https://510kreport.com/device/K211342
Methodology: https://510kreport.com/methodology