# K254295: Sofia Lyme FIA; Sofia 2 Campylobacter FIA

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
- Decided: Jul 10, 2026 after 191 days
- Product code: LSR (Reagent, Borrelia Serological Reagent)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894224 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173691: Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack, Quidel Corporation (2018) Summary page 7.
- (no number) Sofia 2 Campylobacter FIA: named in the summary without a submission number

## Indications for use
The Sofia Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection. This qualitative test is intended for use as an aid in diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. All positive results for IgM and/or 1gG should be further tested by a corresponding second-tier western blot assay. Test results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures. The Sofia Lyme FIA may be used with Sofia or Sofia 2. 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/K254295
Methodology: https://510kreport.com/methodology