# K163713: Sofia Lyme FIA, Sofia Lyme Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Oct 20, 2017 after 294 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: 3 generations back to K894224 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122979: Vidas Lyme Igm, Biomerieux S.A. (2013) Summary page 6.
- K122986: Vidas Lyme Igg, Biomerieux S.A. (2013) Summary page 6.

## 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 the diagnosis of Lyme disease. A negative result does not preclude infection with B. burgdorferi. All positive results for IgM and/or IgG 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 Control Set is intended for use as assayed quality control materials to verify the performance of the Sofia Lyme FIA test system.

Source page: https://510kreport.com/device/K163713
Methodology: https://510kreport.com/methodology