# K171976: Sofia Strep A+ FIA, Sofia 2 Analyzer

- Pathway: 510(k) (Dual Track)
- Applicant: Quidel Corporation
- Decided: Dec 21, 2017 after 174 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- 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 K011097 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141775: Sofia (R) Strep a+ Fia, Quidel Corporation (2014) Summary page 7.

## Indications for use
The Sofia Strep A+ FIA detects Group A Streptococcal antigens from throat swabs from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection. The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.

Source page: https://510kreport.com/device/K171976
Methodology: https://510kreport.com/methodology