# K123793: Sofia Strep a Fia

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Jun 17, 2013 after 189 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: 1 generation back to K011097 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011097: Quickvue Dipstick Strep a, Quidel Corp. (2001)
- K112177: Sofia Analyzer and Influenza a+B Fia, Quidel Corp. (2011) Summary page 1.

## Most influential descendants
- K141775: Sofia (R) Strep a+ Fia (2014), 1 descendant of its own
- K171976: Sofia Strep A+ FIA, Sofia 2 Analyzer (2017), 0 descendants of its own

## Indications for use
The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. All negative test results should be confirmed by bacterial culture 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.

Source page: https://510kreport.com/device/K123793
Methodology: https://510kreport.com/methodology