# K141775: Sofia (R) Strep a+ Fia

- Pathway: 510(k) (Dual Track)
- Applicant: Quidel Corporation
- Decided: Dec 16, 2014 after 168 days
- Product code: GTY (Antigens, All Groups, Streptococcus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011097 (2001). 3 ancestors in all.
1 later device descends 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)
- K123793: Sofia Strep a Fia, Quidel Corporation (2013) Summary page 5.

## Most influential descendants
- K171976: Sofia Strep A+ FIA, Sofia 2 Analyzer (2017), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1598-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## 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 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/K141775
Methodology: https://510kreport.com/methodology