# K130398: Sofia (R) RSV Fia

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Aug 13, 2013 after 175 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K882629 (1988). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121633: BD Veritor (TM) System for the Rapid Detection of RSV, Becton, Dickinson and Company (2012) Summary page 1.

## Most influential descendants
- K162911: Sofia RSV FIA on Sofia 2 analyzer (2017), 0 descendants of its own

## Indications for use
The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients less than 19 years of age. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by virus culture or an FDA-cleared RSV molecular assay.

Source page: https://510kreport.com/device/K130398
Methodology: https://510kreport.com/methodology