# K162911: Sofia RSV FIA on Sofia 2 analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Feb 22, 2017 after 128 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- 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: 8 generations back to K882629 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130398: Sofia (R) RSV Fia, Quidel Corp. (2013) Summary page 6.

## Recalls of this device
- Dec 15, 2017 · Class II · Z-1183-2018: The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote pos

## 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. 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 viral culture or an FDA-cleared RSV molecular assay. The Sofia RSV FIA may be used with the Sofia or Sofia 2.

Source page: https://510kreport.com/device/K162911
Methodology: https://510kreport.com/methodology