# K153012: Sofia Influenza A+B FIA

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Jan 12, 2016 after 90 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- 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 K112177 (2011). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112177: Sofia Analyzer and Influenza a+B Fia, Quidel Corp. (2011) Summary page 4.
- K131606: Sofia Influenza a+B Fia, Quidel Corp. (2013) Summary page 4.

## Most influential descendants
- K162438: Sofia Influenza A+B FIA on Sofia 2 (2017), 3 descendants of its own
- K180288: QuickVue Influenza A+B (2018), 1 descendant of its own
- K254262: Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA (2026), 0 descendants of its own
- K192719: Osom Ultra Plus Flu A&B Test Kit (2020), 0 descendants of its own

## Indications for use
The Sofia Influenza A +B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash in fresh or transport media specimens from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use. Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A/California/7/2009 (2009 H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 (Victoria-Like) were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine". Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K153012
Methodology: https://510kreport.com/methodology