# K162438: Sofia Influenza A+B FIA on Sofia 2

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Apr 14, 2017 after 226 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: 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 K112177 (2011). 3 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K153012: Sofia Influenza A+B FIA, Quidel Corporation (2016) Summary page 5.
- K131606: Sofia Influenza a+B Fia, Quidel Corp. (2013) Summary page 5.
- K112177: Sofia Analyzer and Influenza a+B Fia, Quidel Corp. (2011) Summary page 5.

## Most influential descendants
- 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

## 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 Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimens in transport media 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 viral 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 patient management decisions. This test is intended for professional and laboratory use. The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2. 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, samples should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture samples.

Source page: https://510kreport.com/device/K162438
Methodology: https://510kreport.com/methodology