510(k) · Cleared
Recalled · Class II · 2017Sofia Influenza A+B FIA on Sofia 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quidel Corporation · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Apr 14, 2017 as substantially equivalent to K153012 (Quidel Corporation, 2016) and 2 other predicates after a 226-day review. Its family tree reaches back 2 generations to 2011. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 14, 2017
- Review
- 226 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K112177 (2011). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK112177 Sofia Analyzer and Influenza a+B FiaQuidel Corp. · 2011 · Recalled
- 1 generation backK153012 Sofia Influenza A+B FIAQuidel Corporation · 2016
- This deviceK162438 Sofia Influenza A+B FIA on Sofia 2Quidel Corporation · 2017
- Descendant · cites it directly · 1 of its ownK180288 QuickVue Influenza A+BQuidel Corporation · 2018
- Descendant · cites it directly · 0 of its ownK254262 Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho) · 2026
- Descendant · 2 generations on · 0 of its ownK192719 Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC · 2020
Most influential descendants
Showing 3 of 3 · See all- K180288QuickVue Influenza A+BQuidel Corporation · 2018 · cites it directly1descendant
- K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho) · 2026 · cites it directly0descendants
- K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K112177 | Sofia Analyzer and Influenza a+B Fia | Quidel Corp. | 2011 | 1 |
| −1 | K153012 | Sofia Influenza A+B FIA | Quidel Corporation | 2016 | — |
| 0 (this device) | K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017 | — |
| +1 | K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018 | — |
| +1 | K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 2026 | — |
| +2 | K192719 | Osom Ultra Plus Flu A&B Test Kit | SEKISUI Diagnostics, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PSZ device
- #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153012 | Sofia Influenza A+B FIASummary page 5…II 21 CFR 866.3328 Microbiology KHO - Fluorometer for clinical use 5.7. Predicate Device ® Sofia Influenza A+B FIA on Sofia (K153012, K131606, and K112177) 5.8. Device Description The Sofia Influenza A+B FIA employs immunofluorescence technology that is… | 2016 |
| * | K131606 | Sofia Influenza a+B FiaSummary page 5…II 21 CFR 866.3328 Microbiology KHO - Fluorometer for clinical use 5.7. Predicate Device ® Sofia Influenza A+B FIA on Sofia (K153012, K131606, and K112177) 5.8. Device Description The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with… | 2013 |
| * | K112177 | Sofia Analyzer and Influenza a+B FiaSummary page 5…21 CFR 866.3328 Microbiology KHO - Fluorometer for clinical use 5.7. Predicate Device ® Sofia Influenza A+B FIA on Sofia (K153012, K131606, and K112177) 5.8. Device Description The Sofia Influenza A+B FIA employs immunofluorescence technology that is used with Sofia and So… | 2011 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2017 | Class II | Z-1183-2018 | Software Manufacturing/Software Deployment | 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 possibility that incorrect qualitative… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K180288 (Quidel Corporation, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 2025
MAUDE reports naming product code PSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 7 | 20 | 0 | 0 |
| 2010 | 5 | 29 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 8 | 28 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 27 | 0 | 0 |
| 2016 | 3 | 29 | 0 | 0 |
| 2017 | 3 | 200 | 0 | 0 |
| 2018 | 5 | 28 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 2 | — | 0 | 60 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (278 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162438: Sofia Influenza A+B FIA on Sofia 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162438
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026