510(k) · Cleared
ClearedSofia Influenza A+B FIA
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 Jan 12, 2016 as substantially equivalent to K112177 (Quidel Corp., 2011) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2011. 4 later devices descend from it.
- Decided
- Jan 12, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K112177 (2011). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK112177 Sofia Analyzer and Influenza a+B FiaQuidel Corp. · 2011 · Recalled
- This deviceK153012 Sofia Influenza A+B FIAQuidel Corporation · 2016
- Descendant · cites it directly · 3 of its ownK162438 Sofia Influenza A+B FIA on Sofia 2Quidel Corporation · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK180288 QuickVue Influenza A+BQuidel Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK254262 Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho) · 2026
- Descendant · 3 generations on · 0 of its ownK192719 Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation · 2017 · cites it directly3descendants
- K180288QuickVue Influenza A+BQuidel Corporation · 2018 · 2 generations on1descendant
- K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho) · 2026 · 2 generations on0descendants
- K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112177 | Sofia Analyzer and Influenza a+B Fia | Quidel Corp. | 2011 | 1 |
| 0 (this device) | K153012 | Sofia Influenza A+B FIA | Quidel Corporation | 2016 | — |
| +1 | K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017 | 1 |
| +2 | K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018 | — |
| +2 | K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K112177 | Sofia Analyzer and Influenza a+B FiaSummary page 4…5.4. Device Trade Name: Sofia® Influenza A+B FIA 5.5. Common Name: Influenza A+B immunological test system 5.6. Predicate Device: Sofia Influenza A+B FIA (K112177 and K131606) 5.7. Device Classification/Name: 21 CFR 866.3330 / Influenza virus serological reagents Influenza virus serolo… | 2011 |
| * | K131606 | Sofia Influenza a+B FiaSummary page 4…ice Trade Name: Sofia® Influenza A+B FIA 5.5. Common Name: Influenza A+B immunological test system 5.6. Predicate Device: Sofia Influenza A+B FIA (K112177 and K131606) 5.7. Device Classification/Name: 21 CFR 866.3330 / Influenza virus serological reagents Influenza virus serological reagen… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162438 | Sofia Influenza A+B FIA on Sofia 2 | 2017 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2016, 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 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…
Read the full statement (259 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153012 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153012: Sofia Influenza A+B FIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153012
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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