510(k) · Cleared
ClearedOsom Ultra Plus Flu A&B Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SEKISUI Diagnostics, LLC · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Apr 3, 2020 as substantially equivalent to K180288 (Quidel Corporation, 2018) after a 190-day review. Its family tree reaches back 4 generations to 2011.
- Decided
- Apr 3, 2020
- Review
- 190 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K112177 (2011). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK112177 Sofia Analyzer and Influenza a+B FiaQuidel Corp. · 2011 · Recalled
- 3 generations backK153012 Sofia Influenza A+B FIAQuidel Corporation · 2016
- 2 generations backK162438 Sofia Influenza A+B FIA on Sofia 2Quidel Corporation · 2017 · Recalled
- 1 generation backK180288 QuickVue Influenza A+BQuidel Corporation · 2018
- This deviceK192719 Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K112177 | Sofia Analyzer and Influenza a+B Fia | Quidel Corp. | 2011 | 1 |
| −3 | K153012 | Sofia Influenza A+B FIA | Quidel Corporation | 2016 | — |
| −2 | K162438 | Sofia Influenza A+B FIA on Sofia 2 | Quidel Corporation | 2017 | 1 |
| −1 | K180288 | QuickVue Influenza A+B | Quidel Corporation | 2018 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K180288 | QuickVue Influenza A+BSummary page 4…Microbiology (83) Special Conditions for Use Statement: For prescription use 3. Predicate Device Quidel Corp QuickVue® Influenza A+B Test (K180288) 4. Device Description Operating Principle The OSOM® ULTRA PLUS FLU A&B Test consists of a test stick that separately detects… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2020, 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 OSOM® ULTRA PLUS FLU A&B Test is an in vitro rapid diagnostic immunochromatographic assay intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. This test is not intended for the detection of influenza…
Read the full statement (242 words)
The OSOM® ULTRA PLUS FLU A&B Test is an in vitro rapid diagnostic immunochromatographic assay intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.
It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. This test is not intended for the detection of influenza C viruses.
A negative test result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established during the US 2018-2019 influenza season when A/H1N1pdm09 and influenza A/H3N2 were the predominant influenza A viruses in circulation, and the influenza B Yamagata and Victoria lineages were in co-circulation. When other influenza A or B viruses are emerging, performance characteristics may vary.
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. Viral 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/K192719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192719: Osom Ultra Plus Flu A&B Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192719
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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