510(k) · Cleared
ClearedOsom Influenza a&B Test Model 190
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SEKISUI Diagnostics, LLC · GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Cleared on Nov 5, 2012 as substantially equivalent to K092633 (Genzyme Corporation, 2009) after a 26-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Nov 5, 2012
- Review
- 26 days
- Class
- Class I
- Product code
- GNX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K902609 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 6 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 5 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 4 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 3 generations backK051244 Genzyme Osom Influenza a & B TestGenzyme Corp. · 2006
- 2 generations backK061508 Osom Influenza a&B TestGenzyme Corp. · 2006
- 1 generation backK092633 Osom Influenza a&B Test , Model PN190Genzyme Corporation · 2009
- This deviceK123182 Osom Influenza a&B Test Model 190SEKISUI Diagnostics, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −6 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −5 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −4 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −3 | K051244 | Genzyme Osom Influenza a & B Test | Genzyme Corp. | 2006 | — |
| −2 | K061508 | Osom Influenza a&B Test | Genzyme Corp. | 2006 | — |
| −1 | K092633 | Osom Influenza a&B Test , Model PN190 | Genzyme Corporation | 2009 | — |
| 0 (this device) | K123182 | Osom Influenza a&B Test Model 190 | SEKISUI Diagnostics, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 GNX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K092633 | Osom Influenza a&B Test , Model PN190Summary page 2…&B estOSOM® Influenza A&B Test Charcterstis Charcterstis OSM® nflunzaA&B est(K092633) The OSOM® Influenza A&B Test is an The OSOMO Influenza A&B Test is an Intended Use… | 2009 |
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 22 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All GNX devicesGNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GNX
6in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GNX
27in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GNX
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GNX
93in 2025
MAUDE reports naming product code GNX, 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 | 0 | — | 4 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 6 | 27 | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 36 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 93 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OSOM® Influenza A&B Test is an in vitro diagnostic Immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections.
This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123182: Osom Influenza a&B Test Model 190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123182
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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