510(k) · Cleared
ClearedGenzyme Osom Influenza a & B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genzyme Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Feb 21, 2006 as substantially equivalent to K031899 (Quidel Corp., 2003) after a 281-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Feb 21, 2006
- Review
- 281 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902609 (1990). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 3 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 2 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 1 generation backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- This deviceK051244 Genzyme Osom Influenza a & B TestGenzyme Corp. · 2006
- Descendant · cites it directly · 2 of its ownK061508 Osom Influenza a&B TestGenzyme Corp. · 2006
- Descendant · 2 generations on · 1 of its ownK092633 Osom Influenza a&B Test , Model PN190Genzyme Corporation · 2009
- Descendant · 3 generations on · 0 of its ownK123182 Osom Influenza a&B Test Model 190SEKISUI Diagnostics, LLC · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −3 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −2 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −1 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| 0 (this device) | K051244 | Genzyme Osom Influenza a & B Test | Genzyme Corp. | 2006 | — |
| +1 | K061508 | Osom Influenza a&B Test | Genzyme Corp. | 2006 | — |
| +2 | K092633 | Osom Influenza a&B Test , Model PN190 | Genzyme Corporation | 2009 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K031899 | Quickvue Influenza a+B TestSummary page 1…or Proprietary Name: OSOM Influenza A&B Test 5. Legally Marketed Devices to which Equivalence is Being Claimed: Quidel QuickVuieR Influenza A±B Test (K 031899) genzyme OSOM Influenza A&B Test… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061508 | Osom Influenza a&B Test | 2006 | 2 |
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 16 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K061508 (Genzyme Corp., 2006) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K031899.
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.
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 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.
Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051244: Genzyme Osom Influenza a & B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051244
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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