510(k) · Cleared
ClearedOsom 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 Jun 12, 2006 as substantially equivalent to K051244 (Genzyme Corp., 2006) after an 11-day review. Its family tree reaches back 5 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 12, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902609 (1990). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 4 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 3 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 2 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 1 generation backK051244 Genzyme Osom Influenza a & B TestGenzyme Corp. · 2006
- This deviceK061508 Osom Influenza a&B TestGenzyme Corp. · 2006
- Descendant · cites it directly · 1 of its ownK092633 Osom Influenza a&B Test , Model PN190Genzyme Corporation · 2009
- Descendant · 2 generations on · 0 of its ownK123182 Osom Influenza a&B Test Model 190SEKISUI Diagnostics, LLC · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −4 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −3 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −2 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −1 | K051244 | Genzyme Osom Influenza a & B Test | Genzyme Corp. | 2006 | — |
| 0 (this device) | K061508 | Osom Influenza a&B Test | Genzyme Corp. | 2006 | — |
| +1 | K092633 | Osom Influenza a&B Test , Model PN190 | Genzyme Corporation | 2009 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051244 | Genzyme Osom Influenza a & B TestSummary page 1…ice Trade or Proprietary Name: OSOM Influenza A&B Test 5. Legally Marketed Devices to which Equivalence is Being Claimed: OSOM Influenza A&B Test (K 051244) Page 3 === Page 2… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092633 | Osom Influenza a&B Test , Model PN190 | 2009 | 1 |
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 2.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K092633 (Genzyme Corporation, 2009) 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.
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. 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/K061508 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061508: Osom Influenza a&B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061508
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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