# K051244: Genzyme Osom Influenza a & B Test

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Feb 21, 2006 after 281 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902609 (1990). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031899: Quickvue Influenza a+B Test, Quidel Corp. (2003) Summary page 1.

## Most influential descendants
- K061508: Osom Influenza a&B Test (2006), 2 descendants of its own
- K092633: Osom Influenza a&B Test , Model PN190 (2009), 1 descendant of its own
- K123182: Osom Influenza a&B Test Model 190 (2012), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K051244
Methodology: https://510kreport.com/methodology