# K061508: Osom Influenza a&B Test

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jun 12, 2006 after 11 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: 5 generations back to K902609 (1990). 7 ancestors in all.
2 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)
- K051244: Genzyme Osom Influenza a & B Test, Genzyme Corp. (2006) Summary page 1.

## Most influential descendants
- 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. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

Source page: https://510kreport.com/device/K061508
Methodology: https://510kreport.com/methodology