# K041439: Sas Influenza B Test

- Pathway: 510(k) (Traditional)
- Applicant: Sa Scientific, Inc.
- Decided: Jul 22, 2004 after 51 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: 2 generations back to K991633 (1999). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021649: Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack, Binax, Inc. (2002) Summary page 1.

## Most influential descendants
- K080380: Sas Influenza a & B Test (2009), 1 descendant of its own
- K132352: Sas Flualert a & B, Sas Influenza a Test (2013), 0 descendants of its own

## Indications for use
SAS™ Influenza B Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type B antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type A or C viral antigen. The test is for professional use.

Source page: https://510kreport.com/device/K041439
Methodology: https://510kreport.com/methodology