# K080380: Sas Influenza a & B Test

- Pathway: 510(k) (Traditional)
- Applicant: Sa Scientific, Inc.
- Decided: Jul 23, 2009 after 526 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: 3 generations back to K991633 (1999). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041441: Sas Influenza a Test, Sa Scientific, Inc. (2004). Our OCR of the scanned summary read K044141, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SAS Influenza A Test”.
- K041439: Sas Influenza B Test, Sa Scientific, Inc. (2004) Summary page 1.

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

## Indications for use
SASTM FluAlert A & B Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only. Negative results do not preclude infection with influenza A or influenza B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

Source page: https://510kreport.com/device/K080380
Methodology: https://510kreport.com/methodology