# K132352: Sas Flualert a & B, Sas Influenza a Test

- Pathway: 510(k) (Special)
- Applicant: Sa Scientific, Ltd.
- Decided: Aug 22, 2013 after 24 days
- Product code: GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C)
- Device class: 1
- Regulation: 21 CFR 866.3330
- 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 K991633 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
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) Summary page 1.
- K080380: Sas Influenza a & B Test, Sa Scientific, Inc. (2009) Summary page 4.

## 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 and/or influenza B and should not be used as the sole basis far treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture. SASTM Influenza A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test isnot intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only. Negative results do not preclude infection with influenza A 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/K132352
Methodology: https://510kreport.com/methodology