# K100227: Sas Flualert a&B, Sas Influenza a Test

- Pathway: 510(k) (Special)
- Applicant: Sa Scientific, Inc.
- Decided: Feb 23, 2010 after 28 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SAS FluAlert A Test: named in the summary without a submission number

## Indications for use
SASTM FluAlert 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 is not 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/K100227
Methodology: https://510kreport.com/methodology