# K990842: Sas Rota Test

- Pathway: 510(k) (Traditional)
- Applicant: Sa Scientific, Inc.
- Decided: Aug 9, 1999 after 147 days
- Product code: LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus)
- Device class: 1
- Regulation: 21 CFR 866.3405
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SAS™ Rota Test is a rapid, membrane-based immunogold assay for the qualitative detection of Rotavirus antigens in feces as an aid in the diagnosis of acute gastroenteritis caused by rotavirus infection. This test is for professional use only.

Source page: https://510kreport.com/device/K990842
Methodology: https://510kreport.com/methodology