# K972895: Vidas Rotavirus (RTV) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Oct 3, 1997 after 59 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. The FDA summary names its predicate without a number.
- (no number) Cambridge Biotech Rotaclone Assay: named in the summary without a submission number

## Indications for use
The VIDAS Rotavirus (RTV) assay is for the qualitative detection of rotavirus antigen in stool specimens. It is intended as an aid in the diagnosis of acute nonbacterial gastroenteritis.

Source page: https://510kreport.com/device/K972895
Methodology: https://510kreport.com/methodology