# K964424: Rotavirus Eia

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech, Inc.
- Decided: Aug 8, 1997 after 276 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 Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants. The performance characteristic was not determined in the elderly population.

Source page: https://510kreport.com/device/K964424
Methodology: https://510kreport.com/methodology