# K971585: Immunocard Stat! Rotavirus

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Aug 20, 1997 after 111 days
- Product code: LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus)
- Device class: 1
- Regulation: 21 CFR 866.3405
- Recalls of this device: 1 (0 Class I)
- 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) Premier Rotaclone: named in the summary without a submission number
- (no number) Abbott Test Pack EIA: named in the summary without a submission number

## Recalls of this device
- Jan 25, 2022 · Class II · Z-0678-2022: The product was incorrectly shipped at room temperature rather than refrigerated.

## Indications for use
For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.

Source page: https://510kreport.com/device/K971585
Methodology: https://510kreport.com/methodology