# K990627: Autostat II Anti-SS-a/RO Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Diagnotics, Ltd.
- Decided: Apr 28, 1999 after 62 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to SS-A in human serum. The results of the anti-SS-A assay can be used as an aid in the diagnosis of auto-immune diseases including Systemic Lupus Erythematosus (SLE) and Sjégren’s Syndrome (SS). For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K990627
Methodology: https://510kreport.com/methodology