# K993557: Autostat II Rheumatoid Factor Iga Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Diagnotics, Ltd.
- Decided: Mar 3, 2000 after 135 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- 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 IgA rheumatoid factor (RF) antibodies in human serum. Uses: The results of the RF IgA assay can be used as an aid in the diagnosis of rheumatoid arthritis (RA) when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay may be used on the Hycor HyeTec Automated EIA instrument. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K993557
Methodology: https://510kreport.com/methodology