# K994338: Autostat II Rheumatoid Factor Igm Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Diagnotics, Ltd.
- Decided: Feb 3, 2000 after 42 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 2 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 19, 2018 · Class II · Z-2200-2019: Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative
- Feb 21, 2018 · Class II · Z-2134-2019: Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.

## Indications for use
Enzyme Linked Immunosorbent Test for the qualitative and quantitative determination of specific IgM rheumatoid factor (RF) antibodies in human serum. The results of an IgM assay are used in conjunction with other diagnostic tests and clinical investigations. The assay may be used on the [unclear] automated EIA instrument. In vitro diagnostic use only.

Source page: https://510kreport.com/device/K994338
Methodology: https://510kreport.com/methodology