# K182747: EliA RF IgM Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Dec 18, 2018 after 81 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971614 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102673: Rheumatoid Factor Immunological Test System, Phadia US, Inc. (2011) Summary page 6.

## Recalls of this device
- May 10, 2019 · Class II · Z-1907-2019: Potential for reporting low assay results

## Indications for use
EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 2500/5000.

Source page: https://510kreport.com/device/K182747
Methodology: https://510kreport.com/methodology