# K102673: Rheumatoid Factor Immunological Test System

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Sep 30, 2011 after 379 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: 1 generation back to K971614 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971614: Quanta Lite RF Igm, Inova Diagnostics, Inc. (1997) Summary page 2.
- K983084: Quanta Lite RF Iga Elisa, Inova Diagnostics, Inc. (1998) Summary page 2.

## Most influential descendants
- K182747: EliA RF IgM Immunoassay (2018), 0 descendants of its own

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

## Indications for use
EliA RF 1gM is intended for the in vitro semni-quantitative measurement of 1gM class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF 1gM uses the EliA 1gM method on the instruments Phadia 100 and Phadia 250. EliA RF IgA is intended for the in vitro semni-quantitative measurement of IgA class rheumatoid factor antibodies in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250. EliA RE Positive Control 100 is intended for laboratory use in monitoring the Performance of in vitro measurement of rheumatoid factor (RE) with Phadia 100 using the EliA 1gM or IgA method. EliA RE Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of rheumatoid factor (RF) with Phadia 250 using the EliA 1gM or IgA method.

Source page: https://510kreport.com/device/K102673
Methodology: https://510kreport.com/methodology