# K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform

- Pathway: 510(k) (Traditional)
- Applicant: Sqi Diagnostics Systems
- Decided: Oct 29, 2009 after 378 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
Longest line of descent: 2 generations back to K922830 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983084: Quanta Lite RF Iga Elisa, Inova Diagnostics, Inc. (1998) Summary page 5.
- K971614: Quanta Lite RF Igm, Inova Diagnostics, Inc. (1997) Summary page 5.
- K052264: Quanta Lite CCP3 Igg Elisa, Inova Diagnostics, Inc. (2005) Summary page 5.
- K041658: Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200, Bio-Rad Laboratories, Inc. (2004) Summary page 6.

## Indications for use
The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay and SQiDworksTM Diagnostics Platform is an in vitro diagnostic test system for the qualitative detection of the IgA and IgM classes of Rheumatoid Factors, and the IgG class of anti-cyclic citrullinated peptide antibodies (CCP-proprietary third generation equivalent formulation) in human serum specimens. The IgX PLEXTM Rheumatoid Arthritis Qualitative Assay is intended for use in clinical laboratories as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings, and requires the SQiDworksTM Diagnostics Platform.

Source page: https://510kreport.com/device/K083080
Methodology: https://510kreport.com/methodology