# K983084: Quanta Lite RF Iga Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Nov 4, 1998 after 62 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.
3 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102673: Rheumatoid Factor Immunological Test System (2011), 1 descendant of its own
- K182747: EliA RF IgM Immunoassay (2018), 0 descendants of its own
- K083080: Igx Plex Rheumatoid Arthritis (RA) Assay and Sqidworks Diagnostics Platform (2009), 0 descendants of its own

## Indications for use
The QUANTA Lite™ RF IgA ELISA is a semiquantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgA rheumatoid factor (RF) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA).

Source page: https://510kreport.com/device/K983084
Methodology: https://510kreport.com/methodology