# K971614: Quanta Lite RF Igm

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 20, 1997 after 49 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
A semiquantitative enzyme linked immunocassay for use in screening patients for IgM rheumatoid factor (RF) antibodies. Detection of these IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).

Source page: https://510kreport.com/device/K971614
Methodology: https://510kreport.com/methodology