# K973464: Quantex RF Plus (Latex, Buffer, Standard, Control)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Oct 22, 1997 after 40 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: 1 generation back to K896271 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896271: Quantex RF Plus (Latex, Buffer Standard, Control), Biokit USA, Inc. (1989) Summary page 1.

## Indications for use
quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic test for use with automated instrumentation in the quantitative determination of human rheumatoid factors in serum by turbidimetric itmunoassay and is intended as an aid in the diagnosis of rheumatoid arthritis.

Source page: https://510kreport.com/device/K973464
Methodology: https://510kreport.com/methodology