# K971777: Quantex Aso-CRP-RF Control

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 27, 1997 after 13 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K894486 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894486: Quantex Aso Plus (Latex,Buffer Standard,Control), Biokit USA, Inc. (1989) Summary page 1.
- K896272: Quantex CRP Plus (Latex, Buffer, Standard, Control, Biokit USA, Inc. (1989) Summary page 1.
- K896271: Quantex RF Plus (Latex, Buffer Standard, Control), Biokit USA, Inc. (1989) Summary page 1.

## Most influential descendants
- K984437: Quantex Aso-CRP-RP Control II (1999), 0 descendants of its own

## Indications for use
Biokit’s ASO-CRP-RF control is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.

Source page: https://510kreport.com/device/K971777
Methodology: https://510kreport.com/methodology