# K042446: Quantify Control and Quantify Plus Controls

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Nov 2, 2004 after 54 days
- Product code: JJW (Urinalysis 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: 3 generations back to K890577 (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)
- K031231: Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis, Bio-Rad (2003) Summary page 1.

## Most influential descendants
- K050328: Pregnancy-Skreen (2005), 0 descendants of its own

## Indications for use
qUAntify® Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert. qUAntify® Plus Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K042446
Methodology: https://510kreport.com/methodology