# K031231: Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 18, 2003 after 61 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: 2 generations back to K890577 (1989). 2 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965171: Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426), Bio-Rad (1997) Summary page 1.

## Most influential descendants
- K070848: Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak, 435,436,437,435X (2007), 6 descendants of its own
- K142391: Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) (2014), 3 descendants of its own
- K182384: ACR  LAB Urine Analysis Test System (2019), 1 descendant of its own
- K103387: Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine Control (2011), 1 descendant of its own
- K042446: Quantify Control and Quantify Plus Controls (2004), 1 descendant of its own

## Indications for use
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in this package insert.

Source page: https://510kreport.com/device/K031231
Methodology: https://510kreport.com/methodology