# K965171: Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 13, 1997 after 20 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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 K890577 (1989). 1 ancestor in all.
10 later devices descend from it; 2 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)
- K890577: Kenlor Liquid Urine Control, Kenlor Industries, Inc. (1989) Summary page 1.

## Most influential descendants
- K031231: Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis (2003), 9 descendants of its own
- 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

## Indications for use
Liquichek Urinalysis Control is intended for use as an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K965171
Methodology: https://510kreport.com/methodology