# K121794: Liquichek Urine Chemistry Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad, Diagnostics Grp.
- Decided: Jul 11, 2012 after 22 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: 2 generations back to K971954 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020817: Liquichek Urine Chemistry Control, Bio-Rad Laboratories, Inc. (2002) Summary page 1.

## Indications for use
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Amylase; Phosphorus Calcium; Potassium Chloride; Protein, total Creatinine; Sodium Glucose; Urea Nitrogen (BUN) Magnesium; Uric Acid Microalbumin (Albumin)

Source page: https://510kreport.com/device/K121794
Methodology: https://510kreport.com/methodology