# K971954: Liquichek Urine Chemistry Control (Cat.NO. 397,398)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 11, 1997 after 14 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
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Human Urine Control: named in the summary without a submission number

## Most influential descendants
- K020817: Liquichek Urine Chemistry Control (2002), 19 descendants of its own
- K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H (2007), 11 descendants of its own
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP (2007), 3 descendants of its own
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H (2008), 2 descendants of its own

## 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.

Source page: https://510kreport.com/device/K971954
Methodology: https://510kreport.com/methodology