# K021384: Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: May 29, 2002 after 27 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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 K903430 (1990). 2 ancestors in all.
2 later devices descend 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)
- K981590: Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con, Bio-Rad (1998) Summary page 1.

## Most influential descendants
- K033404: Liquichek Urine Toxicology Control (Confirmatory Series) (2003), 1 descendant of its own
- K050682: Liquichek Urine Toxicology Control (Level C1) (2005), 0 descendants of its own

## Indications for use
A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

Source page: https://510kreport.com/device/K021384
Methodology: https://510kreport.com/methodology