# K021415: Liquichek Urine Toxicology Control Level C2 Low Opiate & C3 Low Opiate Models 468 & 469

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: May 29, 2002 after 26 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.
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)
- K981590: Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con, Bio-Rad (1998) Summary page 1.

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

Source page: https://510kreport.com/device/K021415
Methodology: https://510kreport.com/methodology