# K042865: Liquichek Urine Toxicology Control, (Levels S1S and S2S)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Nov 24, 2004 after 37 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: 1 generation back to K022707 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439, Bio-Rad (2002) Summary page 1.

## Indications for use
Liquichek Urine Toxicology Control is intended for use as quality control urine to monitor the performance of laboratory urine toxicology enzyme Immunoassay (EIA) screening procedures.

Source page: https://510kreport.com/device/K042865
Methodology: https://510kreport.com/methodology