# K033924: Liquichek Urine Toxicology Control (Screen Series)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Feb 3, 2004 after 47 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 K021411 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021411: Liquichek Urine Toxicology Control Level S1, S2 & S3 Models 461, 462 & 463, Bio-Rad (2002) Summary page 1.

## Most influential descendants
- K120504: Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak (2012), 0 descendants of its own

## Indications for use
Levels S1, S2, S3, S1 Low Opiate, and S2 Low Opiate Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures. Levels S1 E, S2E, S1 E Low Opiate and S2E Low Opiate Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology enzyme immunoassay (EIA) screening procedures.

Source page: https://510kreport.com/device/K033924
Methodology: https://510kreport.com/methodology