# K033366: Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 12, 2003 after 52 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 K001373 (2000). 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)
- K001373: Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363, Bio-Rad (2000). Our reading of the summary gave K001973, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Liquichek Qualitative Urine Toxicology Control”.

## Most influential descendants
- K052053: Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak (2005), 0 descendants of its own

## Indications for use
Liquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology.

Source page: https://510kreport.com/device/K033366
Methodology: https://510kreport.com/methodology