# K052053: Liquichek Qualitative Urine Toxicology Control, Negative, Positive, Minipak

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Aug 9, 2005 after 11 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 K001373 (2000). 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)
- K033366: Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455, Bio-Rad (2003) Summary page 1.
- 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”.

## 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/K052053
Methodology: https://510kreport.com/methodology