# K021414: Liquichek Urine Toxicology Control Level S1 Low Opiate & S2 Low Opiate Models 466 & 467

- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K992812: Liquichek™ Urine Toxicology Control. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K992809: Liquichek™ Urine Toxicology Control. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

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

Source page: https://510kreport.com/device/K021414
Methodology: https://510kreport.com/methodology