# K093577: Liquichek Opiate Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Mar 12, 2010 after 114 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 2.

## Indications for use
Liquichek Opiate Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

Source page: https://510kreport.com/device/K093577
Methodology: https://510kreport.com/methodology