# K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Aug 22, 2002 after 8 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.
11 later devices descend from it; 10 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K991558: Liquichek Urine Toxicology Control Levels S1 and S2. 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.

## Most influential descendants
- K062077: Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers (2006), 1 descendant of its own
- K143500: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set (2015), 0 descendants of its own
- K093577: Liquichek Opiate Control (2010), 0 descendants of its own
- K062165: Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers (2007), 0 descendants of its own
- K063164: Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, Iii, IV (2006), 0 descendants of its own

## Indications for use
LiquichekTM Urine Toxicology Control Levels S1E and S2E 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/K022707
Methodology: https://510kreport.com/methodology