# K062929: Quest Diagnostics Urine Cocaine Metabolite Eia

- Pathway: 510(k) (Traditional)
- Applicant: Quest Diagnostics, Inc.
- Decided: Dec 18, 2006 after 81 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933053 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023281: Online Dat II Cocaine II, Roche Diagnostics Corp. (2002) Summary page 1.

## Indications for use
The Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzovlecqonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 np/ml and 150 nq/mI of benzovlecqonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use. The Quest Diagnostics Urine Cocaine Metabolite EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. The Quest Diagnostics Urine Cocaine Metabolite EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Urine Cocaine Metabolite EIA to establish points of reference that are used in the determination of values in the measurement of benzoVlecqonine in urine. The Quest Diagnostics Urine Cocaine Metabolite EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for benzoylecgonine.

Source page: https://510kreport.com/device/K062929
Methodology: https://510kreport.com/methodology