# K062123: Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat Performance Verifiers I, II, Iii, IV

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 16, 2006 after 114 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993988 (2000). 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)
- K031512: Emit II Plus Cocaine Metabolite Assay, Dade Behring, Inc. (2003) Summary page 2.
- K022707: Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439, Bio-Rad (2002) Summary page 2.

## Recalls of this device
- Oct 4, 2013 · Class II · Z-0817-2014: Inaccurate quality control results.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products COCM Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of either a 150 ng/mL or a 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose. The VITROS Chemistry Products COCM assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse. For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems. For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K062123
Methodology: https://510kreport.com/methodology