# K213211: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Liquid Chemistries Corp.
- Decided: Jan 27, 2022 after 120 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: 2 generations back to K960187 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020763: Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit), Lin-Zhi International, Inc. (2002) Summary page 4.

## Indications for use
The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is intended for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a Carolina Liquid Chemistries CLC6410 automated clinical chemistry analyzer. For in vitro diagnostic use only. The assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Source page: https://510kreport.com/device/K213211
Methodology: https://510kreport.com/methodology