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

K213211 · Carolina Liquid Chemistries Corp. · DIO · Jan 27, 2022 · Clinical Toxicology

Device Facts

• Record ID: K213211
• Device Name: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
• Applicant: Carolina Liquid Chemistries Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jan 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Indications for Use

The Carolina Liquid Chemistries 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.

Device Story

The Carolina Liquid Chemistries COCM Test System is a liquid, ready-to-use homogeneous enzyme immunoassay for qualitative detection of benzoylecgonine in human urine. It utilizes a competitive binding mechanism: benzoylecgonine in the sample competes with G6PDH-labeled benzoylecgonine for a fixed amount of mouse monoclonal anti-benzoylecgonine antibody. In the absence of drug, antibody binds the labeled enzyme, inhibiting activity; when drug is present, it binds the antibody, leaving the labeled enzyme free to convert NAD+ to NADH. This reaction is measured spectrophotometrically at 340 nm on the CLC6410 automated clinical chemistry analyzer. Used by trained professionals in clinical laboratories to provide rapid preliminary screening for cocaine use. Results are intended to guide clinical decision-making, necessitating follow-up with a more specific confirmatory method like GC/MS or LC/MS. The device benefits patients by providing a rapid, automated screening tool for drug abuse monitoring.

Clinical Evidence

Bench testing only. Accuracy study performed on 81 clinical urine samples (41 LC/MS confirmed negative, 40 LC/MS confirmed positive) compared to the 300 ng/mL cutoff. Results showed 100% agreement among positives and 100% agreement among negatives. Precision, specificity, interference (pH and specific gravity), and carryover studies demonstrated acceptable performance.

Technological Characteristics

Homogeneous enzyme immunoassay; liquid, ready-to-use reagents. Sensing principle: spectrophotometric measurement of G6PDH enzyme activity at 340 nm. Analyte: benzoylecgonine. Antibody: mouse monoclonal anti-benzoylecgonine. Storage: 2-8°C. Platform: CLC6410 automated clinical chemistry analyzer.

Indications for Use

Indicated for qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at 300 ng/mL cutoff. For professional use in clinical settings. Not for self-testing. Preliminary screening only; requires confirmatory testing via GC/MS or LC/MS.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION MEMORANDUM

510(k) Number: k213211

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.