Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
Device Facts
| Record ID | K163570 |
|---|---|
| Device Name | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) |
| Applicant | Carolina Liquid Chemistries Corporation |
| Product Code | DIO · Clinical Toxicology |
| Decision Date | Aug 15, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K163570 · Aug 15, 2017 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | Carolina Liquid Chemistries Corporation | Patient urine samples | Patient urine samples were used to evaluate the accuracy of the candidate device by comparing results against a reference method (LCMS). | Accuracy study; Patient samples; Method comparison |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Method comparison study | Human urine samples; Sample Size: 100 | LCMS (Reference Method) | Qualitative determination of benzoylecgonine |
Indications for Use
The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is 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 clinical chemistry analyzer. For in vitro diagnostic use only. This 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 in order 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 Cocaine and Cocaine Metabolite Test System (COCM) is a liquid reagent homogeneous enzyme immunoassay; used for qualitative screening of benzoylecgonine in human urine. The system utilizes a competitive binding principle: benzoylecgonine in the sample competes with enzyme-labeled drug (G6PDH-benzoylecgonine) for a fixed amount of anti-benzoylecgonine antibody. In the absence of drug, the antibody binds the enzyme-labeled drug, decreasing enzyme activity. The analyzer measures G6PDH activity spectrophotometrically at 340 nm by monitoring the conversion of NAD+ to NADH. The device is intended for professional use on clinical chemistry analyzers (e.g., CLC480/Biolis 24i). Results are qualitative; positive results are preliminary and require confirmation via GC/MS or LC/MS. The assay aids healthcare providers in identifying potential cocaine use, supporting clinical decision-making when combined with professional judgment.
Clinical Evidence
No clinical studies were performed. Analytical performance was established via bench testing, including precision/reproducibility studies (90 replicates per concentration) and method comparison against LC/MS using 100 human urine specimens. Interference and cross-reactivity were evaluated against various compounds and physiological variables (pH, specific gravity).
Technological Characteristics
Homogenous enzyme immunoassay. Reagents: R1 (mouse monoclonal anti-benzoylecgonine antibody, G6P, NAD, stabilizers, sodium azide); R2 (benzoylecgonine-labeled G6PDH, buffer, sodium azide). Sensing principle: spectrophotometric measurement of NADH production at 340nm. Form factor: liquid, ready-to-use reagents for automated clinical chemistry analyzers. Standards: CLSI EP05-A3, EP07-A2, EP09-A3, EP10-A3.
Indications for Use
Indicated for the qualitative screening of benzoylecgonine (cocaine metabolite) in human urine at a 300 ng/mL cutoff. For professional use in clinical settings. Not for definitive diagnosis; 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).
Predicate Devices
- Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay (k020763)
