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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.

Carolina Liquid Chemistries Cocaine Metabolite Test System (COCM) is a ready-to-use, liquid reagent, homogenous enzyme immunoassay. The assay uses a specific antibody that can detect benzoylecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine and glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of the specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically and 340nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

This document describes the validation of the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM), an enzyme immunoassay for the qualitative detection of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The study aims to demonstrate substantial equivalence to a legally marketed predicate device (Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay).

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document implicitly uses the performance of the predicate device and LCMS/GCMS as the "acceptance criteria" for demonstrating substantial equivalence. The key performance characteristics evaluated for the candidate device are Accuracy, Interfering Substances/Cross-Reactivity, and Precision.

- Drug Free (0.00 ng/mL): 30 Negative (100% negative)
-  50 to  100 to  150% of cutoff (>= 450 ng/mL): 26 Positive (100% positive)
- Overall: All 100 samples matched LCMS results (100% agreement). |

| Interfering Substances/Cross-Reactivity/Specificity | Demonstrate a specific antibody that can detect benzoylecgonine with minimal cross-reactivity to various common prescription and abused drugs. pH (3-11) and specific gravity (1.000-1.030) should not interfere. | - Specific Gravity & pH: "Study results show that neither pH (range tested: 3-11), nor specific gravity conditions (range tested 1.000-1.030) will interfere with this assay."

• Specificity (Cross-Reactivity):
  • Structurally Related Cocaine Compounds showed cross-reactivity (e.g., Cocaine (30 µg/mL), Norcocaine (60 µg/mL), Ecgonine, Methyl Ester (350 µg/mL) were "Positive"). Benzoylecgonine (0.3 µg/mL) also positive, as expected.
  • Numerous other common drugs/substances (e.g., Acetaminophen, Amphetamine, Codeine, Morphine, Nicotine, etc.) tested up to 1000-2000 µg/mL showed "Negative" cross-reactivity. |
    | Precision | Consistent and reproducible results across runs and within runs, especially around the cutoff concentration. | - Within Run (Qualitative Analysis): 20 replicates of spiked human urine at 9 concentrations. At the 300 ng/mL cutoff, 15 Negative / 5 Positive results were obtained (implies some borderline results). All other concentrations (0-225 ng/mL and 375-600 ng/mL) showed 100% agreement with expected negative/positive results.
• Run-to-Run (Qualitative Analysis): 90 replicates of spiked human urine at 9 concentrations. At the 300 ng/mL cutoff, 84 Positive / 6 Negative results were obtained (implies some borderline results). All other concentrations (0-225 ng/mL and 375-600 ng/mL) showed 100% agreement with expected negative/positive results.
• Within/Run-to-Run (ΔmA/min): Provided mean, SD, %CV for different concentrations, indicating good precision (e.g., %CV

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