← Product Code [DIO](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO) · K163570

# Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (K163570)

_Carolina Liquid Chemistries Corporation · DIO · Aug 15, 2017 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO/K163570

## Device Facts

- **Applicant:** Carolina Liquid Chemistries Corporation
- **Product Code:** [DIO](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO.md)
- **Decision Date:** Aug 15, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3250
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## 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.

## Regulatory 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)

## Submission Summary (Full Text)

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>
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k163570

B. Purpose for Submission:
New device

C. Measurand:
Cocaine and cocaine metabolites

D. Type of Test:
Qualitative Homogeneous Enzyme Immunoassay

E. Applicant:
Carolina Liquid Chemistries Corporation

F. Proprietary and Established Names:
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)

G. Regulatory Information:
1. Regulation section:
21 CFR §862.3250, Cocaine and Cocaine Metabolite Test System
2. Classification:
Class II
3. Product code:
DIO – Enzyme Immunoassay, Cocaine and Cocaine Metabolites
4. Panel:
Toxicology (91)

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H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) 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.

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Performance characteristics were determined using the CLC480/Biolis 24i Clinical Chemistry Analyzer.

I. Device Description:

The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is a ready-to-use, liquid reagent homogeneous enzyme immunoassay for qualitatively determining the presence of cocaine metabolite (benzoylecgonine) in human urine. The COCM R1 Antibody/Substrate Reagent contains mouse monoclonal anti-benzoylecgonine antibody, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide as preservative, and the COCM R2, Enzyme-Drug Conjugate Reagent contains benzoylecgonine-labeled glucose-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide as preservative.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay

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2. Predicate 510(k) number(s):

k020763

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Candidate Device: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) (k163570) | Predicate Device: Enzyme Immunoassay, Cocaine and Cocaine Metabolites (k020763)  |
|  Intended Use | It is intended for the qualitative determination of Benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff value of 300ng/ml. | It is intended for the qualitative and semiquantitative determination of Benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff value of 300ng/ml.  |
|  Method | Same | Enzyme Immunoassay  |
|  Reagent Composition | Same | ■ Antibody/Substrate Reagent {R1}: Contains mouse monoclonal antibenzoylecgonine antibody, glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide {NAD), stabilizers, and sodium azide as preservative. ■ Enzyme-drug Conjugate Reagent {R2}: Contains benzoylecgonine-labeled glucose-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide as preservative.  |
|  Sample type | Same | Urine  |
|  Cutoff | Same | 300 ng/ml  |

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|  Differences  |   |   |
| --- | --- | --- |
|  Item | Candidate Device: Cocaine Metabolite Enzyme Immunoassay (COCM) (k163570) | Predicate Device: Enzyme Immunoassay, Cocaine and Cocaine Metabolites (k020763)  |
|  Results mode | Qualitative only | Qualitative and semi-quantitative  |

K. Standard/Guidance Document Referenced (if applicable):

CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Procedures; Approved Guideline-Third Edition

CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition

CLSI EP17-A2: Evaluation of Detection Capability for clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition.

CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition

L. Test Principle:

The assay is based on competition between benzoylecgonine labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) and free drug from the urine sample, for a fixed amount of antibody. In the absence of free drug from the urine sample, the specific antibody binds to the drug labeled with G6PDH causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD+) to NADH.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

To evaluate device precision, samples were prepared from negative urine samples spiked to nine different concentrations (cutoff, and ±25%, ±50%, ±75%, and ±100% of the cut off concentration 300 ng/dL) and were analyzed in duplicate, twice per day for 22.5 days to obtain a total of 90 replicates per concentration. Results are summarized below.

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|  Concentration (ng/mL) | % of cutoff | Result  |
| --- | --- | --- |
|  0 | -100 | 90 Negative  |
|  75 | -75 | 90 Negative  |
|  150 | -50 | 90 Negative  |
|  225 | -25 | 90 Negative  |
|  300 | Cutoff | 6 Negative / 84Positive  |
|  375 | +25 | 90 Positive  |
|  450 | +50 | 90 Positive  |
|  525 | +75 | 90 Positive  |
|  600 | +100 | 90 Positive  |

b. Linearity/assay reportable range:

Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

DRI Multi-Drug Calibrators were previously cleared under k983159.

d. Detection limit:

Not applicable.

e. Analytical specificity:

Interference and cross-reactivity studies were previously evaluated in k020763 and the results are summarized below.

|  Compound | Concentration Tested (μg/mL) | Cross-reactivity (%)  |
| --- | --- | --- |
|  Acetaminophen | 1500 | Negative  |
|  Acetylsalicylic acid | 1500 | Negative  |
|  Amobarbital | 1000 | Negative  |
|  Amphetamine | 1000 | Negative  |
|  Burpropion | 1000 | Negative  |
|  Caffeine | 1000 | Negative  |
|  Codeine | 1000 | Negative  |
|  Chlorpheniramine | 1000 | Negative  |
|  Chorpromzaine | 1000 | Negative  |
|  Dextromethorphan | 1000 | Negative  |
|  Ecgonine | 1000 | Negative  |
|  Lidocaine | 1000 | Negative  |
|  Meperidine | 1000 | Negative  |

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|  Compound | Concentration Tested (μg/mL) | Cross-reactivity (%)  |
| --- | --- | --- |
|  Methadone | 1000 | Negative  |
|  Morphine | 2000 | Negative  |
|  Nicotine | 1000 | Negative  |
|  Lorazepam | 1000 | Negative  |
|  Phencyclidine | 1000 | Negative  |
|  Phenobarbital | 1000 | Negative  |
|  Propoxyphene | 1000 | Negative  |
|  Ranitidine | 1000 | Negative  |
|  Secobarbital | 1000 | Negative  |
|  Methamphetamine | 1000 | Negative  |
|  Methaqualone | 1000 | Negative  |
|  Valproic Acid | 1000 | Negative  |

Results of the cross reactivity studies are summarized below.

|  Structurally Related Cocaine Compounds  |   |   |
| --- | --- | --- |
|  Compound | Concentration (μg/mL) | Cross-reactivity  |
|  Benzoylecgonine | 0.3 | Positive  |
|  Cocaine | 30 | Positive  |
|  Norocaine | 60 | Positive  |
|  Ecgonine, Methyl | 350 | Positive  |

Effect of pH:

To evaluate the effect of urine pH on device performance, negative urine samples with pH ranging from 3.00 to 11.00 (in increments of 1 pH unit) were spiked with benzoylecgonine to ±25% of the device cutoff. The pH ranges tested did not affect the results from the device.

Effect of specific gravity:

To evaluate the effect of urine specific gravity on device performance, negative urine samples with specific gravities ranging from 1.000-1.030 were spiked with benzoylecgonine to ±25% of the device cutoff. The specific gravity ranges tested did not affect the results from the device.

f. Assay cut-off:

Refer to section M.1.a. above.

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2. Comparison studies:

a. Method comparison with predicate device:

A total of 100 human urine specimens were quantitated for benzoylecgonine by liquid chromatography/mass spectrometry (LC/MS) and these results were compared to the qualitative results obtained with the Carolina Liquid Chemistry Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM). Results from this analysis are summarized in the following table.

|  Results | Drug-free | Low negative (<-50% of cutoff) | Near cut off negative (between -50% of cutoff and cutoff ) | Near cut off Positive (between cutoff and +50% of cutoff ) | High Positive (>+50% of the cutoff )  |
| --- | --- | --- | --- | --- | --- |
|  Positive | 0 | 0 | 0 | 24 | 26  |
|  Negative | 30 | 11 | 9 | 0 | 0  |

b. Matrix comparison:

Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

b. Clinical specificity:

Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable.

4. Clinical cut-off:

Not applicable.

5. Expected values/Reference range:

Not applicable.

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N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO/K163570](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIO/K163570)

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