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

K163570 · Carolina Liquid Chemistries Corporation · DIO · Aug 15, 2017 · Clinical Toxicology

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

Intended 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)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15, 2017

# CAROLINA LIQUID CHEMISTRIES CORPORATION MICA WELSH REGULATORY AFFAIRS MANAGER 575 NORTH PATTERSON AVENUE, SUITE 430 WINSTON-SALEM NC 27101

Re: K163570

Trade/Device Name: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: II Product Code: DIO Dated: July 12, 2017 Received: July 13, 2017

Dear Mica Welsh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Carolina Liquid Chemistries Cocaine Metabolite Enzyme Immunoassay (COCM)

# K163570

# 510(k) Summary

# I. Submitters Identification

| Establishment: | Carolina Liquid Chemistries, Corp. | | | | | |
|----------------------------------|-------------------------------------------|--|--|--|--|--|
| Registration Number: 3009880320 | | | | | | |
| Address: | 313 Gallimore Dairy Road | | | | | |
| | Greensboro, NC 27409 | | | | | |
| Telephone/Fax: | 877-722-8910/336-722-8915 | | | | | |
| Contact Name: | Philip G. Shugart | | | | | |
| Contact Title: | CEO/President | | | | | |
| Correspondent: | Mica A. Welsh, Regulatory Affairs Manager | | | | | |

#### II. Device Description

Common Name of Device: Cocaine and cocaine metabolite test system Trade Name of Device: Carolina Liquid Chemistries Cocaine Metabolite Test System (COCM) Classification of the Device: Class II Classification Panel: 91 Toxicology Product Code: DIO Regulation Number: 21 CFR 862.3250

# III. Identification of the Predicate Device

Common Name of Device: Cocaine and cocaine metabolite test system Trade Name of Device: Lin-Zhi International, Inc. Cocaine Metabolite Enzyme Immunoassay Classification of the Device: Class II Classification Panel: 91 Toxicology Product Code: DIO Requlation Number: 21 CFR 862.3250

# IV. Intended Use and Device Descriptions

Intended 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.

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Device Description: 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.

| | Candidate Device: Carolina Liquid<br>Chemistries Cocaine Metabolite<br>Enzyme Immunoassay (COCM) | Predicate Device: Lin-Zhi International, Inc.<br>Enzyme Immunoassay (K020763) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Carolina Liquid Chemistries Cocaine<br>and Cocaine Metabolite Test System<br>(COCM) is for the qualitative determination<br>of benzoylecgonine (cocaine metabolite) in<br>human urine at a cutoff value of 300<br>ng/mL. The assay is designed for<br>professional use with a clinical chemistry<br>analyzer. For in vitrodiagnostic use only.<br>This assay provides a rapid screening<br>procedure for determining the presence of<br>benzoylecgonine in urine. The assay<br>provides only a preliminary analytical<br>result. A more specific alternative chemical<br>method must be used in order to obtain a<br>confirmed analytical result. Gas or Liquid<br>Chromatography/Mass Spectrometry<br>(GC/MS or LC/MS) is the preferred<br>confirmatory method. Clinical<br>considerations and professional judgment<br>should be exercised with any drug of abuse<br>test result, particularly when the preliminary<br>test result is positive. | The Lin-Zhi International, Inc. Cocaine<br>Metabolite Enzyme Immunoassay is intended<br>for the qualitative and semi-quantitative<br>determination of Benzoylecgonine (Cocaine<br>Metabolite) in human urine at a cutoff value<br>of 300ng/mL. The assay is designed for<br>professional use with a number of<br>automated clinical chemistry analyzers. |
| Method | Enzyme Immunoassay | Enzyme Immunoassay |
| Reagent<br>Composition | COCM R1, Antibody/Substrate Reagent:<br>Contains mouse monoclonal<br>anti-benzoylecgonine antibody, glucose-6-<br>phosphate (G6P), and nicotinamide adenine<br>dinucleotide (NAD), stabilizers, and sodium | Antibody/Substrate Reagent (R1): Contains<br>mouse monoclonal anti-benzoylecgonine<br>antibody, glucose-6-phosphate (G6P), and<br>nicotinamide adenine dinucleotide (NAD),<br>stabilizers, and sodium azide as preservative. |
| | azide as preservative. | Enzyme-drug Conjugate Reagent (R2): |

# V. Performance Characteristics of the Device as Compared to Predicate Device

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| COCM R2, Enzyme-Drug Conjugate<br>Reagent: Contains benzoylecgonine-labeled<br>glucose-6-phosphate dehydrogenase<br>(G6PDH) in buffer with sodium azide as<br>preservative. | | | | Contains benzoylecgonine-labeled glucose-6-<br>phosphate dehydrogenase (G6PDH) in buffer<br>with sodium azide as preservative. | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------|----|
| Sample Type | Urine | | | Urine | | | |
| Expected<br>Values | The cutoff calibrator which contains 300 ng/mL benzoylecgonine is used as a<br>reference for distinguishing positive from negative samples. A sample with a change<br>in absorbance (ΔmA/min) equal to, or greater than, that obtained with the cutoff<br>calibrator is considered positive. A sample with a change in absorbance (ΔmA/min)<br>lower than that obtained with the cutoff calibrator is considered negative. | | | The cutoff calibrator which contains 300 ng/mL benzoylecgonine is used as a<br>reference for distinguishing positive from negative samples. A sample with a change in<br>absorbance (ΔmA/min) equal to, or greater than, that obtained with the cutoff calibrator<br>is considered positive. A sample with a change in absorbance (ΔmA/min) lower than<br>that obtained with the cutoff calibrator is considered negative. | | | |
| Accuracy | Candidate device compared to LCMS | | | Predicate device compared to GCMS | | | |
| | n = 100<br>Cutoff = 300ng/mL | Drug Free<br>(0.00 ng/mL) | < 50%<br>of cutoff | > 50 to<br><100%<br>of cutoff | > 100 to<br><150%<br>of cutoff | > 150% of<br>cutoff | |
| | LCMS | Positive | 0 | 0 | 0 | 24 | 26 |
| | | Negative | 30 | 11 | 9 | 0 | 0 |
| | Candidate<br>Device | Positive | 0 | 0 | 0 | 24 | 26 |
| | | Negative | 30 | 11 | 9 | 0 | 0 |
| | n = 22<br>Cutoff = 300ng/mL | | > 75 to<br><100%<br>of cutoff | | > 100 to<br><125%<br>of cutoff | | |
| | GCMS | Positive | 0 | | 9 | | |
| | | Negative | 13 | | 0 | | |
| | Predicate<br>Device | Positive | 3 | | 9 | | |
| | | Negative | 10 | | 0 | | |
| Interfering<br>Substances/<br>Cross-<br>Reactivity<br>Specificity | <b>Specific Gravity &amp; pH:</b> Study results show that<br>neither pH (range tested: 3-11), nor specific gravity<br>conditions (range tested 1.000-1.030) will interfere<br>with this assay. | | | <b>Specificity:</b> Various potentially interfering<br>substances were tested for cross-reactivity with<br>the assay. Test compounds were spiked into<br>the drug-free urine calibrator matrix to various<br>concentrations and evaluated against the<br>cutoff calibrator. The table lists the<br>concentration of each test compound that gave<br>a response approximately equivalent to that of<br>the cutoff calibrator (as positive) or the<br>maximal concentration of the compound tested<br>that gave a response below the response of the<br>cutoff calibrator (as negative). | | | |
| | | | | Structurally Related Cocaine Compounds: | | | |
| | | | | Compound | Concentration<br>(µg/mL) | Cross-<br>reactivity | |
| | | | | Benzoylecgonine | 0.3 | Positive | |
| | | | | Cocaine | 30 | Positive | |
| | | | | Norcocaine | 60 | Positive | |
| | | | | Ecgonine, Methyl<br>Ester | 350 | Positive | |

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| Compound | Concentration<br>(µg/mL) | Cross<br>reactivity |
|-----------------------|--------------------------|---------------------|
| Acetaminophen | 1500 | Negative |
| Acetylsalicyclic Acid | 1500 | Negative |
| Amobarbital | 1000 | Negative |
| Amphetamine | 1000 | Negative |
| Bupropion | 1000 | Negative |
| Caffeine | 1000 | Negative |
| Codeine | 1000 | Negative |
| Chlorpheniramine | 1000 | Negative |
| Chlorpromazine | 1000 | Negative |
| Dextromethorphan | 1000 | Negative |
| Ecgonine | 1000 | Negative |
| Lidocaine | 1000 | Negative |
| Meperidine | 1500 | Negative |
| Methadone | 1000 | Negative |
| Morphine | 2000 | Negative |
| Nicotine | 1000 | Negative |
| Oxazepam | 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 |

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| Precision | Qualitative analysis: Twenty Replicates of drug free, real human urine were spiked with benzoylecgonine to nine concentrations and tested in a single run using the COCM EIA on a Biolis 24i. Results are as follows: | | | | Qualitative analysis: The three calibrators and two levels of controls were evaluated. Typical results (ΔmA/min) are as follows: | | | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------|------|------|
| | Within Run | | | | | | | |
| | | | | | Within Run | | | |
| | | | | | (mA/min) | Mean | SD | %CV |
| DRI Multi-Drug<br>Calibrators<br>K#983159 | Concentration<br>(ng/mL) | % cutoff<br>(300ng/mL) | # of<br>Samples | Results | Negative | 219.8 | 1.25 | 0.6 |
| | 0 | 0% | 20 | 20 Negative | 225 ng/mL | 289.4 | 1.92 | 0.7 |
| | 75 | -75% | 20 | 20 Negative | 300 ng/mL | 310.1 | 1.15 | 0.4 |
| | 150 | -50% | 20 | 20 Negative | 375 ng/mL | 327.3 | 1.05 | 0.3 |
| | 225 | -25% | 20 | 20 Negative | 1000 ng/mL | 497.8 | 3.47 | 0.7 |
| MGC Primary<br>DAU Controls<br>K#040758 | 300 | Cutoff<br>(100%) | 20 | 15 Negative /<br>5 Positive | | | | |
| | 375 | +25% | 20 | 20 Positive | | | | |
| | 450 | +50% | 20 | 20 Positive | Run-to-Run | | | |
| | 525 | +75% | 20 | 20 Positive | (taken in 3 weeks) | | | |
| | 600 | +100% | 20 | 20 Positive | (mA/min) | Mean | SD | %CV |
| | Run-to-Run | | | | Negative | 247.6 | 3.2 | 1.25 |
| | Concentration<br>(ng/mL) | % of<br>cutoff | # of<br>samples | Results | 225 ng/mL | 340.8 | 4.8 | 1.38 |
| | Negative: 0<br>ng/mL | 0% | 90 | 90 Negative | 300 ng/mL | 360.2 | 4.5 | 1.22 |
| | 75 ng/mL | -25% | 90 | 90 Negative | 375 ng/mL | 370.2 | 4.2 | 1.09 |
| | 150 ng/mL | -50% | 90 | 90 Negative | 1000 ng/mL | 524.4 | 5.6 | 1.07 |
| | 225 ng/mL | -75% | 90 | 90 Negative | | | | |
| | 300 ng/mL | 100% | 90 | 84 Positive/<br>6 Negative | | | | |
| | 375 ng/mL | 125% | 90 | 90 Positive | | | | |
| | 450 ng/mL | 150% | 90 | 90 Positive | | | | |
| | 525 ng/mL | 175% | 90 | 90 Positive | | | | |
| | 600 ng/mL | 200% | 90 | 90 Positive | | | | |
| Carryover | 0.00 ng/mL | | | | Test was not performed on the predicate device | | | |

1.Similarities:

- > Test methodology is identical
- √ Reagent composition is identical
- √ Sample type (urine) is the same
- V Expected values for the qualitative assay are identical

2.Differences:

- > The intended use for the predicate device is qualitative and semi-quantitative, whereas, the intended use of the CLC Cocaine Metabolite Enzyme Immunoassay (COCM) is qualitative only.
- 3.Summary for Performance Testing

The CLC Cocaine Metabolite Enzyme Immunoassay demonstrated similar performance characteristics as compared to the predicate device when tested using the approved guidelines provided in the CLSI Standards listed below. The candidate device utilizes a chemical make-up for both Reagent 1 and Reagent 2 that is identical to what is in use with the predicate device. No new

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issues of safety or effectiveness are introduced by using this CLC Cocaine Metabolite Enzyme lmmunoassay (COCM).

# 4.Performance Standards Used

- 1) CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Procedures; Approved Guideline-Third Edition
- 2) CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition
- 3) CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition
- 4) CLSI EP10-A3: Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline-Third Edition

# 5.Conclusion

The Carolina Liquid Chemistries Cocaine Metabolite Enzyme Immunoassay (COCM) is substantially equivalent to the Lin-Zhi International Cocaine Metabolites Enzyme Immunoassay (the predicate device), for purposes of Section 510(k) of the federal Food, Drug and Cosmetic Act. The predicate device is currently available for commercial distribution in interstate commerce.