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

Intended 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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January 27, 2022

Carolina Liquid Chemistries, Corp. Philip Shugart Chief Executive Officer 313 Gallimore Dairy Road Greensboro, North Carolina 27409

Re: K213211

Trade/Device Name: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: September 27, 2021 Received: September 29, 2021

Dear Philip Shugart:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) k213211

#### Device Name

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

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

# 510(k)#: K213211

# A) Device Information:

| Sponsor/Company Name: | Carolina Liquid Chemistries, Corp.<br>313 Gallimore Dairy RD.<br>Greensboro, NC 27409<br>Phone: [phone]<br>Fax: [phone] |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent Contact Information: | Philip G Shugart<br>CEO<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Common Name of Device: | Enzyme Immunoassay Cocaine and Cocaine<br>Metabolites |
| Trade Name of Device: | Carolina Liquid Chemistries Cocaine and<br>Cocaine Metabolite Enzyme Immunoassay<br>(COCM) Test System. |
| Device Product Code, Classification,<br>Classification Name & Panel | DIO, Class II, 21 CFR 862.3250 Opiate Test<br>System 91-Toxicology |

## Predicate Device Information

| Predicate Device: | Cocaine Metabolite Enzyme Immunoassay |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Predicate Device Manufacturer: | Lin-Zhi International |
| Predicate Device Common | Cocaine Metabolite Enzyme Immunoassay |
| Predicate Device Premarket Notification # | K020763 |
| Predicate Device Product Code,<br>Classification, Classification Name &<br>Panel | DIO, Class II, 21 CFR 862.3250 Opiate Test<br>System 91-Toxicology |

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#### B) Device Description:

The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is a ready-to-use, liquid reagent homogeneous enzyme immunoassay for qualitatively determining the presence of cocaine metabolite (benzoylecgonine) in human urine. The assay uses specific antibody that can detect benzoylecgonine in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine labeled with the enzyme glucose-6phosphate 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.

## C) Indications for Use:

The Carolina Liquid Chemistries Cocaine and 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.

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## D) Predicate Product Comparison Chart:

| Characteristic: | Candidate Device: | Predicate Device: |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Identifier and Submitter | Carolina Liquid Chemistries Corporation Cocaine<br>Metabolite Enzyme Immunoassay (COCM) Test System | Cocaine Metabolite Enzyme Immunoassay Lin-Zhi<br>International, Inc (K020763) |
| Indication for Use | The Carolina Liquid Chemistries Cocaine and Cocaine<br>Metabolite Enzyme Immunoassay (COCM) Test System is<br>intended for the qualitative determination of<br>benzoylecgonine (cocaine metabolite) in human urine at a<br>cut off value of 300 ng/mL. The assay is designed for<br>professional use on the CLC6410 automated clinical<br>chemistry analyzer. For in vitro diagnostic use only. | The Lin-Zhi Cocaine Metabolite Enzyme Immunoassay is<br>intended for the qualitative and semi-quantitative<br>determination of benzoylecgonine (cocaine metabolite) in<br>human urine at a cut off value of 300 ng/mL. The assay is<br>designed for professional use on a number of automated<br>clinical chemistry analyzer. For in vitro diagnostic use only. |
| Operating Principle Technology | The assay is based on competition<br>between drug in the sample and drug labeled with the<br>enzyme glucose-6- phosphate<br>dehydrogenase (G6PDH) for a fixed amount of antibody in<br>the reagent Enzyme Immunoassay | Same |
| Measurand Analyte | Cocaine Metabolite (benzoylecgonine) | Same |
| Test Matrix | Urine | Same |
| Methodology | Homogeneous Enzyme Immunoassay | Same |
| Reagent Form | Liquid Ready to Use | Same |
| Antibody | mouse monoclonal<br>anti-benzoylecgonine antibody | Same |
| Storage Temp | 2-8-C | Same |
| Principal Operator | Trained Professionals | Same |
| Calibrator Levels | 2 | Same |
| Reference Instrument | CLC6410 | Syncron CX4CE |

## E) Test Principle:

The Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme immunoassay readyto-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6- phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, benzoylecgonine-labeled G6PDH conjugate is bound to the antibody, and

the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody binds the free drug; the unbound benzoylecgonine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

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# F) Summary of Supporting Data: Analytical Performance

- Precision- Precision was determined by spiking benzoylecgonine into drug free urine a. at the following concentrations (0, -75%, -50%, -25%, cutoff (300 ng/mL), +125%, +150%, +175% and 200%). Testing for within run was performed by running two replicates of each sample twice in one day. The between run was performed by running two replicates of each sample twice a day for 22 non-consecutive days. All sample concentrations were verified by a confirmatory method (LCMS). The results for the 300 ng/mL cutoff are summarized in the table below:

| Within Run | | | |
|------------|---------------|----|---------|
| % Cutoff | Concentration | N | Neg/Pos |
| 0% | 0 | 4 | 4/0 |
| -75% | 75 | 4 | 4/0 |
| -50% | 150 | 4 | 4/0 |
| -25% | 225 | 4 | 4/0 |
| Cutoff | 300 | 4 | 3/1 |
| 125% | 375 | 4 | 0/4 |
| 150% | 450 | 4 | 0/4 |
| 175% | 525 | 4 | 0/4 |
| 200% | 600 | 4 | 0/4 |
| Run-to-Run | | | |
| % Cutoff | Concentration | N | Neg/Pos |
| 0% | 0 | 88 | 88/0 |
| -75% | 75 | 88 | 88/0 |
| -50% | 150 | 88 | 88/0 |
| -25% | 225 | 88 | 88/0 |
| Cutoff | 300 | 88 | 53/35 |
| 125% | 375 | 88 | 0/88 |
| 150% | 450 | 88 | 0/88 |
| 175% | 525 | 88 | 0/88 |

- Specificity- Specificity of the assay is supported by cross reactivity studies that b. supported the predicate device, k020763
#### Interference Testing-C.

1) The Effect of pH: To investigate the effect of urine pH, negative human urine samples was divided into nine pools. Those pools were adjusted using sodium hydroxide (NaOH) and/or hydrochloric acid (HCL) to various pH conditions. After the pools were adjusted for pH, they were measured and the actual pH of each recorded. They were then divided in half so that there were two at each pH

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level. Each half was then spiked with benzoylecgonine: one to 225 ng/mL and the other to 375 ng/mL (±25% of the 300 ng/mL cutoff). These 18-real human urine samples were then tested using the COCM Reagent Kit and results recorded in a table formatted similarly below.

| Interfering<br>Substances- | Actual pH | | Test Result- | Actual pH | | Test Result- |
|----------------------------|-----------|------|--------------------|-----------|------|--------------------|
| pH | pH Target | | 225ng/mL<br>Target | pH Target | | 375ng/mL<br>Target |
| | 3 | 3.1 | Neg | 3 | 3.1 | Pos |
| | 4 | 4 | Neg | 4 | 3.9 | Pos |
| | 5 | 4.9 | Neg | 5 | 5.1 | Pos |
| | 6 | 6.1 | Neg | 6 | 6 | Pos |
| | 7 | 6.9 | Neg | 7 | 6.8 | Pos |
| | 8 | 8 | Neg | 8 | 8 | Pos |
| | 9 | 8.8 | Neg | 9 | 9.1 | Pos |
| | 10 | 10.1 | Neg | 10 | 10 | Pos |
| | 11 | 11 | Neg | 11 | 11.1 | Pos |

2) The Effect of Specific Gravity: To investigate the effect of urine specific gravity, negative human urine samples were divided into ten pools. These pools were adjusted using DI water and sodium chloride to the following target specific gravity conditions. After the pools were adjusted for specific gravity, they were measured, and the actual specific gravity was recorded. Each pool was then divided in half so there were two at each level of specific gravity. Each half was then spiked with benzoylecgonine: one to 225 ng/mL and the other to 375 ng/mL ±25% of the 300 ng/mL cutoff). Those 20-real human urine samples were then tested using the COCM Reagent Kit. The results were recorded in the table below.

| Interfering<br>Substances | | | Test Result | | | Test Result |
|---------------------------|-----------|-----------|--------------------|-----------|-----------|--------------------|
| SG | SG Target | Actual SG | 225ng/mL<br>Target | SG Target | Actual SG | 375ng/mL<br>Target |
| | 1.000 | 1.000 | Neg | 1.000 | 1.001 | Pos |
| | 1.003 | 1.002 | Neg | 1.003 | 1.004 | Pos |
| | 1.007 | 1.007 | Neg | 1.007 | 1.008 | Pos |
| | 1.011 | 1.010 | Neg | 1.011 | 1.010 | Pos |
| | 1.012 | 1.013 | Neg | 1.012 | 1.013 | Pos |
| | 1.017 | 1.017 | Neg | 1.017 | 1.017 | Pos |
| | 1.018 | 1.019 | Neg | 1.018 | 1.019 | Pos |
| | 1.021 | 1.021 | Neg | 1.021 | 1.021 | Pos |
| | 1.024 | 1.025 | Neg | 1.024 | 1.025 | Pos |
| | 1.028 | 1.029 | Neg | 1.028 | 1.028 | Pos |

No Substantial Interference was noted.

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d. Carryover Testing- To determine carryover 21 samples, 10 "High" samples were spiked with benzoylecgonine at (1000 ng/mL) and 11 "Low" (0 ng/mL). They were assayed in the following order:

| Carryover | Sample 1 (0) | Neg | Sample 8<br>(1000) | Pos | Sample 15<br>(0) | Neg |
|-----------|--------------------|-----|---------------------|-----|---------------------|-----|
| | Sample 2 (0) | Neg | Sample 9 (0) | Neg | Sample 16<br>(1000) | Pos |
| | Sample 3 (0) | Neg | Sample 10<br>(0) | Neg | Sample 17<br>(1000) | Pos |
| | Sample 4<br>(1000) | Pos | Sample 11<br>(0) | Neg | Sample 18<br>(0) | Neg |
| | Sample 5<br>(1000) | Pos | Sample 12<br>(0) | Neg | Sample 19<br>(1000) | Pos |
| | Sample 6 (0) | Neg | Sample 13<br>(1000) | Pos | Sample 20<br>(1000) | Pos |
| | Sample 7<br>(1000) | Pos | Sample 14<br>(1000) | Pos | Sample 21<br>(0) | Neg |

No Carryover was noted during testing.

e. Method Comparison and Accuracy- Using 81 samples across the range of the assay should be tested according to the following distribution:

- · 41 LC/MS Confirmed Negative Samples
- 20 drug-free samples.
- Remaining 21 samples between 0 ng/mL to 300 ng/mL.
- 8 of the above 21 negative samples were within -50% of cutoff (150 ng/mL to 300 ng/mL)
- · 40 LC/MS Confirmed Positives Samples
- At least 8 samples within +50% of cutoff (300 ng/mL to 450 ng/mL)

All remaining samples greater than 300 ng/mL

Qualitative Mode Accuracy study with LC-MS/MS as reference method for 300 ng/mL cutoff shown below:

| Results<br>N=81<br>Cutoff=300ng/mL | Drug Free<br>0 ng/mL | Low Negative<br><50% off Cutoff<br>(150ng/mL) | Near Cutoff<br>Negative<br>Between 50%<br>and 99% of<br>Cutoff<br>(150-299 ng/mL) | Near Cutoff<br>Positive<br>Between 100%<br>and 150% of<br>Cutoff<br>(300-450 ng/mL) | High Positive<br>>150% of Cutoff<br>(>450 ng/mL) | % Agreement |
|------------------------------------|----------------------|-----------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------|-------------|
| Positive | | | | 8 | 32 | 100% |
| Negative | 20 | 11 | 10 | | | 100% |

Agreement among positives: 100% /Agreement among negatives: 100%

No discordant samples were identified

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#### Conclusion:

The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) was evaluated for several performance characteristics, including precision, sensitivity, accuracy, analytical recovery, specificity, carryover, and interference. All studies show acceptable results when compared to the predicate device.

In conclusion, the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) is substantially equivalent to the predicate.