(239 days)
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.
| Performance Characteristic | Acceptance Criteria (Implicit, based on Predicate/Reference Method) | Reported Device Performance (Carolina Liquid Chemistries COCM) |
|---|---|---|
| Accuracy | High concordance with LCMS for positive and negative samples at various concentrations relative to the 300 ng/mL cutoff, similar to predicate device's performance against GCMS. | Candidate device compared to LCMS (n=100 specimens) - Drug Free (0.00 ng/mL): 30 Negative (100% negative) - < 50% of cutoff (75-149 ng/mL): 11 Negative (100% negative) - > 50 to < 100% of cutoff (150-299 ng/mL): 9 Negative (100% negative) - > 100 to < 150% of cutoff (301-449 ng/mL): 24 Positive (100% positive) - > 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 < 2% for all reported concentrations). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Accuracy Test Set: n = 100 samples. The origin of the data (country, retrospective/prospective) is not specified in the provided text. It indicates "real human urine" was used for the precision study, which might apply to accuracy as well.
- Precision Test Set:
- Within Run: 20 replicates for each of the 9 spiked concentrations.
- Run-to-Run: 90 replicates for each of the 9 spiked concentrations.
- The samples were "real human urine" spiked with benzoylecgonine. The provenance (country, retrospective/prospective) is not specified.
- Interfering Substances/Cross-Reactivity: Not a "test set" of patient samples, but rather analytical samples spiked with various substances into a "drug-free urine calibrator matrix." The number of samples for each substance is not specified, but multiple concentrations were tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This study does not involve human experts interpreting results. The ground truth for the test set is established using analytical reference methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the ground truth is established by objective analytical methods (LCMS/GCMS). There is no "adjudication" of human interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a study validating an in vitro diagnostic (IVD) device for drug detection, not an AI-assisted diagnostic imaging study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this study is inherently a standalone performance evaluation of the device. The "algorithm" here is the enzyme immunoassay itself, which provides a quantitative or qualitative result without human-in-the-loop interpretation beyond reading the instrument output. The comparison is made directly against a confirmatory analytical method (LCMS).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the accuracy study is:
- Highly sensitive and specific analytical methods: Liquid Chromatography/Mass Spectrometry (LCMS) for the candidate device, and Gas Chromatography/Mass Spectrometry (GCMS) for the predicate device. These are considered gold standards for confirming the presence and concentration of drugs/metabolites in biological samples.
8. The sample size for the training set
This document describes a validation study for a fully developed IVD device, not an AI model that requires a "training set." The device is a "ready-to-use, liquid reagent, homogenous enzyme immunoassay" and its "chemical make-up for both Reagent 1 and Reagent 2...is identical to what is in use with the predicate device." Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI model. The chemical composition and reaction principles of the immunoassay are based on established scientific methods and the predicate device.
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 LiquidChemistries Cocaine MetaboliteEnzyme Immunoassay (COCM) | Predicate Device: Lin-Zhi International, Inc.Enzyme Immunoassay (K020763) | |
|---|---|---|
| Intended Use | The Carolina Liquid Chemistries Cocaineand Cocaine Metabolite Test System(COCM) is for the qualitative determinationof benzoylecgonine (cocaine metabolite) inhuman urine at a cutoff value of 300ng/mL. The assay is designed forprofessional use with a clinical chemistryanalyzer. For in vitrodiagnostic use only.This assay provides a rapid screeningprocedure for determining the presence ofbenzoylecgonine in urine. The assayprovides only a preliminary analyticalresult. A more specific alternative chemicalmethod must be used in order to obtain aconfirmed analytical result. Gas or LiquidChromatography/Mass Spectrometry(GC/MS or LC/MS) is the preferredconfirmatory method. Clinicalconsiderations and professional judgmentshould be exercised with any drug of abusetest result, particularly when the preliminarytest result is positive. | The Lin-Zhi International, Inc. CocaineMetabolite Enzyme Immunoassay is intendedfor the qualitative and semi-quantitativedetermination of Benzoylecgonine (CocaineMetabolite) in human urine at a cutoff valueof 300ng/mL. The assay is designed forprofessional use with a number ofautomated clinical chemistry analyzers. |
| Method | Enzyme Immunoassay | Enzyme Immunoassay |
| ReagentComposition | COCM R1, Antibody/Substrate Reagent:Contains mouse monoclonalanti-benzoylecgonine antibody, glucose-6-phosphate (G6P), and nicotinamide adeninedinucleotide (NAD), stabilizers, and sodium | Antibody/Substrate Reagent (R1): Containsmouse monoclonal anti-benzoylecgonineantibody, glucose-6-phosphate (G6P), andnicotinamide adenine dinucleotide (NAD),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 ConjugateReagent: Contains benzoylecgonine-labeledglucose-6-phosphate dehydrogenase(G6PDH) in buffer with sodium azide aspreservative. | Contains benzoylecgonine-labeled glucose-6-phosphate dehydrogenase (G6PDH) in bufferwith sodium azide as preservative. | ||||||
|---|---|---|---|---|---|---|---|
| Sample Type | Urine | Urine | |||||
| ExpectedValues | The cutoff calibrator which contains 300 ng/mL benzoylecgonine is used as areference for distinguishing positive from negative samples. A sample with a changein absorbance (ΔmA/min) equal to, or greater than, that obtained with the cutoffcalibrator is considered positive. A sample with a change in absorbance (ΔmA/min)lower than that obtained with the cutoff calibrator is considered negative. | The cutoff calibrator which contains 300 ng/mL benzoylecgonine is used as areference for distinguishing positive from negative samples. A sample with a change inabsorbance (ΔmA/min) equal to, or greater than, that obtained with the cutoff calibratoris considered positive. A sample with a change in absorbance (ΔmA/min) lower thanthat obtained with the cutoff calibrator is considered negative. | |||||
| Accuracy | Candidate device compared to LCMS | Predicate device compared to GCMS | |||||
| n = 100Cutoff = 300ng/mL | Drug Free(0.00 ng/mL) | < 50%of cutoff | > 50 to<100%of cutoff | > 100 to<150%of cutoff | > 150% ofcutoff | ||
| LCMS | Positive | 0 | 0 | 0 | 24 | 26 | |
| Negative | 30 | 11 | 9 | 0 | 0 | ||
| CandidateDevice | Positive | 0 | 0 | 0 | 24 | 26 | |
| Negative | 30 | 11 | 9 | 0 | 0 | ||
| n = 22Cutoff = 300ng/mL | > 75 to<100%of cutoff | > 100 to<125%of cutoff | |||||
| GCMS | Positive | 0 | 9 | ||||
| Negative | 13 | 0 | |||||
| PredicateDevice | Positive | 3 | 9 | ||||
| Negative | 10 | 0 | |||||
| InterferingSubstances/Cross-ReactivitySpecificity | Specific Gravity & pH: Study results show thatneither pH (range tested: 3-11), nor specific gravityconditions (range tested 1.000-1.030) will interferewith this assay. | Specificity: Various potentially interferingsubstances were tested for cross-reactivity withthe assay. Test compounds were spiked intothe drug-free urine calibrator matrix to variousconcentrations and evaluated against thecutoff calibrator. The table lists theconcentration of each test compound that gavea response approximately equivalent to that ofthe cutoff calibrator (as positive) or themaximal concentration of the compound testedthat gave a response below the response of thecutoff calibrator (as negative). | |||||
| Structurally Related Cocaine Compounds: | |||||||
| Compound | Concentration(µg/mL) | Cross-reactivity | |||||
| Benzoylecgonine | 0.3 | Positive | |||||
| Cocaine | 30 | Positive | |||||
| Norcocaine | 60 | Positive | |||||
| Ecgonine, MethylEster | 350 | Positive |
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| Compound | Concentration(µg/mL) | Crossreactivity |
|---|---|---|
| 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-DrugCalibratorsK#983159 | Concentration(ng/mL) | % cutoff(300ng/mL) | # ofSamples | 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 PrimaryDAU ControlsK#040758 | 300 | Cutoff(100%) | 20 | 15 Negative /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(ng/mL) | % ofcutoff | # ofsamples | Results | 225 ng/mL | 340.8 | 4.8 | 1.38 | |
| Negative: 0ng/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/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
-
- 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 EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition
-
- 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.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
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.(b)
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).