The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoids in human head and body hair samples using a 11-nor-9-Carboxy- Δ'-THC calibrator at 10 pg/10 mg hair cutoff for the purpose of identifying marijuana use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.

The Psychemedics Chemiluminscent Microplate EIA for Cannabinoids assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Description

The EIA screening test consists of two parts; a pre-analytical hair treatment procedure to recover the cannabinoids from the hair and the screening assay, the Psychemedics Chemiluminescent EIA for Cannabinoids in Hair. The device comprises a white microplate coated with the antigen (11-nor-9-carboxy-delta-8-tetrahydrocannabinol) conjugated to BSA, polyclonal rabbit anticannabinoid antibody, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), a chemiluminescent substrate, and platewashing buffer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device and showing agreement with the confirmatory method (GC/MS/MS). While explicit percentage targets for sensitivity and specificity are not directly stated as "acceptance criteria," the performance in the agreement testing (both with the predicate and GC/MS/MS) is presented to show the device meets the regulatory requirements for substantial equivalence.

Acceptance Criteria Category	Description	Reported Device Performance
Agreement with Predicate Device (EIA vs RIA)	Low discordance with the predicate device (Psychemedics Marijuana Screening and Confirmatory Test System, K011426) for preliminary qualitative detection of cannabinoids in hair.	Out of 610 hair samples: - EIA Positive, Predicate Negative: 4 - EIA Negative, Predicate Positive: 2 - EIA Positive, Predicate Positive: 189 - EIA Negative, Predicate Negative: 415 Discordance < 1%
Agreement with Confirmatory Method (EIA vs GC/MS/MS)	High agreement with Gas Chromatography/Mass Spectrometry/Mass Spectrometry (GC/MS/MS) for samples around and above the cutoff. The EIA should accurately identify negative and positive samples, especially those confirmed as positive by GC/MS/MS. A small number of false positives or false negatives by EIA near the cutoff is expected to be further addressed by confirmation.	Out of 318 samples confirmed by LC/MS/MS: - EIA Positive, GC/MS/MS Negative: 0 - EIA Positive, GC/MS/MS ≥ -50% Cutoff and < Cutoff: 5 - EIA Positive, GC/MS/MS ≥ Cutoff and < +50% Cutoff: 1 - EIA Positive, GC/MS/MS ≥ +50% Cutoff and < 100% Cutoff: 7 - EIA Positive, GC/MS/MS ≥ +100% Cutoff: 176 - EIA Negative, GC/MS/MS Negative: 127 - EIA Negative, GC/MS/MS ≥ -50% Cutoff and < Cutoff: 0 - EIA Negative, GC/MS/MS ≥ Cutoff and < +50% Cutoff: 1 - EIA Negative, GC/MS/MS ≥ +50% Cutoff and < 100% Cutoff: 0 - EIA Negative, GC/MS/MS ≥ +100% Cutoff: 1
Precision (Intra-Assay & Inter-Assay)	Consistent and reproducible results across different levels (negative, positive, and various percentages around the cutoff) within a single assay run (intra-assay) and between different assay runs (inter-assay).	Intra-Assay (15 replicates per level): - Negative levels (-100% to -25%) all showed 15 negative results, 0 positive results. - Positive levels (+25% to +100%) all showed 0 negative results, 15 positive results. Inter-Assay (75 replicates per level): - Negative levels (-100% to -25%) all showed 75 negative results, 0 positive results. - Positive levels (+25% to +100%) all showed 0 negative results, 75 positive results.
Impact of Cosmetic Treatments	Cosmetic treatments (bleach, permanent wave, dye, relaxer, shampoo) should not cause false negative results in cannabinoid-positive hair samples and should not cause false positive results in cannabinoid-negative hair samples.	- Negative Samples (20 per treatment type): All remained negative after treatment. - Positive Samples (12 per treatment type): No positive samples became negative in the EIA after cosmetic treatments. Mean (Range) B/B0 x 100 values before and after treatment showed no significant trend towards false negatives.
Environmental Contamination	The device and subsequent confirmation method should be able to differentiate between environmental contamination (e.g., marijuana smoke) and actual drug use (presence of Carboxy-THC metabolite). Environmental contamination should not lead to false positives for Carboxy-THC after the wash procedure and GC/MS/MS confirmation.	- Smoke-contaminated samples (12): All were positive by EIA. GC/MS/MS showed no Carboxy-THC, but high THC (189-788 ng/10 mg hair). This demonstrates the EIA's sensitivity to environmental THC, but the crucial point is the absence of Carboxy-THC after the wash and GC/MS/MS. - Washed smoke-contaminated samples: No Carboxy-THC detected after standard wash procedure. - Water/saline soaked smoke-contaminated samples: Positive in EIA, but no Carboxy-THC detected by GC/MS/MS.
Cross-reactivity and Interference	The device should not cross-react with common interfering substances or show interference from other compounds that could lead to false positives or negatives.	- Cross-reactivity: Investigated for sixty-seven compounds. (Specific results not detailed, but the conclusion states "demonstrated the Cannabinoid EIA to be substantially equivalent with the predicate.") - Interference: Seventy-five compounds tested at +/- 50% of the cutoff showed no interference.
Stability of Calibrator and Control Solutions	Calibrator and control solutions should maintain stability for a specified period.	Stability in methanol was shown for 1 year for the carboxy-THC calibrator and control solutions.
Recovery Study	The recovery of cannabinoids from hair samples of marijuana users should be comparable to that of the predicate device.	Recovery of cannabinoids from hair of marijuana users was shown to be substantially equivalent to that of the predicate device.

Study Details

2. Sample Size Used for the Test Set and Data Provenance

Agreement Testing with Predicate Device:
- Sample Size: 610 hair samples (18.9% body hair, remainder head hair).
- Data Provenance: Not explicitly stated, but given it's Psychemedics' own product and existing predicate, it's likely internal laboratory data, possibly collected retrospectively from their testing services. No country of origin is specified.
Agreement Testing with GC/MS/MS:
- Sample Size: 318 of the 610 samples after preliminary testing were further confirmed by LC/MS/MS.
- Data Provenance: Not explicitly stated.
Cosmetic Treatment Studies:
- Negative Samples: 20 cannabinoid-negative hair samples (10 per brand for each cosmetic type).
- Positive Samples: 12 cannabinoid-positive hair samples (6 per brand for each cosmetic type).
- Data Provenance: Not explicitly stated.
Contamination Study:
- Sample Size: 12 hair samples (various colors, including red).
- Data Provenance: Lab-generated (experimentally contaminated with marijuana smoke).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Agreement with Predicate Device: The "ground truth" for this comparison was the result from the predicate device (Psychemedics Marijuana Screening and Confirmatory Test System, using RIA and GC/MS/MS). This implies the ground truth was established by the predicate device's methodology, which includes laboratory analysis. No individual human experts are described as establishing this particular ground truth, but rather the established method.
Agreement with Confirmatory Method (GC/MS/MS): The ground truth for this segment of the study was established by LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) which is stated elsewhere to be GC/MS/MS (Gas Chromatography/Mass Spectrometry/Mass Spectrometry), the "preferred confirmatory method" for drugs of abuse testing. This is a highly accurate analytical chemical method. No human experts are described as manually interpreting or establishing this ground truth, as it's an objective chemical measurement.
Cosmetic Treatment and Contamination Studies: The ground truth for these was either inferred from known negative/positive status of samples (for cosmetic treatments) or the known contamination event and the subsequent GC/MS/MS analysis (for the contamination study). Again, no specific human experts are detailed for establishing this ground truth, it's based on analytical results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving human experts for resolving disagreements. The comparisons rely on:

Direct comparison of the investigational device's EIA results against the predicate device's RIA results for agreement.
Direct comparison of the investigational device's EIA results against the objective chemical analysis results from LC/MS/MS (or GC/MS/MS) as the definitive ground truth for drug presence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is an in vitro diagnostic device (EIA assay) for preliminary qualitative detection, not an imaging device or one that relies on human interpretation for its primary output. Therefore, an MRMC study is not applicable or described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (precision, agreement with predicate, agreement with GC/MS/MS, cosmetic treatment, contamination, cross-reactivity, interference, stability, recovery) are all reflective of the standalone performance of the Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair. The device itself performs the assay, and the results are read by a microplate reader. While a human initiates the test and interprets the final result in the context of a cutoff, the performance metrics reported are for the assay system's analytical capabilities without human interpretative intervention in the measurement itself. The device provides "only a preliminary analytical test result," emphasizing its standalone nature as a screening tool.

7. The Type of Ground Truth Used

The primary ground truth used is objective chemical analysis:

For agreement studies, GC/MS/MS (Gas Chromatography/Mass Spectrometry/Mass Spectrometry) or LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) is explicitly stated as the preferred confirmatory method and was used to confirm 318 samples.
The predicate device itself also uses mass spectrometry for confirmation as part of its "bipartite device." This implies an analytical, rather than expert consensus or pathology-based, ground truth.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the device. As an immunoassay (EIA), this device likely uses a predetermined set of reagents and a fixed protocol, rather than a machine learning algorithm that requires a traditional training set. The development of the assay itself would have involved extensive R&D, but the data presented here are for validation and performance testing of the finalized assay.

9. How the Ground Truth for the Training Set Was Established

Since no explicit training set for an algorithm is mentioned, this question is not directly applicable. The assay's development and optimization would have relied on known positive and negative samples, with their true status confirmed by robust analytical methods like GC/MS/MS.

Summary

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イ

510K SUMMARY

510K Number: Submitted By:

K111929 Psychemedics Corporation 5832 Uplander Way Culver City, CA 90230 TEL: 310 216 7776 FAX: 310 216 6662

Submission Contact:

Virginia Hill

Date Prepared:

April 25, 2012

LDJ

Device Trade Name:

Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair

Psychemedics Marijuana Screening and Confirmatory Test System

21 CFR 862.3870, Enzyme Immunoassay, Cannabinoids;

Predicate Device:

Product Code:

Device Classification/Name:

Intended Use:

Assay Description:

Classification II; The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoids in human head and body hair samples using a 11nor-9-Carboxy- Δ -THC calibrator at 10 pg/10 mg hair cutoff for the purpose of identifying marijuana use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.

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Sample Collection:

A sample of hair should be cut as close as possible to the skin. The hair is placed in a V-shaped aluminum foil sample holder with the root end of the hair protruding beyond the slanted edge of the foil. The aluminum foil is crimped around the sample, securing the hair specimen firmly into place within the foil. The hair sample crimped within the foil is placed in a sample acquisition card envelope and the envelope is sealed with a tamper-evident seal. Hair specimens are kept at ambient temperature in a secure location until they are shipped without refrigeration to the laboratory.

Materials required:

Hair sample collection kit, Chemiluminescent Microplate EIA for Cannabinoids, Microplate washer and reader, GC/MS/MS for confirmation.

Item	Device	Predicate
Indications for Use	The Psychemedics Microplate EIA forCannabinoids in Hair is an enzymeimmunoassay (EIA) for thepreliminary qualitative detection ofcannabinoids in human head andbody hair samples using a 11-nor-9-Carboxy- Δ9-THC calibrator at 10pg/10 mg hair cutoff for the purposeof identifying marijuana use. This isan in vitro diagnostic device intendedexclusively for Psychemedics use onlyand is not intended for sale to anyone.The test is not intended for over thecounter sale to non-professionals.The Psychemedics ChemiluminscentMicroplate EIA for Cannabinoids assayprovides only a preliminary analyticaltest result. A more specific alternativechemical method must be used in orderto obtain a confirmed analytical result.Gas Chromatography/MassSpectrometry/Mass Spectrometry(GC/MS/MS) is the preferredconfirmatory method. Clinicalconsideration and professionaljudgment should be exercised with anydrug of abuse test result, particularlywhen the preliminary result is positive.	The Psychemedics MarijuanaScreening and Confirmatory TestSystem is a bipartite deviceemploying radioimmunoassay (RIA)for qualitative screening and massspectrometry for confirmation and thefinal quantitative reporting ofcarboxy-THC in human hair samplesat concentrations at or above 1 pgcarboxy-THC/10 mg hair for thepurpose of determining marijuana use.This product is intended exclusivelyfor in-house professional use only.The test is not intended for over thecounter sale to nonprofessionals.Clinical consideration andprofessional judgment should beapplied to any drug of abuse testresult.
510k	K111929	K011426
Measurand	Carboxy-THC /Cannabinoids	Carboxy-THC /Cannabinoids
Matrix	Human head or body hair	Human head or body hair
Cutoff	10 pg carboxy-THC/10 mg hair	1 pg carboxy-THC/10 mg hair

Comparison of Psychemedics Chemiluminescent Microplate EIA for Cannabinoids with Psychemedics Marijuana Screening and Confirmatory Test System

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Type of Test	Enzyme Immunoassay	Radioimmunoassay
Method ofMeasurement	Microplate reader	Gamma Counter
Extraction Method	Acidic Extraction	Proteolytic Digestion
Confirmation	GC/MS/MS	GC/MS/MS

Summary of Performance Testing

Summary of Precision Studies

Summary -Intra-Assay			Summary-Inter-Assay
LEVEL	NEG	POS	LEVEL	NEG	POS
B₀ (-100%)	15	0	B₀ (-100%)	75	0
-75%	15	0	-75%	75	0
-50%	15	0	-50%	75	0
-25%	15	0	-25%	75	0
plus 25%	0	15	plus 25%	0	75
plus 50%	0	15	plus 50%	0	75
plus 75%	0	15	plus 75%	0	75
plus 100%	0	15	plus 100%	0	75

Agreement Testing

Six-hundred-ten hair samples were assayed by the predicate device and by the Psychemedics Methamphetamine EIA. The number of body hair samples in the study was 18.9% of the total hair samples. The discordance between EIA and RIA was < 1%.

	Negative by Predicate	Positive by Predicate
EIA Positive	4	189
EIA Negative	415	2

Three-hundred-eighteen of the samples were confirmed by LC/MS/MS, with the results shown in the following table.

GC/MS/MS:	Negative	≥ -50% ofCutoff and <Cutoff	≥ Cutoff and <+50% ofCutoff	≥ +50%Cutoff and <100% ofCutoff	≥ +100% ofcutoff
EIA Positive	0	5	1	7	176
EIA Negative	127	0	1	0	1

Cosmetic Treatment

Twenty cannabinoid-negative hair samples were treated with bleach, 20 with permanent wave, 20 with dye, 20 with relaxer, and 20 with shampoo, and the results compared to the same samples without the

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treatments. In each case of the 20 samples treated with a type of cosmetic treatment, 10 samples were treated with one brand of a particular product and 10 other samples with a second brand. No significant differences were observed for the negative hair samples before and after the treatments; all negative samples remained negative after the treatments.

Twelve cannabinoid-positive hair samples were treated with bleach, 12 with permanent wave, 12 with dye, 12 with relaxer, and 12 with shampoo, and the results compared to the same samples without the treatments. In each case of the 12 samples treated with a type of cosmetic treatment, 6 samples were treated with one brand of a particular product and 6 other samples with a second brand. The average of the EIA B/Box 100 values obtained for the 12 positive samples in each set before treatment is shown, with the range following in parenthesis. In the second row of the table, the average of the EIA B/By x 100 values obtained for the samples in each set after treatment is shown, with the range following in parenthesis. No positive samples became negative in the EIA after the cosmetic treatments.

TreatmentStatus	Bleach	Dye	Perm	Relaxer	Shampoo
Mean (Range) of B/B0 x 100 Values of 12 Cannabinoid-Positive Samples in Cannabinoid EIA
Before	34.4 (18.2 – 54.8)	27.3 (7.9 – 54.8)	41.6 (24.8 – 61.6)	31.4 (7.9 – 63.3)	27.9 (7.9 – 54.8)
After	32.7 (10.6 – 59.6)	30.7 (13.0 – 57.3)	43.4 (20.9 – 65.4)	33.1 (13.2 – 62.2)	32.8 (15.7 – 55.1)

Contamination Study

Potential environmental contamination of samples that are identified as presumptive positive in the screening assay is addressed by GC/MS/MS confirmation analysis for the Carboxy-THC metabolite and an extensive washing procedure prior to confirmation.

Twelve hair samples ranging in color from light brown to black, with one red hair, were contaminated with smoke from a marijuana cigarette. Two days after the unwashed samples were analyzed by the Cannabinoid EIA assay and by OC/MS/MS for THC and Carboxy-THC. All of these smokecontaminated samples were positive in the Chemiluminescent Microplate EIA for Cannabinoids. No carboxy-THC was present on the hair samples using the laboratory's standard GC/MS/MS procedure, while the THC on the samples ranged from 189 - 788 ng/10 mg hair. In a report by Wilkins et al., levels of THC on unwashed hair of proven marijuana users ranged from 0.3 – 10.6 ng/10 mg hair, 2-3 orders of magnitude less than the THC contamination achieved in this experiment (J. Anal. Toxicol. 19:483, 1995)

The same smoke-contaminated samples were also washed by our standard wash procedure for marijuana presumptive positive samples, to test whether carboxy-THC could be formed during the wash procedure. No carboxy-THC was detected in the THC-contaminated samples also subjected to the wash procedure.

The same smoke-contaminated samples were also soaked for 30 minutes in water or for 30 minutes in saline, and then carried through the wash, extraction, and GC/MS/MS procedures. These saline-soaked or water-soaked samples tested positive in the EIA Cannabinoids Assay. No carboxy-THC was detected by GC/MS/MS in the THC-contaminated samples soaked in saline or water.

Wash Procedure for Cannabinoids-Presumptive Positive Samples

i. . Add 2 mL of dry isopropanol and shake in waterbath for 15 minutes at 37°C with shaking @ 100 -120 oscillations/minute. Remove isopropanol
Add 2 mL of Wash Buffer (0.01 M phosphate buffer, pH 6.0, containing 0.1 % BSA) and ii. shake in waterbath for 30 minutes at 37℃ with shaking @ 100 -120 oscillations/minute. Remove Buffer.
Repeat Step ii. two more times iii.

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Summary of Cross-reactivity and Interference Studies

Cross-reactivity of sixty-seven compounds was investigated. Seventy-five compounds were tested for interference at +/-50% of the cutoff showed no interference in the assay. The studies demonstrated the Cannabinoid EIA to be substantially equivalent with the predicate.

Stability of Calibrator and Control Solutions

The carboxy-THC calibrator and control solutions are prepared in-house by the laboratory from certified standards. Stability in methanol was shown for 1 year.

Recovery Study

Recovery of cannabinoids from hair of marijuana users was shown to be substantially equivalent to that of the predicate device.

Conclusion:

The Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair is substantially equivalent to the predicate device K011426, and the results are substantially equivalent to GC/MS/MS results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

MAY - 1 2012

PSYCHEMEDICS CORP. c/o Virginia Hill 5832 Uplander Way Culver City, CA 90230

K111929 Re:

KT11727
Trade Name: PSYCHEMEDICS MICROPLATE EIA FOR CANNABINOIDS IN HAIR

Regulation Number: 21 CFR §862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Codes: LDJ Dated: March 9, 2012 Received: March 12, 2012

Dear Ms. Hill:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occience 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 mensiale commerce prior to that have been reclassified in accordance with the provisions of Ameliuments, or to devrees mat nave oose (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosment Proxy, market the device, subject to the general approval application (1 Mr.). . The general controls provisions of the Act include conduls provisions of the Feb. "The genting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (PMA), it may of Subject to such additions (CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Farts 800 to 895. your device can be found in The 21, Courts Sogness ong Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA s issualled of a backer complies with other requirements mean that FDA has made a decemination that 5 s coninistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by sectimited to: posis of the Act of ally rederal statues and registerents, including, but not limited to: registration in You must comply with an the Hev site 21 CFR Parts 801 and 809); medical device and listing (21 CFN Part 807), labeling (21 CFR 803); and good reporting (reporting of medical device Telated adverse - ality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

signature

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number : K111929

Device Name: Psychemedics Microplate Chemiluminescent EIA for Cannabinoids in Hair

Indications For Use:

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

C.A.S

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111929

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).