QUIKSTRIP ONESTEP MARIJUANA (THC) TEST

K963654 · Syntron Bioresearch, Inc. · LDJ · Feb 28, 1997 · Clinical Toxicology

Device Facts

• Record ID: K963654
• Device Name: QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
• Applicant: Syntron Bioresearch, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

This device is intended for medical/forensic screening of urine.

Device Story

QuikStrip™ One Step Marijuana (THC) Test; chromatographic absorbent device; lateral flow immunoassay. Input: urine sample. Principle: competitive binding; drug/metabolites in sample compete with immobilized drug conjugate for limited antibody sites; labeled antibody-dye conjugate binds free drug; complex competes with immobilized antigen in positive reaction zone. Output: visual magenta color band; absence of band at test line indicates drug presence >50 ng/ml; presence of band at control line confirms device function. Used in medical/forensic settings; operated by laboratory personnel/clinicians. Results provide preliminary screening information for clinical decision-making.

Clinical Evidence

Bench testing and clinical trial comparison. Sample size: 261 individual urine samples. Comparator: Syva Emit and GC/MS. Results: relative sensitivity 99.3%, relative specificity 1.00, concordance 99.67%. Statistical analysis showed no significant difference between the device and reference methods.

Technological Characteristics

Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; immobilized antigen conjugate. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative screening of urine for the presence of Cannabinoids and their metabolites at a detection level of 50 ng/ml.

Regulatory Classification

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 include delta-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.

Special Controls

*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).

Reference Devices

• Syva Emit
• GC/MS

Submission Summary (Full Text)

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K963654

# Summary of Safety and Effectiveness

FEB 28 1997

The sponsor Syntron Bioresearch Inc. (277 Loker Ave. West, Carlsbad, Ca., 92008) has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Cannabinoids and their metabolites in a screening format.

The Trade name of the device is QuikStrip™ One Step Marijuana (THC) Test having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. This device is intended for medical/forensic screening of urine.

Syntron's QuikStrip™ One Step Marijuana (THC) test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

The sponsor subjected the final product to both in-house testing of 261 individual urine samples using both the Syva Emit and GC/MS against the new product and an independent Clinical Trial. The calculated relative sensitivity compared to Emit was 99.3% and the calculated relative specificity against Emit was found to be 1.00 with concordance of 99.67%. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference between the reference method and the new Syntron method.

Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President of Drial Consultants Inc. at 805-522-6223 or by fax at 805-522-1526 who is Syntron's designated regulatory consultant. Specific Corporate information may be obtained from Dr. James Lee, President of Syntron Bioresearch at the address given in the first paragraph.

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