QUICKPAC II ONE STEP MARIJUANA (THC) TEST
Device Facts
| Record ID | K963207 |
|---|---|
| Device Name | QUICKPAC II ONE STEP MARIJUANA (THC) TEST |
| Applicant | Drial Consultants, Inc. |
| Product Code | LDJ · Clinical Toxicology |
| Decision Date | Feb 20, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3870 |
| Device Class | Class 2 |
Intended Use
The QuikPac II™ One Step Marijuana (THC) Test is intended for medical/forensic screening of urine for the presence of Cannabinoids and their metabolites.
Device Story
Chromatographic absorbent device for qualitative urine drug screening; detects Cannabinoids/metabolites. Principle: competitive immunoassay; drug in sample competes with immobilized drug conjugate for limited antibody sites. Labeled antibody-dye conjugate binds free drug; complex migrates up membrane. Positive result: no magenta band at test zone (drug > 50 ng/ml). Control zone: magenta band confirms reagent/device function. Used in medical/forensic settings; operated by laboratory personnel/technicians. Provides visual qualitative result to assist clinical/forensic decision-making regarding drug presence.
Clinical Evidence
Bench testing and clinical trial using 261 individual urine samples. Compared QuikPac II™ against Syva Emit and GC/MS. Results: 99.3% relative sensitivity, 100% relative specificity, 99.67% concordance. No significant statistical difference identified between device and reference methods.
Technological Characteristics
Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; immobilized antigen conjugate. Qualitative visual readout. Detection threshold: 50 ng/ml.
Indications for Use
Indicated for qualitative screening of urine for Cannabinoids and their metabolites in individuals suspected of drug use. Detection level is 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
Related Devices
- K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) · Tcpi, Inc. · Aug 20, 1996
- K992949 — SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST · Drug Detection Devices, Ltd. · Dec 27, 1999
- K963654 — QUIKSTRIP ONESTEP MARIJUANA (THC) TEST · Syntron Bioresearch, Inc. · Feb 28, 1997
- K971109 — QUIKPAC II ONE STEP AMPHETAMINE TEST · Drial Consultants, Inc. · May 14, 1997
- K973269 — QUIKSTRIP ONE STEP BENZODIAZEPINE TEST · Drial Consultants, Inc. · Feb 25, 1998
