ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
Device Facts
| Record ID | K970265 |
|---|---|
| Device Name | ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST |
| Applicant | Drial Consultants, Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Apr 8, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
This device is intended for professional medical/forensic screening of urine for Methamphetamine.
Device Story
Chromatographic absorbent device for qualitative urine screening; detects Methamphetamine and metabolites. Principle: competitive immunoassay; drug in sample competes with immobilized drug conjugate on porous membrane for limited antibody sites. Sample flow carries labeled antibody-dye conjugate; binds free drug to form antibody-antigen complex. Positive result (drug >500 ng/ml): no magenta band in reaction zone. Negative result: magenta band appears. Control zone: unbound dye conjugate binds reagent to confirm device function. Used in professional medical/forensic settings by clinicians/technicians. Provides rapid screening results to assist in identifying potential drug use; requires confirmatory testing for definitive diagnosis.
Clinical Evidence
Clinical trial of 300 urine samples compared against GC/MS. Results: positive agreement 1.00; negative agreement 0.948; overall concordance 97.24%; accuracy 94.67%. Initial testing against Sigma SIA™ showed 1.00 sensitivity/specificity and 100% concordance. False positives noted with ephedrine and phenylpropanolamine.
Technological Characteristics
Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; competitive immunoassay principle. Qualitative visual readout (magenta color bands). No electronic components, software, or external energy source required.
Indications for Use
Indicated for professional medical and forensic screening of human urine to detect Methamphetamine and its metabolites at a cutoff concentration of 500 ng/ml. Contraindicated for use when ephedrine or phenylpropanolamine are present, as these may cause false positive results.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine 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
- Sigma SIA™
Related Devices
- K970724 — QUICKPAC II ONE STEP METHAMPHETAMINE TEST · Drial Consultants, Inc. · May 13, 1997
- K970395 — QUIKSTRIP ONE STEP METHAMPHETAMINE · Drial Consultants, Inc. · Jun 26, 1997
- K981197 — ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST · Tcpi, Inc. · Jun 16, 1998
- 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
