SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
Device Facts
| Record ID | K181968 |
|---|---|
| Device Name | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card |
| Applicant | Safecare Biotech (Hangzhou) Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Aug 20, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine 1000 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Cannabinoids 50 ng/mL Methamphetamine 1000 ng/mL Morphine 2000 ng/mL Secobarbital 300 ng/mL Methadone 300 ng/mL Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use. SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cannabinoids, Methamphetamine, Morphine, Secobarbital and Methadone in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine 1000 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Cannabinoids 50 ng/mL Methamphetamine 1000 ng/mL Morphine 2000 ng/mL Secobarbital 300 ng/mL Methadone 300 ng/mL Configuration of SAFECARE® Multi-Drug Urine Test Cup combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Oxazepam and Secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.
Device Story
Single-use in vitro diagnostic lateral flow immunochromatographic assays; detects drugs of abuse in human urine. Input: urine sample; mechanism: competitive binding lateral flow; target drugs compete with drug-conjugate for limited monoclonal antibody binding sites. Output: visual colored line in test region (negative) or absence of line (positive); control line indicates proper function. Used in home/point-of-care settings by lay users. Results are preliminary; require professional clinical judgment and confirmatory testing via GC/MS or LC/MS. Benefits patient by providing rapid, accessible preliminary screening for drug presence.
Clinical Evidence
Bench testing only. Performance validated via precision studies (25 days, two runs/day), interference testing with physiological/pathological substances, specificity/cross-reactivity analysis, and method comparison against LC/MS (80 clinical samples per drug). Lay-user study (n=240 per format) confirmed accuracy across diverse demographics and ease of use (Flesch-Kincaid Grade Level 7).
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: Dip Card or Cup. Single-use. Stable at 4-30°C for 24 months. No electronic components or software algorithms.
Indications for Use
Indicated for qualitative, simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, and Methadone in human urine for over-the-counter use. Intended for preliminary screening; requires confirmatory testing (GC/MS or LC/MS). Not for distinguishing between prescription use and abuse.
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).
