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510(k) Data Aggregation
K Number
K232228Device Name
Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
Manufacturer
Shanghai Accurature Diagnostics Co., Ltd.
Date Cleared
2024-02-23
(211 days)
Product Code
DJG, DIO, DIS, DJR, DKZ, JXM, JXN, LAF, LCM, LDJ
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Accurature Diagnostics Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Accurature Multi-drug Urine Test Cup and Accurature Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|--------------------------------|--------------|-----------|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Opzaepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Accurature Multi-drug Urine Test Cup and Accurature Multi-drug UrineTest Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital and Oxycodone 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.
For over-the-counter use.
Multi-drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Marijuana in human urine at the cut off concentrations of:
| Drug | Abbreviation | Cut-off |
|--------------------------------|--------------|-----------|
| Amphetamine | AMP | 1000ng/mL |
| Secobarbital | BAR | 300 ng/mL |
| Buprenorphine | BUP | 10 ng/mL |
| Opzaepam | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methylenedioxy-methamphetamine | MDMA | 500 ng/mL |
| Methamphetamine | MET | 1000ng/mL |
| Morphine | MOR | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Marijuana | THC | 50 ng/mL |
Configuration of the Multi-drug Urine Test Cup and Multi-drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam Secobarbital and Oxycodone 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.
For prescription use only.
Device Description
The subject device will be sold in two formats: Multi-drug Urine Test Dip Card and Multi-drug Urine Test Cup. Multi-Drug Urine Test Cup and Multi-drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Multi-Drug Urine Test devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Marijuana, Cocaine, Methamphetamine, Morphine, Oxazepam, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
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