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510(k) Data Aggregation
(30 days)
The VINScreen Urine Drug Test Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:
| Abbreviation | Analyte | Calibrator | Cut-off (ng/mL) |
|---|---|---|---|
| 6AM | 6-Acetylmorphine | 6-Monoacetylmorphine | 10 |
| AMP | Amphetamine | d-Amphetamine | 500 or 1000 |
| BAR | Secobarbital | Secobarbital | 300 |
| BUP | Buprenorphine | Buprenorphine | 10 |
| BZO | Oxazepam | Oxazepam | 300 |
| COC | Cocaine | Benzoylecgonine | 150 or 300 |
| EDDP | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| FEN | Fentanyl | Fentanyl | 1 |
| FEN | Norfentanyl | Norfentanyl | 5 |
| MDMA | Ecstasy | d,l-Methylenedioxymethamphetamine | 500 |
| MET | Methamphetamine | d-Methamphetamine | 500 or 1000 |
| MOR | Morphine | Morphine | 300 |
| MTD | Methadone | d/l-Methadone | 300 |
| OPI | Opiates | Morphine | 2000 |
| OXY | Oxycodone | Oxycodone | 100 |
| PCP | Phencyclidine | Phencyclidine | 25 |
| PPX | Propoxyphene | Propoxyphene | 300 |
| TCA | Nortriptyline | Nortriptyline | 1000 |
| THC | Marijuana | 11-nor-Δ9-THC-9 COOH | 20 or 50 |
The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.
This in vitro diagnostic device provides only a preliminary test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.
The VINScreen Urine Drug Home Test Cup is lateral flow immunoassays for rapid detection of multiple commonly abused drugs in human urine. The detectable drugs and their cutoff concentrations are listed below:
| Drug | Cut-off (ng/mL) | Abbreviation |
|---|---|---|
| 6-monoacetylmorphine | 10 | 6AM |
| Amphetamine | 500 / 1000 | AMP |
| Secobarbital | 300 | BAR |
| Buprenorphine | 10 | BUP |
| Oxazepam | 300 | BZO |
| Cocaine | 150 / 300 | COC |
| EDDP | 300 | EDDP |
| Fentanyl | 1 | FEN |
| Norfentanyl | 5 | FEN |
| Ecstasy | 500 | MDMA |
| Methamphetamine | 500 / 1000 | MET |
| Methadone | 300 | MTD |
| Opiates | 300 / 2000 | MOR/OPI |
| Oxycodone | 100 | OXY |
| Phencyclidine | 25 | PCP |
| Propoxyphene | 300 | PPX |
| Nortriptyline | 1000 | TCA |
| Marijuana | 20 / 50 | THC |
The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device.
This device provides only a preliminary test result. A more specific alternate method must be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.
VINScreen Urine Drug Test Cup and VINScreen Urine Drug Home Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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