Search Results
Found 1 results
510(k) Data Aggregation
(34 days)
The WEBEST Multi-Drug Urine Cup is a rapid lateral flow immunoassays for the qualitative detection of D-Amphetamine, Butalbital, Buprenorphine, Oxazepam, Benzoylecgonine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Fentanyl, Methylenedioxymethamphetamine, D-Methamphetamine, Methadone, 6-Monoacetylmorphine, Norfentanyl, Morphine, Oxycodone, Phencyclidine, D-Propoxyphene, Nortriptyline, 11-nor-Δ9-THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/ml) |
|---|---|---|
| AMP | D-Amphetamine | 1000 or 500 |
| BAR | Butalbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 300 or 150 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| FYL | Fentanyl | 1 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | D-Methamphetamine | 1000 or 500 |
| MTD | Methadone | 300 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
| NFYL | Norfentanyl | 5 |
| MOP/OPI | Morphine | 2000 or 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | D-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
| TML | Tramadol | 100 |
The single or multi-test cup can consist of up to nineteen (19) of the above listed analytes in any combination with or without on-board adulteration/ specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Webest Home Multi-Drug Urine 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:
| CODE | SUBSTANCE | CUT-OFF (ng/ml) |
|---|---|---|
| AMP | D-Amphetamine | 1000 or 500 |
| BAR | Butalbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 300 or150 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine | 300 |
| FYL | Fentanyl | 1 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | D-Methamphetamine | 1000 or 500 |
| MTD | Methadone | 300 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
| NFYL | Norfentanyl | 5 |
| MOP/OPI | Morphine | 2000 or300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | D-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-Δ9-THC-COOH | 50 |
| TML | Tramadol | 100 |
This is not a screening device to monitor prescription medication.
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 shall be used in order to obtain a confirmed analytical test result. GC/MS or LC/MS is the preferred confirmatory method.
Webest Multi-Drug Urine Cup and Webest Home Multi-Drug Urine 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.
N/A
Ask a specific question about this device
Page 1 of 1