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510(k) Data Aggregation
(36 days)
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl 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) |
|---|---|---|
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 or 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 or 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 or 1000 |
| MTD | Methadone | 300 |
| OPI | Morphine | 300 or 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-∆9-THC-COOH | 50 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
The single or multi-test panels can consist of up to eighteen (18) 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 Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below.
This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
|---|---|---|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | EDDP | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.
This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a dip card format. Each test device is sealed with two 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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