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510(k) Data Aggregation
(97 days)
SAFElife™ T-Cup Multi-Drug Urine Test Cup:
SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cutoff Level |
|---|---|
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Fentanyl (FTY) | 1 ng/mL |
| Methamphetamine (MET/mAMP) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Opiates (OPI) | 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Norfentanyl (NFTY) | 5 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL or 20 ng/mL |
| Tramadol (TRA) | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine Test Cup offers any combinations from 1 to 19 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx:
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff
concentrations and approximate detection time:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| 6-Monoacetylmorphine (6-MAM) | 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine (AMP500) | d-Amphetamine | 500 ng/mL |
| Amphetamine (AMP1000) | d-Amphetamine | 1000 ng/mL |
| Secobarbital (BAR) | Secobarbital | 300 ng/mL |
| Buprenorphine (BUP) | Buprenorphine | 10 ng/mL |
| Oxazepam (BZO) | Oxazepam | 300 ng/mL |
| Cocaine (COC150) | Benzoylecgonine | 150 ng/mL |
| Cocaine (COC300) | Benzoylecgonine | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 2-ethylidene-1,5-dimethyl-3,3-diphenyl-pyrrolidine | 300 ng/mL |
| Fentanyl (FTY) | Fentanyl | 1 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET500/mAMP500) | D(+)-Methamphetamine | 500 ng/mL |
| Methamphetamine (MET1000/mAMP1000) | D(+)-Methamphetamine | 1000 ng/mL |
| Morphine (MOP300) | Morphine | 300 ng/mL |
| Opiates (OPI2000) | Morphine | 2000 ng/mL |
| Methadone (MTD) | Methadone | 300 ng/mL |
| Norfentanyl (NFTY) | Norfentanyl | 5 ng/mL |
| Oxycodone (OXY) | Oxycodone | 100 ng/mL |
| Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
| Propoxyphene (PPX) | d-Propoxyphene | 300 ng/mL |
| Nortriptyline (TCA) | Nortriptyline | 1000 ng/mL |
| Cannabinoids (THC20) | 11-nor-Δ9-THC-9-COOH | 20 ng/mL |
| Cannabinoids (THC50) | 11-nor-Δ9-THC-9-COOH | 50 ng/mL |
| Tramadol (TRA) | Tramadol | 100 ng/mL |
SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.
The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.
SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids, 6-Monoacetylmorphine, Fentanyl, Norfentanyl, and Tramadol in human urine. Each SAFElife™ T-Cup Multi-Drug Urine Test Cup or SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx device consists of a test cup and a package insert. Each test cup is sealed with one sachet of desiccant in an aluminum pouch. SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx have a general identical design. The SAFElife™ T-Cup Multi-Drug Urine Test Cup is for over-the-counter (OTC) use and the SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is for professional use.
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