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Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels: Amphetamine 1000 ng/mL Amphetamine 500 ng/mL Methamphetamine 1000 ng/mL Methamphetamine 500 ng/mL 3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL 3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL Buprenorphine 12.5 ng/mL Benzodiazepines (Oxazepam) 300 ng/mL Barbiturates (Butalbital) 300 ng/mL Oxycodone 100 ng/mL Methadone 300 ng/mL Phencyclidine 25 ng/mL Propoxyphene 300 ng/mL Opiates 300 ng/mL Opiates 2000 ng/mL Cocaine (Benzoylecgonine) 300 ng/mL Cocaine (Benzoylecgonine) 150 ng/mL Tricyclic Antidepressants (Nortriptyiline) 1000 ng/mL THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) 50 ng/mL 'Rapid Tox Cup' is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS). The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results. There is no calibration necessary and therefore no calibrator needed for this device. 'Rapid Tox Cup' provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.

The immunoassays employed in each test strip of the 'Rapid Tox Cup' are based on the same principle of the highly specific reaction between antigens and antibodies. Each assay consists of a membrane strip onto which up to five different drug conjugates have been immobilized. A colloidal gold-antibody complex consisting of up to five antibodies is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-multi-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur forming a visible line in all "test" areas. The formation of a visible line in the test areas occur when the test is negative for the adjacent labeled drug. When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody binding sites on the colloidal gold-labeled antibody complex, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a colored line in any of the test areas is indicative of a presumptive positive result. A control line, comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of a drug in the urine, and therefore, should be present in all reactions. A negative urine will produce up to six colored lines, and a positive sample will produce a colored line in the control area and no colored line(s) in the test area corresponding to the individual analyte(s) that are present in the sample. The device is contained in a polypropylene cup.

Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolite, THC metabolite, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in screening of abuse samples. The detecting cut-off concentrations are as follows: | MET | D-Methamphetamine | 1000 ng/ml | |----------------|-----------------------------|------------| | OPI | Morphine | 300 ng/ml | | COC | Benzoylecgonine | 300 ng/ml | | THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/ml | | PCP | Phencyclidine | 25 ng/ml | | Benzodiazepine | Oxazepam | 300 ng/ml | | Barbiturate | Secobarbital | 300 ng/ml | | Methadone | Methadone | 300 ng/ml | | TCA | Nortriptyline | 1000 ng/ml | | AMP | D-Amphetamine | 1000 ng/ml | This assay provides only a preliminary analytical test result. A more specific alternate chemical method m ust be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/ MS)/High performance liquid chromatography (HPLC, for TCA) are the preferred confirmatory methods. Cl inical consideration and professional judgment should be applied to any drug of abuse test result, particula rly when preliminary positive results are obtained.

The AccuSign® RCDOA 10 test device is a simple immuno-chromatographic test for the rapid, qualitative detection of methamphetamine, opiates, cocaine, THC, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, amphetamine and/or their metabolites in human urine. The test result can be read visually or with DXpress reader (k050955).

Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressans, methadone, and amphetamine in human urine to assist in the screening of drugs of abuse samples. The detection cut-off concentrations are as follows: | MET | d-Methamphetamine | 1000 ng/mL | |----------------|-----------------------------|------------| | OPI | Morphine | 300 ng/mL | | COC | Benzoylecgonine | 300 ng/mL | | THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL | | PCP | Phencyclidine | 25 ng/mL | | Benzodiazepine | Oxazepam | 300 ng/mL | | Barbiturate | Secobarbital | 300 ng/mL | | Methadone | Methadone | 300 ng/mL | | TCA | Nortriptyline | 1000 ng/mL | | Amphetamine | d-Amphetamine | 1000 ng/mL |

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Immunoassay for the qualitative detection of methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows: | MET | D-Methamphetamine | 1000 ng/mL | |----------------|------------------------------|------------| | OPI | Morphine | 300 ng/mL | | COC | Benzoylecgonine | 300 ng/mL | | THC | 11-nor-Δ 9-9-carboxylic acid | 50 ng/mL | | PCP | Phencyclidine | 25 ng/mL | | Benzodiazepine | Oxazepam | 300 ng/mL | | Barbiturate | Secobarbital | 300 ng/mL | | Methadone | Methadone | 300 ng/mL | | TCA | Nortriptyline | 1000 ng/mL |

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