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The Snap-Top Split Key Cup for use with the GenPrime Drugs of Abuse (DOA) Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test cannot be read visually and must be used with the GenPrime DOA Reader. The Snap-Top Split Key Cup qualitatively detects drug classes in human urine at the cutoff concentrations shown below: - Test/ Calibrated to /Cutoff Amphetamines/ d-Amphetamine/ 500 ng/mL Barbiturates/ Secobarbital/ 300 ng/mL Benzodiazepines/ Oxazapam/ 300 ng/mL Cocaine/ Benzoylecgonine/ 150 ng/mL Methamphetamine/ d-Methamphetamine/ 500 ng/mL Methadone/ Methadone/ 300 ng/mL Morphine/ Morphine/ 300 ng/mL Morphine 2000/ Morphine/ 2000 ng/mL Oxycodone/ Oxycodone/ 100 ng/mL Phencyclidine/ Phencyclidine/ 25 ng/mL Marijuana/ Delta-9-THC-COOH/ 50 ng/mL Configurations of the Snap-Top Split Key Cup may consist of any combination of the above listed drug analytes. The Snap-Top Split Key Cup provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high resolution flatbed scanner, customized GenPrime DOA Reader Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The System is intended for use with the Snap-Top Split Key Cup, which is a rapid, single use, disposable immunochromatographic test for the qualitative detection of drugs of abuse in human urine (K130082). This description is limited to the Snap-Top Split Key Cup (SK Cup), with 3 additional drugs being added, giving 11 total drugs. The Snap-Top SK cup contains up to five (5) test strips embedded in a urine sample cup, containing a total of up to 11 drug test lines (between one and four drug test lines per test strip). Different drug configurations may be used. Each test strip has an internal control line to confirm validity of the test results. The Snap-Top SK Cup Drugs of Abuse Test devices are run in the GenPrime DOA Reader System according to their specific instructions for use. At the conclusion of the test (5 minutes) an image is captured and the software algorithm determines whether the colored test lines for each analyte are above or below the threshold associated with a negative or positive result. The software also confirms the validity of the results by verifying the presence of control lines. The results are recorded and logged into a database along with an image of the test, patient and operator information and the time of image capture. The results can be viewed, printed, or sent to a recipient via email or other electronic method. The GenPrime DOA Reader is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually. All analytes on the Snap-Top SK Cup for use with the GenPrime DOA Reader System were previously cleared (K130082) except for the drug tests for benzodiazepines, cocaine and barbiturates.

The GenPrime Drugs of Abuse (DOA) Reader System consists of the GenPrime DOA Reader, GenPrime DOA Windows compatible software and compatible qualitative immunochromatographic, OS Cup and Split Key Cup (SK Cup) test devices. The GenPrime DOA Reader System is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The GenPrime DOA Reader System test devices cannot be read visually. The GenPrime DOA Reader and compatible DOA test devices qualitatively detect drug classes in human urine at the cutoff concentrations shown below: OS Cun | AMP | Amphetamine (d-Amphetamine) | 500 ng/mL | |---|---|---| | BAR | Barbiturates (Secobarbital) | 300 ng/mL | | COC | Cocaine (Benzoylecgonine) | 150 ng/mL | | MET | Methamphetamine (d-Methamphetamine) | 500 ng/mL | | THC | Marijuana (Delta-9-THC-COOH) | 50 ng/mL | SK Cup | AMP | Amphetamine (d-Amphetamine) | 500 ng/mL | |---|---|---| | MET | Methamphetamine (d-Methamphetamine) | 500 ng/mL | | MTD | Methadone | 300 ng/mL | | MOP 300 | Morphine | 300 ng/mL | | MOP 2000 | Morphine | 2000 ng/mL | | OXY | Oxycodone (Oxycodone) | 100 ng/mL | | PCP | Phencyclidine (Phencyclidine) | 25 ng/mL | | THC | Marijuana (Delta-9-THC-COOH) | 50 ng/mL | Configurations of the OS Cup and SK Cup may consist of any combination of the above listed drug analytes associated with the respective cup. The GenPrime DOA reader system provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GCMS), high performance liquid chromatography (HPLC) or liquid chromatography / mass spectronetry (LCMS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The GenPrime Drugs of Abuse (DOA) Reader System consists of a small, portable high resolution flat bed scanner, customized GenPrime DOA Reader Software, and lateral flow tests that are intended for use in the system. The scanner has a custom Scanner Lid with an opening for the test device, and a Scanner Stand, which places the scanner bed at the appropriate angle for running and reading the test devices. The System is currently intended for use with two test devices, the OS Cup and the Split Key Cup, both of which are rapid, single use, disposable immunochromatographic tests for the qualitative detection of drugs of abuse in human urine. An image of a compatible test device is captured and the software algorithm determines from the image whether the presence or absence of colored test lines is associated with a positive or negative result for each analyte on a test format. The software also confirms the validity of the results by verifying the presence of control lines. The results are recorded and logged into a database along with an image of the test, patient and operator information and the time of image capture. The results can be viewed, printed, or sent to a recipient via email or other electronic method. The GenPrime DOA Reader is for in vitro diagnostic use and is intended for use in laboratories, point-of-care sites and workplaces by minimally trained users. The test is not intended for over-the-counter use.