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The Bionexia OptiCup is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine at or above the following concentrations: | Marijuana | 50 ng/mL | |-----------------|-------------| | Cocaine | 300 ng/mL | | Phencyclidine | 25 ng/mL | | Morphine | 2,000 ng/mL | | Methamphetamine | 1,000 ng/mL | | Methadone | 300 ng/mL | | Amphetamine | 1,000 ng/mL | | Barbiturates | 300 ng/mL | | Benzodiazepines | 300 ng/mL | | Nortriptyline | 1,000 ng/mL | The Bionexia OptiCup is used to obtain visual qualitative test results and is intended for healthcare professionals only. It is not intended for over the counter sale to non-professionals. Configurations of the Bionexia OptiCup can consist of any combination of the above listed drug analytes. This device provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Bionexia OptiCup is derived from a previously FDA-cleared device, ADT's ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels (K061005). The unmodified test is made of various number of single drug-of-abuse (DOA) test strips (from 1 to 10 strips) placed in an open faced housing. These test strips are fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. When running the test, the dipping end of the test panel is dipped into urine sample and test results read at 5 minutes. The test strips used in Bionexia OptiCup are made in the exact same manner as the strips used in the cleared ACCUSTEP Single and Multi-Strip Dipstick DOA Screen Panels from one to ten single test strips placed in an open-faced housing inside a plastic cup. In Bionexia OptiCup, these test strips are assembled and fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. The dipstick assembly is then sealed, (integrated) into a plastic urine cup, which also serves as a urine collection and specimen delivering device to run the test in one integrated device. Bionexia OptiCup is a user-friendly modification of the unmodified device. To use an unmodified device, user has to collect urine sample in a container, tear open the dipstick device pouch, take off the device cover, dip the device into urine sample and hold it for 5-10 seconds, cover the dipstick device cover, lay device flat and wait for 5 minutes to read the preliminary qualitative test results. To use a modified device, user can open the cup pouch and take out the integrated OptiCup, simultaneously collect, dispense urine for dipping, run the test and obtain preliminary qualitative test results in 5 minutes. The leftover urine specimen in the cup, which is not adulterated or tampered with in any way, can be sent in to a toxicology lab for confirmation especially when a presumptive positive test result is obtained. This modified device allows user to administrate multiple drug test from urine specimen collection, testing, and result confirmation with one single device. Bionexia OptiCup presents an ideal and convenient for various testing environments such as hospitals, clinics, workplace pre-employment screening, justice system or court-ordered compliance monitoring and random drug testing. This integrated Cup is designed to accompany available line of drugs of abuse tests from ADT. Customers can choose any combination of the cleared drug of abuse tests and integrated into this cup. The Bionexia OptiCup is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine. Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriotyline in human urine at or above the following concentrations: | Marijuana | 50 ng/mL | |-----------------|-------------| | Cocaine | 300 ng/mL | | Phencyclidine | 25 ng/mL | | Morphine | 2,000 ng/mL | | Methamphetamine | 1,000 ng/mL | | Methadone | 300 ng/mL | | Amphetamine | 1,000 ng/mL | | Barbiturates | 300 ng/mL | | Benzodiazepines | 300 ng/mL | | Nortriptyline | 1,000 ng/mL | These tests can be performed without the use of an instrument. A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing Marijuana, Cocaine, Phencyclidine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.