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Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine at the cutoff concentrations of.

Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam. Secobarbital and Oxyodone 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The provided document is a 510(k) premarket notification for the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain a detailed study report with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or adjudication methods for performance evaluation.

The document states: "Verification studies were conducted in support of the modification to have a multi-drug test cup and test card test, including interference studies and a lay-user study. Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates." This indicates that studies were performed, but their details are not included in this FDA letter.

Therefore, I cannot provide the requested information from the given text alone. The document mentions that the new devices are considered substantially equivalent to existing predicate devices based on "acceptable performance characteristics", but does not elaborate on what those characteristics or the detailed performance results are.

To answer your request, a full study report from Healgen Scientific LLC detailing the performance characteristics and the supporting data would be necessary.

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