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The Instant View® Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.

The Instant View® Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
The drug tests will provide a preliminary result only. A more specific. alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.

The Instant View® Multi-Drug of Abuse Urine Test Cup and the Instant View® Multi-Drug of Abuse Urine Test Panel are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to twelve individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundycolored band during the test regardless of the presence of the drug.

The provided document is a 510(k) summary for the Instant View® Multi-Drug of Abuse Urine Test Cup and Panel. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain acceptance criteria for device performance or the results of a study proving the device meets acceptance criteria.

The "Acceptance Criteria" for such a device would typically involve sensitivity, specificity, accuracy, and reproducibility in detecting the target drugs at or above specified cutoff levels. The "Study" would then present the results of clinical or laboratory testing to demonstrate that the device performs according to these criteria.

The document states:

• "The performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of this drug of abuse test are the same as the predicate device." This is a claim of equivalence but does not present the actual performance data or acceptance criteria for the current device.

Therefore, I cannot provide the requested information from the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device based on its technology, intended use, and general characteristics, rather than detailing specific performance studies with acceptance criteria for the new device.

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