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The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. The cutoff concentrations for this panel test are as follows.

This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder).

This test is used to obtain a visual, qualitative result and is intended for professional use.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

The Ameditech ImmuTest Multi-Drug Screen BUP/PPX/COC150 is an In Vitro screen test device for the qualitative detection of multi-drugs in human urine. This test uses multiple test strips in card format (test strips are placed in a card strip holder), cassette format (test strips are placed in a cassette strip holder), and cup format (test strips are placed in a lid strip holder). This test is used to obtain a visual, qualitative result and is intended for professional use.

This document is a 510(k) clearance letter from the FDA for a multi-drug screen device. It acknowledges the device's substantial equivalence to legally marketed predicate devices. However, the provided text does not contain the acceptance criteria or a study detailing the device's performance against such criteria. It only describes the product, its intended use, and cutoff concentrations for the substances it detects.

Therefore, I cannot extract the information required in your request from the provided text.

To provide the requested details, I would need a different document that outlines a performance study, including:

• A table of acceptance criteria and reported device performance (sensitivity, specificity, accuracy, etc.)
• Details on sample size, data provenance, ground truth establishment, and expert qualifications.

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