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The Ameditech ImmuTest™ Drug Screen AMPHETAMINE is an In Vitro Diagnostic test for the qualitative detection of Amphetamine in human urine at cut-off concentration of 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

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This is an FDA 510(k) clearance letter for the Ameditech ImmuTest™ Drug Screen Amphetamine, an in-vitro diagnostic device.
However, the document does NOT contain the detailed study information required to answer the prompt.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or their provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on a standalone performance study.
• Description of the type of ground truth used (e.g., pathology, expert consensus).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is merely the FDA's clearance stating that the device is substantially equivalent to a legally marketed predicate device. The actual study data and results would be found in the 510(k) submission itself, which is not provided here.

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