(120 days)
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.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).