(98 days)
The Ameditech ImmuTest™ Drug Screen METHAMPHETAMINE is an In Vitro screen test for the qualitative detection of Methamphetamine in human urine at cut-off concentration of 500 ng/ml.
This test kit is used to obtain a visual, qualitative result and is intended for professional use.
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The provided text is a 510(k) clearance letter from the FDA for the "Ameditech ImmuTest™ Drug Screen METHAMPHETAMINE." This document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/device performance study.
The document is a legal notification that the device has been found substantially equivalent to a predicate device and can be marketed. It defines the device name, regulation number, regulatory class, and product code, along with its indications for use (qualitative detection of Methamphetamine in human urine at a cut-off concentration of 500 ng/ml).
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§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).