(126 days)
The Microdiagnostics, Inc. D&V The Microdiagnostics, Inc. Distincts the metabolit The Microdiagnostics, Inc. barge of detects the metabolites is an immunoassay that quartiallery oceates and Phencyclidine of Amphecamine, Gocaine, Massystems in human urine at the SAMHSA cutoff levels. This test is intended for professional use only.
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The provided text describes a 510(k) premarket notification for a "Multi-Test Strip" device for detecting drugs of abuse in human urine. However, it does not contain any information regarding acceptance criteria, study results, sample sizes (for test or training sets), expert qualifications, ground truth methods, or MRMC studies.
The document is a letter from the FDA to Microdiagnostics, Inc., confirming the substantial equivalence of their device to legally marketed predicate devices. It lists the device's indications for use and regulatory classifications but does not detail the internal validation studies performed by the manufacturer to establish performance.
Therefore, I cannot provide the requested information based on the input text.
§ 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).