MICRO-STRIP FOR AMPHETAMINE METABOLITES

• K Number: K974611
• Device Name: MICRO-STRIP FOR AMPHETAMINE METABOLITES
• Manufacturer: MICRODIAGNOSTICS, INC.
• Date Cleared: 1998-03-20 ( 99 days)
• Product Code: DKZ
• Regulation Number: 862.3100
• Type: Traditional
• Panel: TX
• Reference & Predicate Devices: N/A

Intended Use

The Microdiagnostics, Inc. Micro-Strip for Amphetamine Metabolites is intended to qualitatively detect the metabolites of Amphetamine and Amphetamine-like drugs in urine.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a government document (FDA approval letter) and does not contain the specific information needed to answer your request regarding acceptance criteria and a study proving device performance. The document confirms that the "Micro-Strip for Amphetamine Metabolites" device is substantially equivalent to legally marketed predicate devices, but it does not detail the performance study, acceptance criteria, or other requested metrics.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness study.
6. Information on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Regulation Number and Section

§ 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).