(222 days)
Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only.
This assay provides only preliminary results. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.
Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL.
The provided text is an FDA 510(k) clearance letter for the Acro Rapid Methamphetamine Urine Test. It includes the device name, regulation information, significant equivalence determination, and indications for use. However, it does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or other specifics of performance testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a clearance letter, not a performance study report.
§ 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).