(300 days)
The Psychemedics Microplate EIA for Methamphetamine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human head and body hair samples using a methamphetamine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying methamphetamine use. This product is intended exclusively for inhouse professional use only and is not for sale to anyone.
The Psychemedics Microplate EIA for Methamphetamine in Hair provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgment must be applied to the interpretation of any drug-of-abuse test result.
The test consists of two parts: a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Methamphetamine. The drug is recovered from the hair using a patented method (U.S. Patent #8,084,215).The screening portion of the test system consists of (1) microplate wells coated with multiple drugs including methamphetamine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-methamphetamine, rabbit anti-goat secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCI to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
The provided document describes the Psychemedics Microplate EIA for Methamphetamine in Hair, an enzyme immunoassay (EIA) for the preliminary qualitative detection of methamphetamine in human hair samples. The study aims to demonstrate substantial equivalence to a predicate device (Psychemedics Methamphetamine and MDMA Assay, K011185) and alignment with LC/MS/MS results.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a formal table format. However, it presents performance data that implies the criteria for the device to be considered substantially equivalent and perform adequately. Based on the provided "Agreement Testing" section, we can infer the following:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Agreement with Predicate | Low discordance with the predicate device. A high percentage of agreement for both negative and positive results compared to the predicate. | * Discordance between EIA and RIA (predicate) was |
§ 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).