(300 days)
The Psychemedics Microplate EIA for Opiates is an enzyme immunoassay (EIA) for the preliminary qualitative detection of opiates in human head and body hair using a morphine calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying opiate use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Microplate EIA opiate assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
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 Opiates. 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 morphine conjugated to bovine serum albumin (BSA) (patent pending), polyclonal sheep anti-morphine, rabbit anti-goat secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)}, HCl to acidify the final reaction, and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
The provided text describes the performance testing of the Psychemedics Microplate EIA for Opiates in Hair. However, it does not explicitly state "acceptance criteria" as a separate, pre-defined set of metrics. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Psychemedics RIA Assay for Opiates) and correlation with a confirmatory method (LC/MS/MS).
The "acceptance criteria" can be inferred from the reported performance results, particularly the low discordance with the predicate device and the high agreement with LC/MS/MS, especially for confirmed positive and negative samples.
Here's an analysis of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
Inferred Acceptance Criteria:
- Low discordance with predicate device (RIA Assay for Opiates): The device should show strong agreement with the established predicate method.
- High agreement with LC/MS/MS confirmation: For definitive positive and negative cases, the EIA result should align with the LC/MS/MS results.
- Robustness to cosmetic treatments: Cosmetic treatments should not significantly alter the test results for both negative and positive samples.
- Effective contamination control: The wash procedure should effectively remove external contamination, preventing false positives.
- Limited cross-reactivity and no interference: The assay should be specific to opiates and not significantly affected by common interfering substances.
Reported Device Performance:
| Performance Metric | Reported Device Performance |
|---|---|
| Discordance with Predicate (RIA Assay) |
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).