(60 days)
The Psychemedics Microplate EIA for Oxycodone is an enzyme immunoassay (EIA) for the preliminary qualitative detection of the opiate oxycodone in human head and body hair using an oxycodone calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying oxycodone 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 oxycodone 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 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 Oxycodone. 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 oxycodone conjugated to bovine serum albumin (BSA) (patent pending), polyclonal rabbit anti-oxycodone, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (which stops the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
Acceptance Criteria and Device Performance for Psychemedics Microplate EIA for Oxycodone in Hair
The Psychemedics Microplate EIA for Oxycodone in Hair is an enzyme immunoassay for the preliminary qualitative detection of oxycodone in human head and body hair. The device's performance was evaluated through precision studies and agreement testing against LC/MS/MS confirmation.
1. Table of Acceptance Criteria and Reported Device Performance
The direct acceptance criteria for the device are not explicitly stated as numerical targets in the provided document. However, the performance is reported in terms of precision (intra-assay and inter-assay agreement at various concentrations relative to the cutoff) and agreement with the confirmatory method (LC/MS/MS). The implied acceptance criteria are high agreement percentages for both positive and negative samples around the cutoff.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision (Intra-Assay) | High agreement for negative and positive samples at various levels relative to the 2 ng/10 mg hair cutoff. | - Negative (B0, -75%, -50%, -25%): 15/15 reported as NEG |
- Positive (plus 25%, plus 50%, plus 75%, plus 100%): 15/15 reported as POS |
| Precision (Inter-Assay) | High agreement for negative and positive samples at various levels relative to the 2 ng/10 mg hair cutoff. | - Negative (B0, -75%, -50%, -25%): 75/75 reported as NEG - Positive (plus 25%, plus 50%, plus 75%, plus 100%): 75/75 reported as POS |
| Agreement with LC/MS/MS | High concordance between EIA results and LC/MS/MS confirmation, especially for samples around the cutoff. | - **47 Negative HC/MS/MS samples (
§ 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).