(300 days)
The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoids in human head and body hair samples using a 11-nor-9-Carboxy- Δ'-THC calibrator at 10 pg/10 mg hair cutoff for the purpose of identifying marijuana use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Chemiluminscent Microplate EIA for Cannabinoids 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 Chromatography/Mass Spectrometry/Mass Spectrometry (GC/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 EIA screening test consists of two parts; a pre-analytical hair treatment procedure to recover the cannabinoids from the hair and the screening assay, the Psychemedics Chemiluminescent EIA for Cannabinoids in Hair. The device comprises a white microplate coated with the antigen (11-nor-9-carboxy-delta-8-tetrahydrocannabinol) conjugated to BSA, polyclonal rabbit anticannabinoid antibody, goat anti-rabbit secondary antibody conjugated to HRP (horseradish peroxidase), a chemiluminescent substrate, and platewashing buffer.
Here's a breakdown of the acceptance criteria and the study details for the Psychemedics Chemiluminescent Microplate EIA for Cannabinoids in Hair, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device and showing agreement with the confirmatory method (GC/MS/MS). While explicit percentage targets for sensitivity and specificity are not directly stated as "acceptance criteria," the performance in the agreement testing (both with the predicate and GC/MS/MS) is presented to show the device meets the regulatory requirements for substantial equivalence.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Agreement with Predicate Device (EIA vs RIA) | Low discordance with the predicate device (Psychemedics Marijuana Screening and Confirmatory Test System, K011426) for preliminary qualitative detection of cannabinoids in hair. | Out of 610 hair samples: |
- EIA Positive, Predicate Negative: 4
- EIA Negative, Predicate Positive: 2
- EIA Positive, Predicate Positive: 189
- EIA Negative, Predicate Negative: 415
**Discordance
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).