(300 days)
The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine in human head and body hair samples using a cocaine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use only and not for sale to anyone.
The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GC/MS) must be used. Clinical consideration and professional judgment should 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 Cocaine. 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 benzoylecgonine conjugated to bovine serum albumin (BSA) (patent pending), monoclonal mouse anti-cocaine, goat anti-mouse 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.
Acceptance Criteria and Study for Psychemedics Microplate EIA for Cocaine in Hair
The Psychemedics Microplate EIA for Cocaine in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and its metabolites in human head and body hair. The device's performance was evaluated against a predicate device (Psychemedics Cocaine Assay, K010868) and confirmed by LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry).
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state pre-defined acceptance criteria for the accuracy of the new device relative to the predicate or LC/MS/MS. However, the study aims to demonstrate "substantial equivalence" to the predicate and "substantially equivalent" results to LC/MS/MS. Based on the presented data, the implicit acceptance criteria appear to be:
- High agreement with the predicate device.
- High agreement with LC/MS/MS for confirmed samples.
- No significant impact of cosmetic treatments on negative or positive samples.
- Effective wash procedure to mitigate external contamination.
- Stability of calibrator and control solutions.
- Cross-reactivity within acceptable limits for related compounds, and minimal to no cross-reactivity or interference from other common compounds.
- Equivalent recovery to the predicate device.
Here's a summary of the reported device performance against these implicit criteria:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Agreement with Predicate Device | Four hundred-twenty-five hair samples were compared. Cutoff", and 12 samples for "≥ Cutoff, And |
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).