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510(k) Data Aggregation
K Number
K201228Device Name
Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
Manufacturer
Psychemedics Corporation
Date Cleared
2021-06-25
(414 days)
Product Code
JXO
Regulation Number
862.3250Why did this record match?
Product Code :
JXO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Psychemedics homogeneous enzyme immunoassay for cocaine in hair is an enzyme immunoassay for the preliminary qualitative detection of cocaine in human head and body hair using a cocaine calibrator of 5 ng/10 mg hair for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use and not for sale to anyone.
The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test results, a more specific alternate chemical method (e.g. LC/MS/MS) must be used. Clinical consideration and professional judgement should be applied to the interpretation of any drug-of-abuse test result.
Device Description
The homogeneous enzyme immunoassay (HEIA) test consists of two parts; a pre-analytical hair treatment procedure (to extract cocaine from the solid hair matrix to a measurable liquid matrix) and the screening assay, the Psychemedics Cocaine HEIA. The screening portion of the test system is based on competition for antibody binding sites between drug in the measurable liquid matrix and drug-labeled recombinant glucose-6-phosphate dehydrogenase (G6PDH). As the antibody binds labeled G6PDH, enzyme activity decreases. In the presence of drug, enzyme activity increases in direct proportion to the drug concentration. Active enzyme reduces nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically.
The Psychemedics Cocaine HEIA consists of reagents R1 (anti-cocaine monoclonal antibody with substrate) and R2 (cocaine labeled recombinant G6PDH).
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K Number
K111925Device Name
PSYCHEMEDICS COCAINE EIA
Manufacturer
PSYCHEMEDICS CORP.
Date Cleared
2012-05-01
(300 days)
Product Code
JXO, DEV
Regulation Number
862.3250Why did this record match?
Product Code :
JXO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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