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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.

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).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

Indications for Use: Preliminary qualitative detection of cocaine in human head and body hair using a cocaine calibrator of 5 ng/10 mg hair, for identifying cocaine use. Intended for in-house professional use only. Positive results require confirmation with a more specific alternate chemical method (e.g., LC/MS/MS).

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with specific pass/fail metrics in a table format. Instead, it details various performance studies and their results to demonstrate substantial equivalence to a predicate device. I've extracted the relevant performance metrics and will organize them as an "acceptance criteria" table for clarity, inferring the implied acceptance for each from the reported results ("all good", "no cross-reactivity", "remained positive/negative").

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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:

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