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The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is intended for use in clinical and forensic laboratories when used in conjunction with the Cozart® RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for amphetamines in human oral fluid at a cutoff concentration of 15ng/ml. This is equal to 45ng/ml in neat oral fluid as the collection system involves a 1:3 dilution of the sample.

This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GCMS) is the preferred confirmatory method.

The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a laboratory based test for the detection of amphetamines in human oral fluid using a cutoff equivalent to 45ng/mL. The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS).

As can be seen from the Principle of the Test section in the pack insert, the Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a competitive ELISA for the detection of amphetamines in human oral fluid.

The Cozart® EIA Amphetamines Oral Fluid Microplate kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 2, 15 and 50ng/ml amphetamine in oral fluid matrix).

Here's an analysis of the provided text, outlining the acceptance criteria and the study data, as requested:

Acceptance Criteria and Device Performance Study for Cozart® EIA Amphetamines Oral Fluid Microplate Kit

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct thresholds in the provided document. Instead, the document presents comparison data against a "gold standard" (GC/MS) and a predicate device. Based on the performance reported, an implicit acceptance criterion can be inferred as achieving a high agreement with GC/MS. The precision (CV%) is explicitly stated as acceptable if below 10%.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 163 samples.
• Data Provenance: Not explicitly stated regarding country of origin or whether the data was retrospective or prospective. However, the context suggests these were human oral fluid samples collected for "clinical and forensic samples" for the purpose of this study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus for this type of test.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth was established by GC/MS, an objective chemical analysis method, not by human experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an immunoassay (ELISA) for detecting amphetamines. It is a laboratory-based automated or semi-automated test, not a medical imaging or diagnostic device requiring human reader interpretation, nor does it involve AI assistance in the context of human reader improvement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance study describes the standalone performance of the Cozart® EIA Amphetamines Oral Fluid Microplate Kit. The device (kit) was tested independently, and its results were compared directly against GC/MS. There is no human-in-the-loop component mentioned that would alter the device's output.

7. The Type of Ground Truth Used

The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method." and "The Cozart® EIA Amphetamines Oral Fluid Microplate Kit was compared to Gas Chromatography/Mass Spectrometry (GC/MS)."

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or its size. The 163 samples described were used for the performance comparison study, which assesses the device's accuracy against the ground truth. As this is an immunoassay kit, not a machine learning algorithm that typically requires a large training set, the concept of a training set in this context is less relevant in the same way it would be for AI/ML device submissions. The kit would have been developed and optimized through internal R&D, but specific training set data is not typically disclosed in 510(k) summaries for such devices.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is explicitly mentioned for the reported comparison study (see #8), this question is not directly applicable. If a training set were implied for the kit's development, its ground truth would also presumably be established by highly accurate confirmatory methods like GC/MS.

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