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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%.

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The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/ml. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.

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 (GC/MS) is the preferred confirmatory method.

The Cozart EIA Cotinine Urine Kit test is a competitive ELISA for the detection of Cotinine in human urine. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 50, 500 and 5000ng/ml Cotinine in human urine).

Here's a breakdown of the acceptance criteria and the study details for the Cozart EIA Cotinine Urine Kit, based on the provided text:

Acceptance Criteria and Device Performance

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The Cozart EIA Cocaine Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for cocaine and metabolites in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/ml. in undiluted 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 (GC/MS) is the preferred confirmatory method.

The Cozart EIA Cocaine Oral Fluid Kit is a laboratory based test for the detection of cocaine and metabolites in human oral fluid using a cutoff equivalent to 30ng/mL. The Cozart EIA Cocaine Oral Fluid Kit is a competitive ELISA for the detection of cocaine and its metabolites in human oral fluid. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 5, 10 and 50ng/ml benzoylecgonine in oral fluid matrix).

Here's a summary of the acceptance criteria and study details for the Cozart EIA Cocaine Oral Fluid Kit, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 177 samples.
   • Data Provenance: Not explicitly stated, but the context of clinical and forensic samples suggests human samples. The country of origin is not specified, but the manufacturer is based in the UK. The study appears to be retrospective, as existing samples were tested.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not applicable for this type of in-vitro diagnostic (IVD) device. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical method, not human expert consensus, for drug detection.

3. Adjudication Method for the Test Set:

   • Not applicable. The reference method (GC/MS) served as the definitive ground truth, and the device's results were compared directly to it. There was no mention of human adjudication between different readers or methods beyond the GC/MS.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC study was not done. This device is an in-vitro diagnostic kit, not an imaging or diagnostic algorithm requiring human interpretation of output.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, this was a standalone performance study. The Cozart EIA Cocaine Oral Fluid Kit is a laboratory-based test that provides a qualitative result based on its biochemical reactions and spectrophotometric reading. Its performance was evaluated directly against GC/MS without human intervention in the interpretation of the kit's results.

6. The Type of Ground Truth Used:

   • analytical reference method, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The text explicitly states: "The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS)." and "96% overall agreement as compared with GC/MS". GC/MS is widely considered the "gold standard" for confirmatory drug testing.

7. Sample Size for the Training Set:

   • Not explicitly stated. The document describes a "method comparison" study as the primary performance evaluation. For a competitive ELISA kit, internal calibration and validation (which might involve a "training" equivalent) would have been performed by the manufacturer during its development, but details regarding a distinct "training set" sample size are not provided in this 510(k) summary.

8. How the Ground Truth for the Training Set Was Established:

   • Not explicitly stated. Given that performance for the test set was established against GC/MS, it is highly probable that any internal development, calibration, or "training" (if applicable for this type of device) would also have referenced GC/MS or highly purified standards of cocaine and its metabolites at known concentrations.

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The Cozart EIA Opiates Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for Opiates in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/mL in undiluted 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 (GC/MS) is the preferred confirmatory method.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Cozart Bioscience Ltd. regarding the Cozart EIA Opiate Oral Fluid Kit. This letter confirms that the device has been found substantially equivalent to legally marketed predicate devices.

However, this document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. It primarily focuses on the regulatory approval process and the device's indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, and study methodologies from this specific document. The letter itself does not detail the technical studies or their results, but rather refers to them implicitly by stating that the device has met the requirements for substantial equivalence.

To answer your request, I would need access to the actual 510(k) submission and the studies referenced within it.

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The Cozart RapiScan Oral Fluid Drug Test System - Opiates and Methadone is intended for Point of Care testing in a number of settings such as prescription workplace, drug dependency clinics, and criminal justice. It provides qualitative screening results for opiates and methadone in human oral fluid at a cut-off concentration equivalent to 40ng/mL and 30ng/mL respectively in neat oral fluid. The cozart collection system involves a 1:3 dilution of the oral fluid sample, this dilution factor is corrected for in the Cozart RapiScan Drug Test and therefore the remainder of this document will refer to the cut-offs as 13ng/mL for opiates and 10ng/ml for methadone.

This kit has to be used in conjunction with the Cozart RapiScan instrument. Please refer to the sampling and testing procedures in the instructions for use leaflet.

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 (GC/MS) is the preferred confirmatory method.

It is the responsibility of those organisations required to follow department of transportation (DOT) or the Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing guidelines to determine that this product satisfies the criteria for workplace testing established under DOT and SAMHSA.

The Cozart RapiScan opiates and methadone test system is composed of three parts - the oral fluid collection device, the opiates and methadone test cartridge and the Cozart RapiScan instrument.

1. Oral fluid Collection Device: composed of an oral fluid collector pad, a transport tube containing run buffer and a dispense filter tube.
2. Opiate and Methadone Test Cartridge: composed of a white reaction strip with immobilized drug sites for opiates and methadone contained in a blue plastic casing. The cartridge also has a pad containing gold labeled anti-morphine and gold labeled anti-methadone antibodies. In addition, the cartridge has a built in control line of sheep anti-mouse IgG antibody.
3. Cozart RapiScan Instrument: a battery-powered instrument whose function is to automate the analysis of the opiate/methadone test cartridge. It is a hand-held low voltage optical scanner.

Here's an analysis of the Cozart RapiScan Oral Fluid Drug Test System for Opiates and Methadone, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Cozart RapiScan are primarily defined by its ability to accurately detect opiates and methadone in oral fluid at specified cut-off concentrations, as validated against GC/MS. The study demonstrates the device's performance in terms of sensitivity, specificity, precision, and stability under various conditions.

Table of Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Method Comparison Test Set:
     • Total Samples: 454 oral fluid samples.
     • Opiates: 99 RapiScan positive (93 GC/MS confirmed), 124 RapiScan negative (123 GC/MS confirmed). (Total: 223 samples for opiates analysis against GC/MS)
     • Methadone: 116 RapiScan positive (116 GC/MS confirmed), 115 RapiScan negative (115 GC/MS confirmed). (Total: 231 samples for methadone analysis against GC/MS)
     • Special Samples:
       • 24 opiate samples within +/- 50% of cut-off (14 previously diluted with blank saliva).
       • 24 methadone samples within +/- 50% of cut-off (20 previously diluted with blank saliva).
     • Provenance: All samples were oral fluid.
       • 99 opiate-positive samples and 116 methadone-positive samples were from "drug users enrolled at a drug rehabilitation clinic."
       • 103 opiate-negative samples and 102 methadone-negative samples were from "drug free volunteers."
       • 21 opiate-negative samples and 13 methadone-negative samples were from "known drug users."
       • The samples were tested by Cozart Bioscience Ltd staff, and GC/MS performed by FSS Chepstow UK, University of Glasgow, Scotland, and The Analytical Laboratory at Cozart Bioscience Ltd, UK. This suggests a retrospective collection of samples from clinics and volunteers, followed by prospective testing with the RapiScan and GC/MS. The origin is primarily the UK.
   • Precision Test Set (Laboratory): Four oral fluid samples (negative, cutoff, 50% above cutoff, 50% below cutoff) tested in duplicate every day for 20 days (4 samples * 2 duplicates * 20 days = 160 tests per drug).
   • Precision Test Set (Point of Care - POC): Four oral fluid samples (spiked at 0, 6.5, 13, 19.5 ng/mL for opiates and 0, 5, 10, 15 ng/mL for methadone) from drug-free volunteers, tested up to 9 times at 3 POC sites.
   • Sensitivity Test Set: Eight negative oral fluid samples, fortified at 50% above cut-off and serially diluted.
   • Specificity Test Set: Not explicitly stated, but 28 potentially interfering substances and 13 opiate/4 methadone related substances were tested.
   • Cutoff Concentration Test Set: 8 fortified oral fluid samples at various concentrations (cutoff, +/- 50% cutoff, +/- 100% cutoff).
   • Interference Studies Test Set: Not explicitly stated, but various parameters (dye, hemoglobin, common consumables) were tested.
   • Stability Studies Test Set: Four fortified samples (2 at 50% above cutoff, 2 at 50% below cutoff) and two negative samples from volunteers.
   • Time of Day Comparison Test Set: Samples from 4 volunteers at 3 different times of day, fortified.
   • Instrument Comparison Test Set: Samples from 4 volunteers, fortified, tested on 3 different instruments.
   • Operator Comparison Test Set: Samples from 4 volunteers, fortified, tested by "inexperienced operators" (number not specified, but likely at least 3 given the results statement mentions "all three operators").

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The ground truth for the test set (method comparison) was established by Gas Chromatography/Mass Spectrometry (GC/MS). While GC/MS is an analytical method, not human experts, it is considered the "preferred confirmatory method" and gold standard for drug testing. The performing laboratories were FSS Chepstow UK, University of Glasgow, Scotland, and The Analytical Laboratory at Cozart Bioscience Ltd, UK. The qualifications of the GC/MS operators are implied to be standard for analytical laboratory personnel competent in this method.

3. Adjudication method for the test set:

   • Not applicable in the typical sense for medical imaging or clinical decision-making. The "adjudication" here is the direct comparison of the Cozart RapiScan qualitative result (positive/negative) against the quantitative GC/MS result, using the defined cut-off concentrations. Discrepancies would be identified based on whether the RapiScan result matched the GC/MS result relative to the cut-off.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a point-of-care test read by an instrument, not by human readers interpreting complex images or data. The instrument automatically displays results as "positive or negative," eliminating human subjectivity in reading.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance study described is essentially a standalone algorithm performance study. The Cozart RapiScan instrument, which incorporates the device's "algorithm" for reading the test cartridge, operates without human interpretation of the test line. The human interaction involves initiating the test and reading the displayed digital result (positive or negative). The study evaluates the objective output of this system compared to the gold standard. The note that the "Cozart RapiScan instrument must be used to read the cartridges, this eliminates the subjectivity of reading by eye" further supports this being a standalone evaluation of the device's automated reading.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS), which is the "preferred confirmatory method" and considered the analytical gold standard for drug detection and quantification in biological samples.

7. The sample size for the training set:

   • The document does not explicitly state a separate training set size. The studies described are performance validation studies. It's common for such devices (especially those using immunoassay principles rather than complex machine learning algorithms) not to have a distinct "training set" in the sense of AI/ML models. The design and optimization of the immunoassay itself (e.g., antibody selection, cut-off determination) would be based on internal development and verification processes that precede the formal validation studies presented here.

8. How the ground truth for the training set was established:

   • As no explicit training set is mentioned in the context of advanced machine learning, the concept of establishing ground truth for a training set in the typical AI/ML sense is not directly applicable. For the development of the immunoassay, the "ground truth" for calibrating the system and establishing the cut-off concentrations would likely have involved controlled samples with known concentrations of opiates and methadone, confirmed by analytical methods like GC/MS during the R&D phase of the test's design. The "Cutoff Concentration" study described within the document is part of the verification of these established cutoffs.

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