Search Results

The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture.

Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines. cannabinoids, and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multianalyte mixture.

Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture.

This 510(k) premarket notification is for calibrators used with drug abuse assays, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, many of the requested categories (e.g., expert consensus, MRMC studies, standalone performance) are not applicable in the traditional sense for this type of device.

This submission focuses on demonstrating substantial equivalence to already marketed calibrators by Roche. The "acceptance criteria" here are implicitly meeting the performance characteristics and intended use of the legally marketed predicate devices.

Here's an attempt to structure the available information according to your request, with significant caveats for the non-applicability of certain criteria:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A (for traditional diagnostic device testing): This submission is for calibrators, not a diagnostic test that processes patient samples to generate a "test set" in the conventional sense. The "test" here involves comparing the composition and intended use of the new calibrators to existing, cleared predicate calibrators.
• Data Provenance: The calibrators themselves are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This suggests an in-house manufacturing process rather than external data provenance like country of origin or clinical data collection. The submission doesn't specify any external "testing" data from a large population.

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

• Not Applicable: For calibrators, "ground truth" isn't established by expert consensus on clinical images or patient data. The "ground truth" concerning the calibrators' composition is established by the manufacturing process – the quantitative addition of specified drug concentrations to drug-free human urine. Analytical techniques would verify these concentrations during manufacturing and quality control.

4. Adjudication Method for the Test Set

• Not Applicable: There is no clinical "test set" and thus no need for an adjudication method for disagreements among experts, as would be common in diagnostic imaging or clinical assessment studies.

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

• No: MRMC studies are used to assess the impact of a diagnostic device (often AI-based) on human reader performance. This submission is for calibrators, which are reagents used to set the measurement scale for an assay, not a diagnostic tool read by humans.

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

• Not Applicable: Calibrators do not have an "algorithm" or standalone "performance" in the way an AI diagnostic device would. Their function is to provide known reference points for an assay. Their performance is related to their stability, accuracy of stated concentrations, and ability to correctly calibrate the associated assays, which would be validated during manufacturing and quality control, not as a standalone "algorithm."

7. The Type of Ground Truth Used

• Manufacturing Specifications / Quantitative Addition: The "ground truth" for these calibrators is their precisely defined chemical composition. They are "prepared by the quantitative addition of drug or drug metabolite to drug-free human urine." This means the concentration of each drug in each level of the calibrator is precisely known and controlled during the manufacturing process.

8. The Sample Size for the Training Set

• Not Applicable: Calibrators are physical reference materials, not algorithms that require a "training set" of data.

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

• Not Applicable: As above, there is no training set for this type of device.

Ask a specific question about this device

The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT Plus II calibrators contain a mixture of 2 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are benzodiazepines and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture. Drug or drug metabolite and their respective levels included are as follows: Benzodiazepines: 0, 50, 100, 200, 400 ng/ml (no 6th level) Opiates: 0, 150, 300, 600, 1000, 2000 ng/ml. Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 7 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains a single level for each drug mixture. Drugs or drug metabolites and their respective levels included are as follows: Barbiturates: 200 ng/ml Benzodiazepines: 300 ng/ml Cocaine: 150 ng/ml Methadone: 300 ng/ml Opiates: 2000 ng/ml Phencyclidine: 25 ng/ml Propoxyphene: 300 ng/ml

The provided text describes a 510(k) summary for Roche Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators, which are devices used for calibrating drug of abuse assays in human urine on automated clinical chemistry analyzers. As such, the information does not contain acceptance criteria or study results in the typical sense of measuring device performance against a predefined clinical or technical threshold.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device. This regulatory pathway does not require new efficacy studies if the new device is sufficiently similar to a previously cleared one.

Therefore, many of the requested elements for describing acceptance criteria and study results are not applicable to this type of regulatory submission and the provided documentation.

Here's an assessment based on the available information:

1. Table of acceptance criteria and the reported device performance:

• Not applicable. The document does not describe specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its own performance. Instead, it aims to show substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. This document does not describe a performance study with a test set in the way you might expect for a diagnostic device measuring patient outcomes. The "data" here refers to the quantitative addition of drug or drug metabolite to drug-free human urine for calibrator preparation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. Ground truth in this context would relate to the precise concentration of drugs in the calibrators, which is established by the manufacturer through quantitative addition, not by expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No adjudication method is described as this is not a study assessing diagnostic performance against a clinical ground truth.

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:

• Definitely Not applicable. This device is a calibrator for laboratory assays, not an AI-powered diagnostic tool involving human readers.

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

• Not applicable. This is not an algorithm, but a physical calibrator product.

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

• The "ground truth" for the calibrators is the known, quantitatively added concentration of drug or drug metabolite in drug-free human urine. This is an engineered "truth" rather than a discovery-based one (like pathology).

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this device. The calibrators are manufactured to precise specifications.

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

• Not applicable. As above, no training set for this product. The "ground truth" for the calibrators themselves is established by the quantitative addition process during manufacturing.

Summary of what the document DOES provide regarding comparison:

The core of the submission is to establish substantial equivalence to the predicate device: "Abuscreen OnLine Preciset DAT I Calibrators" (K951595).

The comparison focuses on:

• Intended Use: Both the new device and the predicate are designed for the calibration of Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.
• Device Description (Composition):
  • Preciset DAT Plus II: Contains Benzodiazepines (0, 50, 100, 200, 400 ng/ml) and Opiates (0, 150, 300, 600, 1000, 2000 ng/ml). Up to six levels.
  • Cfas DAT Qualitative Plus: Contains Barbiturates (200 ng/ml), Benzodiazepines (300 ng/ml), Cocaine (150 ng/ml), Methadone (300 ng/ml), Opiates (2000 ng/ml), Phencyclidine (25 ng/ml), Propoxyphene (300 ng/ml). Single level.
  • Predicate Device (Abuscreen OnLine Preciset DAT I): Contains a mixture of 9 different drugs (amphetamines, barbiturates, benzodiazepines, cocaine, methadone, methaqualone, opiates, phencyclidine, and propoxyphene). Four levels for each drug.
• All calibrators are prepared by the quantitative addition of drug or drug metabolite to drug-free human urine.

The primary argument for substantial equivalence rests on the similar intended use and the fact that both the new and predicate devices are calibrators for drug of abuse assays, even though the specific drug mixtures and number of levels differ. The regulatory approval letter confirms that the FDA determined the device to be substantially equivalent to legally marketed predicate devices.

Ask a specific question about this device

The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Roche Preciset DAT Plus I calibrators contain a mixture of 9 different drugs, prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and propoxyphene. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture.

This document is a 510(k) Summary for the Roche Preciset DAT Plus I Calibrators. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a medical device's analytical or clinical performance.

Instead, this submission is for calibrators, which are used to standardize other assays. The "performance" in this context refers to their composition and their equivalence to a legally marketed predicate calibrator.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes for test/training, number of experts, adjudication, MRMC studies, standalone studies, ground truth types) are not applicable or not reported in this type of submission for a calibrator device.

Here's a breakdown of the information that can be extracted, and where the requested information is absent:

1. A table of acceptance criteria and the reported device performance:

This document does not explicitly state acceptance criteria or report performance data for the calibrators in terms of accuracy, precision, or other analytical metrics. The claim of performance is based on the contents and the comparison to an existing predicate calibrator.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This document describes the calibrator itself, not a study evaluating its performance with test samples. The "test set" in this context would implicitly be the various drug assays that would be calibrated using this device, which are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This device is a calibrator, and its "ground truth" is its precisely defined chemical composition. There are no human experts involved in establishing this type of ground truth for a calibrator.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set or adjudication process is described.

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 a calibrator, not an AI-powered diagnostic tool, and involves no human readers or AI assistance.

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

Not applicable. This device is a calibrator and does not involve an algorithm.

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

The "ground truth" for these calibrators is their known, quantitative chemical composition. They are prepared by the "quantitative addition of drug or drug metabolite to drug-free human urine" {1}.

8. The sample size for the training set:

Not applicable. This document describes a calibrator, not a machine learning model that would require a training set.

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

Not applicable. No training set is involved.

Ask a specific question about this device

The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Quantimetrix Preciset® DAT Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids. Drug concentrations are determined using GC/MS.

This document describes the Preciset® DAT Plus, a drug of abuse calibrator. It does not contain information about a device that uses AI or machine learning, nor does it detail a study with acceptance criteria and device performance in the context of such technology. Therefore, I cannot generate the requested table and study information.

The document primarily focuses on the 510(k) submission for the Preciset® DAT Plus calibrators, detailing its classification, intended use, and substantial equivalence to a predicate device. It briefly mentions "Performance Characteristics" related to stability studies but does not provide specific acceptance criteria or quantitative performance data.

Ask a specific question about this device