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Verdict®-II THC/COC/OPI/MAMP-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine (MAMP), and 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations:
Cannabinoids (11 nor-9-carboxy-Δ 9 -THC)-50 ng/ml
Opiates (morphine)-300 ng/ml
Cocaine (benzoylecgonine)-300 ng/mL
Methamphetamine (MAMP)-1000 ng/mL
3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL
This product is not for over-the-counter-sale
Verdict®-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result

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This is an FDA 510(k) clearance letter for the Verdict®-II THC/OPI/COC/MAMP-MDMA, a rapid, qualitative immunochromatographic test for the detection of various drugs and their metabolites. The provided document details the indications for use but does not contain the specific study data, acceptance criteria, or performance metrics typically requested for a device.

Therefore, many of the requested items cannot be extracted directly from this document.

However, I can extract the indication for use and the cut-off concentrations, which are fundamental to understanding the device's intended performance.

Acceptance Criteria and Reported Device Performance (Based on provided information):

The document defines the cut-off concentrations for detecting the major metabolites of the specified drugs. While it doesn't explicitly state "acceptance criteria" in a table format, these cut-off levels inherently define the performance target for the device's qualitative detection. It does not provide data on the device's actual performance against these cut-offs (e.g., sensitivity, specificity, accuracy).

Since the provided document is a 510(k) clearance letter, it primarily states that the device is substantially equivalent to a predicate device and provides its intended use and general characteristics. It does not include the detailed study report that would contain the specific information requested for points 2 through 9.

Therefore, for the following points, the answer is "Not provided in the document."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
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 for this type of diagnostic test (which is not an AI-assisted imaging device). Not provided in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an immunochromatographic test, not an algorithm. Its performance is inherent to the chemical reaction. Not provided in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. For drug tests, ground truth typically involves a confirmatory method like GC/MS. The document specifies GC/MS as the preferred confirmatory method but doesn't detail how it was used in a study.
8. The sample size for the training set: Not applicable (not an AI device). Not provided in the document.
9. How the ground truth for the training set was established: Not applicable (not an AI device). Not provided in the document.

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Verdict®-II Propoxyphene/Methamphetamine-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of methamphetamine (MAMP), 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites; propoxyphene, and its main metabolite norpropoxyphene. The test detects the major metabolites of these drugs at the following cutoff concentrations:
Methamphetamine (MAMP)-1000 ng/mL
3,4-methylenedioxymethlyamphetamine (MDMA)-1500 ng/mL
Norpropoxyphene (Main metabolite of propoxyphene)-300 ng/mL
This product is not for over-the-counter-sale
Verdict®-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result

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The provided text is a 510(k) premarket notification letter from the FDA for a device called "Verdict®-II Propoxyphene/Methamphetamine-MDMA." This document does not contain a detailed study report with the specific acceptance criteria and performance data requested. It primarily focuses on the regulatory approval process and the intended use of the device.

Therefore, I cannot provide the requested information based on the given input, as the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Information about experts, adjudication methods, MRMC studies, or standalone algorithm performance.
• Details on how ground truth was established for training or test sets, or the sample size for the training set.

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VERDICT® II PROPOXYPHENE is a one-step immunochromatographic test for the rapid, qualitative detection of propoxyphene and its metabolite, norpropoxyphene, in human urine. The test detects the major urinary metabolite of propoxyphene (norpropoxyphene) at 300 ng/mL. It is not for over-the-counter sale. VERDICT®-II PROPOXYPHENE PROVIDES ONLY A PRELIMINARY ANALYTICAL TEST RESULT. A MORE SPECIFIC ALTERNATE CHEMICAL METHOD MUST BE USED IN ORDER TO OBTAIN A CONFIRMED ANALYTICAL RESULT. GAS CHROMATOGRAPHY/ MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. CLINICAL CONSIDERATION AND PROFESSIONAL JUDGMENT SHOULD BE APPLIED TO ANY DRUG OF ABUSE TEST RESULT, PARTICULARLY WHEN PRELIMINARY POSITIVE RESULTS ARE OBTAINED.

VERDICT®-II PROPOXYPHENE is a one-step immunochromatographic test.

1. Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The adjudication method is not mentioned in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size of human reader improvement with AI assistance, is provided in the document. This is an in vitro diagnostic device, and such studies are typically not performed for this type of product.

6. Standalone Performance (Algorithm Only)

The device, VERDICT®-II PROPOXYPHENE, is described as a "one-step immunochromatographic test." This indicates it's a physical test kit, not an algorithm, and therefore the concept of standalone (algorithm-only) performance does not apply. The document does state that the test provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result" (e.g., GC/MS). This implies the device's performance is as a screening tool, not a definitive standalone diagnostic.

7. Type of Ground Truth Used

The document explicitly states that the device provides "only a preliminary analytical test result" and that "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GAS CHROMATOGRAPHY/ MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD." This indicates that the ground truth for validating the device's performance would be established by a "gold standard" confirmatory method like GC/MS.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document focuses on the device's indications for use and substantial equivalence to a predicate device. It does not detail the specific methodology for establishing ground truth for any training set. However, given the nature of the device (a rapid screening test for drug detection) and the mention of GC/MS as a confirmatory method, it's highly probable that samples with known concentrations of propoxyphene and norpropoxyphene (likely confirmed by methods like GC/MS) would be used to develop and validate such a test.

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VERDICT -II OPIATES 2000 is a one-step immunochromatographic test for the rapid, qualitative detection of opiates (morphine and/or codeine) in human urine. The test detects opiates and their major metabolites at the cut-off concentration of 2000ng/mL. It is not for overthe-counter sale.

VERDICT®-II OPIATES 2000 provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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Here's an analysis of the provided FDA document regarding the VERDICT®-II OPIATES 2000 device, focusing on acceptance criteria and study details:

This document, an FDA 510(k) clearance letter, primarily establishes that the VERDICT®-II OPIATES 2000 device is substantially equivalent to a legally marketed predicate device. It does not contain detailed information about specific acceptance criteria or a comprehensive study report designed to prove the device meets those criteria with a specified performance metric.

The document does describe the device's intended use and the concentration it detects, which implicitly sets a functional performance expectation.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not explicitly state "acceptance criteria" in terms of sensitivity, specificity, accuracy percentages, or other statistical measures. Instead, it defines the functional capability of the 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 available. The 510(k) clearance letter does not describe the specific study data (sample size, provenance) used by the manufacturer to demonstrate substantial equivalence. This information would typically be in the full 510(k) submission, not in the FDA's clearance letter.

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 available. The document does not provide details about clinical studies, expert involvement, or the qualifications of such experts.

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

Not applicable/Not available. Since it's an in-vitro diagnostic test for drug detection and not an image-based diagnostic, adjudication methods like N+1 are not typically used in the same way. The document does not describe any specific adjudication process.

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 immunochromatographic test, not an AI-assisted diagnostic device that would involve human readers interpreting AI output. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Yes, implicitly. The VERDICT®-II OPIATES 2000 is an in-vitro diagnostic test. Its performance is evaluated as a standalone product. While the result is "preliminary" and requires confirmation, the device itself operates without continuous human intervention during the test run. The "standalone" performance would be its accuracy, sensitivity, and specificity in detecting opiates at the specified cut-off, although these metrics are not provided in this document.

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

The document states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."

This strongly implies that GC/MS is the gold standard (ground truth) for confirming the presence and concentration of opiates.

8. The sample size for the training set

Not available. This device is not an AI/machine learning product that undergoes "training." Its performance is based on the inherent chemical and immunological properties of its components.

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

Not applicable. See point 8.

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