Search Results

Cocaine II is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The ONLINE DAT II Cocaine II assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission.

The provided text is a 510(k) Summary for the Roche Diagnostics ONLINE DAT II Cocaine II assay. This document describes an in vitro diagnostic test and establishes its substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be presented to prove a device meets specific acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided text, nor can I provide details on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is missing from the 510(k) summary.

Here's what I can extract based on the available information, along with what is explicitly missing:

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

• Missing. The 510(k) summary does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or a performance table. It describes the device and its intended use, then compares it generally to a predicate device, but does not present the results of a validation study against predefined criteria.

2. Sample size used for the test set and the data provenance:

• Missing. The document does not mention any specific test set, sample sizes, or data provenance (country of origin, retrospective/prospective nature).

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

• Missing. Since no specific test set or study results are detailed, there is no information on expert involvement for ground truth establishment.

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

• Missing. Adjudication methods are not discussed as no test set details are provided.

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 / Missing. The device described is an in vitro diagnostic assay (a chemical test), not an AI-assisted diagnostic tool that would involve human "readers" or an MRMC study in the typical sense of imaging or clinical interpretation.

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

• Yes, implicitly. This is a standalone in vitro diagnostic assay. Its performance would be evaluated as "algorithm only" (i.e., the assay's chemical reaction and detection system) without human intervention in the result generation itself (though human intervention is required for sample collection and operating the analyzer). However, the specific performance metrics and studies are not detailed here.

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

• Likely reference methodology or spiked samples, but not explicitly stated. For an immunoassay detecting a specific metabolite, ground truth would typically be established using:
  • Confirmatory quantitative methods (e.g., GC/MS or LC/MS) on urine samples.
  • Urine samples spiked with known concentrations of the analyte.
• The document does not state how ground truth was established for any performance evaluation.

8. The sample size for the training set:

• Not applicable / Missing. For an immunoassay, there isn't a "training set" in the machine learning sense. The assay's "training" refers to its development and optimization based on chemical principles, antibody-antigen binding, and reaction kinetics. However, data would be collected during development to optimize parameters and establish cutoff values. This specific sample size is not mentioned.

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

• Not applicable / Missing. (See point 8).

Summary of what is available:

• Device Name: ONLINE DAT II Cocaine II
• Intended Use: Qualitative and semi-quantitative detection of benzoylecgonine (cocaine metabolite) in human urine on automated clinical chemistry analyzers at cutoff concentrations of 150 and 300 ng/ml. Also permits assessment of assay performance as part of a quality control program.
• Predicate Device: Abuscreen OnLine Cocaine Metabolite assay (K983697)
• Principle of Procedure: Kinetic Interaction of Microparticles in a Solution (KIMS) – an immunoassay where drug-polymer conjugates bind to antibody-bound microparticles, causing aggregation. In the presence of sample drug, this aggregation is inhibited. Absorbance changes are measured.
• Key Differences from Predicate:
  • Use of a benzoylecgonine monoclonal antibody (mouse) attached to microparticles.
  • A soluble drug-polymer conjugate.
  • Addition of a 150 ng/ml cutoff concentration.
  • Use of new calibrators and unassayed controls.

To obtain the detailed study information, acceptance criteria, and performance data, one would typically need to refer to the full 510(k) submission or an associated scientific publication or device manual, which are not included in the provided text.

Ask a specific question about this device

The cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

The cassette COBAS INTEGRA Cocaine II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine at cutoff concentrations of 150 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The COBAS INTEGRA ONLINE DAT II Cocaine II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drugpolymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. When a urine sample containing the drug in question is present, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody . Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

The provided text is a 510(k) summary for the Roche COBAS INTEGRA ONLINE DAT II Cocaine II assay. It details the device, its intended use, and its comparison to a predicate device. However, it does not include any section describing acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided document.

To answer your request, I would need a section from the 510(k) submission that details:

• Performance characteristics studies (e.g., accuracy, precision, sensitivity, specificity, interference)
• The acceptance criteria set for these performance characteristics
• The results of the studies showing how the device met those criteria.

Without this information, I cannot complete the table or answer the specific questions about sample size, ground truth, expert involvement, or comparative effectiveness studies.

Ask a specific question about this device