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Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. Barbiturates Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Secobarbital drug derivative is conjugated to microparticles in solution, and secobarbital polyclonal antibody (sheep) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug-microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. 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 a medical device called "ONLINE DAT Barbiturates Plus." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with acceptance criteria, sample sizes, and expert reviews in the way typically seen for new diagnostic algorithms or AI-driven devices.

Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, training set details) are not applicable or not mentioned in this type of submission. This document describes an in vitro diagnostic assay, which typically relies on analytical performance studies (accuracy, precision, linearity, etc.) rather than clinical read studies with human experts.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding "reported device performance" in the context of clinical accuracy when read by humans, as this is an in vitro diagnostic test rather than an image-based AI or diagnostic decision support tool.

However, the core performance relates to its ability to detect barbiturates at a specific cutoff. The predicate device's performance, which is implicitly the benchmark for "acceptance criteria" for substantial equivalence, is:

• Cutoff: 200 ng/ml for qualitative and semi-quantitative detection of barbiturates in human urine.

The new device, ONLINE DAT Barbiturates Plus, also states its performance characteristic:

• "The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml."

Since the purpose of the 510(k) is to demonstrate substantial equivalence, the "acceptance criteria" are implied to be that the new device performs comparably to the predicate device, especially regarding its detection characteristics like the cutoff level. No specific sensitivity/specificity values are given for clinical performance, as this is a chemical assay.

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

The document does not specify a "test set" in the context of clinical samples or a human-read study. For an in vitro diagnostic assay, sample sizes would typically refer to the number of spiked samples, patient samples, or controls used in analytical studies (e.g., accuracy, precision, linearity, interference). This information is not provided in the summary.

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

Not Applicable. This is an in vitro diagnostic assay. Ground truth for such assays is typically established through reference chemical methods (e.g., GC/MS) or by spiking known concentrations of the analyte into samples, not via expert consensus on clinical interpretation.

4. Adjudication method for the test set

Not Applicable. See point 3.

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 is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or decision support device.

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

The device is an in vitro diagnostic assay designed to be run on automated clinical chemistry analyzers. Its performance is inherently "standalone" in the sense that the assay itself generates the result without human interpretive input beyond following laboratory procedures. The output is a preliminary analytical test result.

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

While not explicitly stated for this specific submission, for in vitro diagnostic assays like this, the "ground truth" for performance evaluation typically involves:

• Reference Chemical Methods: Such as Gas Chromatography-Mass Spectrometry (GC/MS) which is considered the gold standard for drug quantification.
• Known Concentrations: Samples spiked with precise, known quantities of barbiturates.

The 510(k) summary only mentions that "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result," implying that the assay provides preliminary results, and a confirmatory method establishing "ground truth" would be separate.

8. The sample size for the training set

Not Applicable. This is an in vitro diagnostic assay, not a machine learning model that requires a "training set" in the typical sense of AI/ML. The assay formulation is developed through biochemical research and optimization, not data-driven model training.

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

Not Applicable. See point 8.

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