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The cassette COBAS INTEGRA Serum Barbiturates contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.

The Abuscreen ONLINE Serum Barbiturates Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Barbiturates on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of barbiturates in human specimens.

The cassette COBAS INTEGRA Serum Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of benzodiazepines and their metabolites in human serum or heparinized plasma. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.

The Abuscreen ONLINE Serum Benzodiazepines Calibrators are designed for calibration of the cassette COBAS INTEGRA Serum Benzodiazepines on the COBAS INTEGRA chemistry systems. The calibrators are used in the determination of values in the measurement of benzodiazepines in human specimens.

The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer, which is also known as the COBAS INTEGRA 700. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents. Through this submission, it is the intention of Roche to gain clearance for two additional COBAS Reagent Cassettes and their associated calibrator sets. These are: the COBAS INTEGRA Serum Barbiturates (SBARB) Reagent Cassette, the Abuscreen ONLINE Serum Barbiturates Calibrators, the COBAS INTEGRA Serum Benzodiazepines (SBENZ) Reagent Cassette, and the Abuscreen ONLINE Serum Benzodiazepines Calibrators.

Here's an analysis of the acceptance criteria and study information for the Roche COBAS® INTEGRA Reagent Cassettes and Calibrators, based on the provided text:

Important Note: The provided document is a 510(k) Summary for a medical device cleared in 1998. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through a standalone, comprehensive clinical trial with pre-defined acceptance criteria in the way a new, high-risk device might today. The "acceptance criteria" detailed below are derived from the performance characteristics presented for comparison with the predicate device. The study is primarily a comparative effectiveness study against the predicate, alongside internal analytical validation.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a pass/fail format with specific targets that the device must meet in a prospective study. Instead, it presents performance characteristics of the new device alongside those of its predicate for comparison, implying that the new device's performance should be comparable or substantially equivalent to the predicate. The "reported device performance" refers to the values presented for the COBAS INTEGRA system.

A. COBAS INTEGRA Serum Barbiturates (SBARB)

B. COBAS INTEGRA Serum Benzodiazepines (SBENZ)

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

• COBAS INTEGRA Serum Barbiturates (SBARB):

  • Accuracy (compared to GC/MS): 47 samples (37 positive, 10 negative)
  • Accuracy (compared to Predicate ADX): 47 samples (35 positive, 12 negative)
  • Precision: Not explicitly stated, but typically involves multiple replicates across several runs for each level tested. Given the three levels and %CV calculation, a common practice would be 20 replicates for 2-3 levels over 2-3 days, resulting in at least 40-60 measurements per level. The exact number of individual patient samples used to derive these mean and CV values is not specified, but these are typically control or spiked samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective analytical performance evaluations conducted by the manufacturer as part of the submission to demonstrate equivalence.

• COBAS INTEGRA Serum Benzodiazepines (SBENZ):

  • Accuracy (compared to GC/MS): 74 samples (46 positive, 28 negative)
  • Accuracy (compared to Predicate TDX): 66 samples (46 positive, 20 negative)
  • Precision: Similar to SBARB, not explicitly stated, but common practice would imply multiple replicates for each of the three levels tested.
  • Data Provenance: Not explicitly stated. Likely retrospective analytical performance evaluation.

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

• For both assays (Barbiturates and Benzodiazepines), the ground truth for accuracy was established using GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is considered a "gold standard" analytical method for drug confirmation and quantification in toxicology.
• The document does not specify the number of human experts involved in interpreting the GC/MS results or their qualifications. The interpretation of GC/MS data is typically performed by trained laboratory personnel (e.g., analytical chemists, toxicologists) within a certified laboratory environment.

4. Adjudication Method for the Test Set

• For the accuracy studies using GC/MS as the ground truth, there is no mention of an adjudication method in the traditional sense (e.g., 2+1 physician review). The GC/MS result itself serves as the definitive determination. Discrepancies between the device and GC/MS would be investigated analytically rather than through expert consensus on the clinical classification.

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

• No, an MRMC comparative effectiveness study was not done. This submission concerns in vitro diagnostic (IVD) reagent assays, which are standalone laboratory tests, not imaging devices or AI-assisted diagnostic tools that involve human readers. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

• Yes, this entire submission effectively represents a standalone performance evaluation. The COBAS INTEGRA system, with these reagent cassettes, performs automated analysis. Its performance characteristics (precision, accuracy, sensitivity, assay range, cutoff) are measured directly based on the analytical results produced by the instrument and reagents, without immediate human intervention in the result generation itself. Human interaction would occur in sample loading, result review, and clinical interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth for the accuracy claims was:
  • GC/MS (Gas Chromatography/Mass Spectrometry): This is a highly specific and sensitive analytical method for confirming and quantifying drugs, serving as the gold standard in toxicology for this type of test.

8. The Sample Size for the Training Set

• The document does not specify the sample size for a training set. For IVD assays based on established chemical principles (like fluorescence polarization immunoassay), there isn't a "training set" in the same way there would be for a machine learning or AI algorithm. The assay's parameters (e.g., antibody concentrations, reaction times, calibration curves) are developed and optimized by the manufacturer using internal R&D processes, but these are not explicitly detailed as a "training set" in the context of this 510(k) summary. The performance data presented are for the final, developed product.

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

• As a "training set" is not explicitly mentioned or applicable in the AI/machine learning sense for this device, the question of how its ground truth was established is not directly answerable from the provided text. The development and optimization of such assays rely on well-characterized samples (e.g., spiked samples, confirmed positive/negative clinical samples, reference materials) to establish robust analytical performance, but these are part of the R&D process rather than a formalized "training set" with ground truth in the context of this regulatory submission.

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