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The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers.

The Roche Diagnostics Acetaminophen assays under consideration in this submission are the same assays as were cleared on the COBAS Integra in K991598, Hitachi 917 in K013757 and cobas c501 in K060373 for the quantitative determination of toxic levels of Acetaminophen in human serum and plasma on automated clinical chemistry analyzers. The same reagents are used on all three systems. Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol and acetate. Subsequently, the p-aminophenol is converted to an indophenol in the presence of o-cresol and a periodate catalyst. The production of indophenol is followed colorimetrically. The change in absorbance is directly proportional to the quantitative drug concentration in the sample.

The acceptance criteria for the Roche Acetaminophen assay are based on demonstrating substantial equivalence to previously cleared predicate devices: Roche COBAS Integra Acetaminophen assay (K991598), Roche/Hitachi Acetaminophen assay (K013757), and cobas c501 Acetaminophen assay (K060373). The study performed by Roche Diagnostics focused on validating the performance of the new Roche Acetaminophen assays on the cobas 8000 Modular Analyzer Series, specifically on the cobas c501 and Hitachi 917 platforms, and confirming similar performance on the COBAS Integra platform.

The study did not explicitly state "acceptance criteria" in terms of numerical thresholds for performance metrics. Instead, it demonstrated equivalence by comparing the analytical characteristics of the new assays with those of the predicate devices. The key performance aspects compared include:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

Important Note on Measuring Range and Sensitivity: While the new device's LoB is 1.2 µg/ml for all platforms, the "Measuring range" starts at 15 µg/ml. This is a key difference from the predicate devices which had measuring ranges starting at their respective LDLs (1.2 µg/ml or 0.7 µg/ml). The LoQ (Limit of Quantitation) of 15 µg/ml seems to define the lower end of the measuring range for the new device. Additionally, the new assays performed more extensive bilirubin interference testing (at 15, 30, and 50 µg/ml) compared to the predicates (only at 50 µg/ml).

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

• The document does not explicitly state the sample sizes used for the analytical performance studies (e.g., for LoB, LoD, LoQ, measuring range, specificity, or interference testing).
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

• This information is not applicable to this type of submission. This is a 510(k) for an in vitro diagnostic (IVD) assay based on chemical/enzymatic reactions. The "ground truth" for an IVD assay's analytical performance (e.g., concentration of acetaminophen) is established through reference methods, certified reference materials, and robust analytical chemistry techniques, not through expert consensus on images or clinical outcomes.

4. Adjudication method for the test set:

• This information is not applicable as it pertains to expert reviews of data, which is not how analytical performance of IVD assays is typically established.

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 is an IVD device, not an AI-powered diagnostic system that assists human readers.

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

• Yes, the performance described is the standalone performance of the analytical assay (the "algorithm" here is the chemical reaction and measurement system). There is no "human-in-the-loop" performance being evaluated in the context of this device's function.

7. The type of ground truth used:

• The "ground truth" for the analytical performance of this assay would be established using reference methods (e.g., gas chromatography-mass spectrometry (GC-MS) or high-performance liquid chromatography (HPLC) for acetaminophen quantification) and certified reference materials with known concentrations of acetaminophen. The document doesn't explicitly detail the reference methods used but implies the use of quantitative standards for calibration and evaluation.

8. The sample size for the training set:

• This information is not explicitly stated as it's an analytical assay and not a machine learning algorithm that typically requires a distinct "training set." The development of such assays involves extensive R&D, method optimization, and analytical validation which uses various samples and experiments, but these are not typically referred to as a "training set" in the context of AI/ML.

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

• As above, the concept of a "training set" with established ground truth in the AI/ML sense is not applicable here. The analytical accuracy and precision are established through internal validation studies using known concentrations of analytes and comparison to reference methods, not through human-adjudicated ground truth.

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For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acctaminophen overdose.

The Roche Acetaminophen assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche Acetaminophen reagent kits.

Here's an analysis of the provided text regarding the Roche Acetaminophen Assay, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the Roche Acetaminophen Assay. However, it does present performance characteristics for comparison to the predicate device. For the purpose of this response, I will infer the acceptance criteria are implicitly defined by the acceptable performance compared to the predicate and the general requirements for such assays (e.g., adequate precision and method correlation).

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

• Test Set Sample Size:
  • For comparison against the Roche COBAS INTEGRA Acetaminophen assay on the COBAS Integra 700: N = 150
  • For comparison of the predicate device (Roche COBAS INTEGRA Acetaminophen) against the Abbott TDx Acetaminophen assay: N = 87 (This refers to data for the predicate, not the new device's primary test set)
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

This information is not applicable to this type of device. The Roche Acetaminophen Assay is an in vitro diagnostic (IVD) quantitative assay. Its "truth" is established by comparing its measurements to a reference method (the predicate device) or a gold standard method, not by expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or subjective assessment involved that would require adjudication for this IVD assay. The comparison is based on quantitative analytical results.

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

This is not applicable. The Roche Acetaminophen Assay is an IVD device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or classification tool that would involve human "readers."

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

The performance of the Roche Acetaminophen Assay, as described, is inherently a "standalone" performance in the context of an IVD. It generates a quantitative result without human intervention in the analytical process. The study described (method comparison) assesses this standalone analytical performance against a known method.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by comparing the results of the new Roche Acetaminophen Assay against a predicate device (Roche COBAS INTEGRA Acetaminophen Assay), which is itself an already validated and legally marketed device. In essence, the predicate serves as the reference method or "gold standard" for this comparative study.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a "training set" in the context of this chemical assay. Chemical assays are developed and validated through analytical studies, not typically machine learning training protocols.

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

This is not applicable as there is no training set described for this type of device.

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