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The Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin reagent is intended for use for the quantitative determination of direct bilirubin in serum and plasma of adults and neonates. It is for use on automated clinical chemistry analyzers.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1110, a bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Direct bilirubin, in the absence of a suitable solubilizing agent, is coupled with a diazonium ion in a strongly acid medium (pH 1 - 2).

Bilirubin + diazonium ion acid -> Azobilirubin

The intensity of the color of the azobilirubin formed is proportional to the direct bilirubin concentration and can be measured photometrically.

The provided 510(k) summary for the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent does not explicitly state acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer the strategy for demonstrating equivalence and what would constitute "acceptance" in this context. The core of the submission is showing that the new device performs similarly to the predicate device, especially for its intended use.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission implicitly states that the acceptance criterion is "substantial equivalence" to the predicate device, particularly regarding performance characteristics. While no numerical acceptance targets are listed, the document implies that the new device's performance is acceptable if it is comparable to the predicate.

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

This information is not provided in the given 510(k) summary. The summary refers to "Specific data on the performance of the system have been incorporated into the draft labeling in Section V of this submission." This section would contain details about the actual study: sample sizes (e.g., number of patient samples tested), and likely whether it was retrospective or prospective, and general location of data collection (e.g., in-house lab, clinical sites).

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

This is not applicable in the context of this in vitro diagnostic (IVD) device. For IVD reagents like the direct bilirubin test, the "ground truth" is typically established by comparing results to a recognized reference method or another already validated, legally marketed device (the predicate). There wouldn't be "experts" establishing ground truth in the way a radiologist reads images.

4. Adjudication Method for the Test Set

This is not applicable for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials, especially for imaging devices, where human readers consensus is required for ground truth. For an IVD, the comparison is typically against quantitative analytical results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (Human Improvement with AI vs. Without AI)

This is not applicable. This submission is for an in vitro diagnostic reagent, not an AI-powered device or an imaging device that involves human readers interpreting results.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as it's an IVD reagent, not an AI algorithm. The device itself is the "standalone" entity that produces a quantitative result.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be established by:

• Comparison to a legally marketed predicate device: The submission explicitly states "substantially equivalent to the currently marketed Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system". Performance studies would involve running patient samples on both the new device and the predicate device and showing acceptable correlation and agreement.
• Reference Methods: In some cases, established reference methods for bilirubin measurement might be used, but the primary method for demonstrating equivalence in a 510(k) is usually comparison to the predicate.

8. The Sample Size for the Training Set

This is not applicable in the context of this device. "Training set" refers to data used to train machine learning models. This is a chemical reagent, not an AI algorithm.

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

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

Summary of the Study (Inferred from the Document):

The study performed to demonstrate substantial equivalence for the Roche Diagnostics, Boehringer Mannheim Liquid Direct Bilirubin Reagent would have involved running a series of patient samples on both the new liquid reagent system and the predicate solid reagent system (Roche Diagnostics, Boehringer Mannheim Direct Bilirubin reagent system, catalog number 704027). The "acceptance criteria" were implicitly that the performance (e.g., accuracy, precision, linearity, interference) of the new reagent was comparable to, or within acceptable limits of variation from, the predicate device.

The specific data details (sample size, statistical analysis, actual performance numbers) are referenced as being in "Section V of this submission" and are not included in the provided 510(k) summary excerpt. The focus of the provided text is on outlining the similarities and minor differences (like reagent stability and preparation) between the new and predicate devices, and asserting that the performance characteristics are substantially equivalent.

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