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510(k) Data Aggregation
(38 days)
The Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin reagent is intended for use for the quantitative determination of total 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 distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
Total bilirubin, in the presence 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 total bilirubin concentration and can be measured photometrically.
The provided document describes a 510(k) premarket notification for the "Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent." This is an in vitro diagnostic device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel AI algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML devices do not directly apply.
However, I can extract the relevant performance characteristics and details provided for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic such as a reagent, "acceptance criteria" are typically related to analytical performance characteristics like accuracy, precision, linearity, and correlation with a predicate device. The document primarily focuses on demonstrating that the new liquid reagent performs similarly to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (New Liquid Total Bilirubin Reagent) |
|---|---|---|
| Intended Use | To measure total bilirubin in serum and plasma. | Measurement of total bilirubin in serum and plasma of adults and neonates. For use on automated clinical chemistry analyzers. |
| Sample Type | Serum or plasma, no preparation required. | Serum or plasma, no preparation required. |
| Use on Automated Analyzers | Yes | Yes |
| Test Principle | Diazo reaction with azobilirubin product, measured spectrophotometrically. | Diazo reaction with formation of an azobilirubin product, measured spectrophotometrically. (Bilirubin + diazonium ion (acid) -> Azobilirubin. Intensity of color is proportional to total bilirubin concentration). |
| Calibration | Two points, blank (saline) and about 2.6 mg/dL total bilirubin. | Two points, blank (saline) and about 2.6 mg/dL total bilirubin. |
| Calibration Stability | Perform new calibration once a week, or with bottle/reagent lot change. | Perform a new calibration once a week, or with a bottle or reagent lot change. |
| Reagent On-board Stability | 5 days (predicate) | 5 weeks (Significant improvement over predicate) |
| Kit Configuration, Reagent Preparation | R1a, lyophilized, requires reconstitution with buffer; R1, buffer. | R1, liquid, ready-to-use; R2, liquid, ready-to-use. (Significant improvement in ease of use/preparation). |
| Overall Performance | Substantially equivalent to predicate for similar use. | Stated as "substantially equivalent to other products in commercial distribution intended for similar use," specifically the currently marketed Roche Diagnostics, Boehringer Mannheim Total Bilirubin/DPD reagent system, catalog number 1039034 (K781921). Specific quantitative performance data (e.g., accuracy, precision studies) are not provided in this summary but are referenced as being "incorporated into the draft labeling in Section V of this submission." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) Summary document does not explicitly state the sample size used for performance testing (e.g., patient samples for method comparison or clinical studies) nor the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Specific data on the performance of the system [that have] been incorporated into the draft labeling in Section V of this submission," which is not included in the provided text.
For this type of IVD, performance data would typically involve:
- Method comparison studies: Comparing results from the new device to the predicate device using a range of patient samples.
- Precision studies: Assessing within-run, between-run, and total precision.
- Linearity studies: Verifying the analytical measurement range.
- Interference studies: Testing for substances that might affect results.
Without the "Section V" labeling, these specific details are unavailable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a diagnostic reagent, not an AI/ML algorithm. Therefore, "ground truth" for the test set is established through analytical methods and comparison to a legally marketed predicate device (and often to reference methods if available), not by human expert opinion or consensus in the context of imaging or clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable in the context of an IVD reagent's analytical performance.
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 IVD reagent, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an IVD reagent, which inherently operates "standalone" in the sense that it measures a specific analyte. Its performance is evaluated against analytical standards and predicate devices, not as an "algorithm only" in the AI sense.
7. The Type of Ground Truth Used
For this IVD reagent, the "ground truth" for its performance evaluation would primarily be:
- Results from the legally marketed predicate device: The new device's measurements are compared to those obtained from the predicate to demonstrate substantial equivalence.
- Reference methods (if applicable and used in internal studies): Highly accurate, often more complex, methods used to determine true analyte concentrations.
- Known concentrations in control materials: Used for precision, linearity, and calibration verification.
8. The Sample Size for the Training Set
Not applicable in the context of a chemical reagent and its analytical evaluation. This is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for an AI/ML algorithm in this submission.
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