(23 days)
C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels.
The provided text is a 510(k) summary for a medical device called "C.f.a.s. (Calibrator for Automated Systems) HbA1c". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data as often seen for diagnostic or therapeutic devices.
Therefore, many of the requested elements for a study proving device performance are not directly available in the provided text. The summary emphasizes the similarities and differences between the new calibrator and its predicate, asserting that these differences do not raise new questions of safety or effectiveness.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the document as it would be for a typical performance study. For a calibrator, "performance" is typically related to its stability, accuracy in providing a known concentration, and its ability to enable accurate measurements by the instrument it calibrates. The document asserts that the new device is substantially equivalent to a predicate calibrator.
| Characteristic | Predicate Calibrator (Performance/Reference) | C.f.a.s. HbA1c (Claimed Performance/Features) | Acceptance Criteria (Implied) |
|---|---|---|---|
| Intended Use | Calibration of quantitative Tina-Quant HbA1c method | Calibration of quantitative Roche methods on Roche clinical chemistry analyzers | To perform its intended calibration function effectively |
| Format | Lyophilized | Same | Maintain physical form and usability |
| Matrix & Composition | Hemolysate from human and sheep blood; 0.9% TTAB; stabilizers | Same | Maintain chemical stability and compatibility |
| Handling (Reconstitution) | 1.0 mL distilled or deionized water | 2.0 mL distilled or deionized water | Reconstitution leads to a stable and correct concentration |
| Levels | Four levels | Single level (diluted on-board to 6 levels) | Enable generation of accurate calibration curve when diluted |
| Stability (Unopened) | Up to expiration date | Same | Maintain integrity and performance until expiration |
| Stability (Reconstituted, 2-8°C) | 2 days | 2 days | Maintain integrity and performance for specified duration |
| Stability (Reconstituted, 20-25°C) | 8 hours | 8 hours (15-25°C) | Maintain integrity and performance for specified duration |
| Stability (Reconstituted, -20°C) | 3 months | 3 months (-15 to -25°C) | Maintain integrity and performance for specified duration |
The "acceptance criteria" for a calibrator like this would typically involve:
- Assigned value accuracy: The calibrator, once reconstituted, must have an accurate and stable assigned value for HbA1c.
- Stability: Meeting the stated stability claims (unopened, reconstituted at different temperatures and durations).
- Method compatibility: Successfully calibrating Roche clinical chemistry analyzers for Roche HbA1c methods, leading to accurate patient sample results.
The document implies these criteria are met by stating substantial equivalence to a predicate device with identical core characteristics. No quantitative performance metrics are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. As a 510(k) summary for a calibrator, it focuses on the device's characteristics and its equivalence to a predicate, not on a clinical trial with a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable/not provided. The device is a calibrator, not a diagnostic tool that interprets patient data. Therefore, there's no "ground truth" for a test set of patient cases established by experts in this context. The "ground truth" for a calibrator would be its accurately assigned HbA1c concentration.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. There is no "test set" of patient data that would require expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable/not provided. This type of study is relevant for diagnostic imaging or interpretation devices where human performance is being evaluated, and is not relevant for a calibrator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This information is not applicable/not provided. The device is a calibrator, not an algorithm.
7. The Type of Ground Truth Used
For a calibrator, the "ground truth" would be the assigned value of the analytes (HbA1c in this case) at each level of the calibrator. This value is established through highly accurate reference methods and/or traceability to international reference materials. The document implies this "ground truth" is reliably established, making the calibrator suitable for its intended purpose.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This concept applies to machine learning algorithms, not to a medical calibrator.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided.
In summary: The provided 510(k) summary for the C.f.a.s. HbA1c calibrator is a submission focused on demonstrating substantial equivalence to a predicate device. It highlights the physical, chemical, and functional similarities, and explains the differences (such as handling, levels, and stability conditions) without presenting specific, quantitative performance study data or details on "acceptance criteria" as they might apply to a diagnostic or therapeutic device. The "study" here is the comparison to the predicate device, asserting that the new device performs equivalently for its intended use as a calibrator.
§ 864.8165 Calibrator for hemoglobin or hematocrit measurement.
(a)
Identification. A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.