(35 days)
Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet.
Calibrator for Automated Systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet. Calibrator for Automated Systems (C.f.a.s.) is a lyophilized calibrator based on human serum.
This 510(k) submission describes modifications to an existing calibrator device, the Calibrator for Automated Systems (C.f.a.s.). It focuses on demonstrating substantial equivalence to the predicate device (K033501) rather than a comprehensive de novo study with acceptance criteria and a detailed study report comparing the device's performance against those criteria. Therefore, much of the requested information regarding an acceptance criteria study in the typical sense (e.g., sample size, ground truth, expert opinions, MRMC studies, standalone performance) is not directly present.
However, based on the provided text, we can infer some "acceptance criteria" through the modifications and the declaration of conformity to design controls, and describe the "study" as the validation activities conducted under design control.
Here's an attempt to address your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a modification submission, the "acceptance criteria" are implied by demonstrating that the modified device's performance, particularly its stability and traceability, remains appropriate for its intended use and is substantially equivalent to the predicate. The "reported device performance" is the successful outcome of the validation and development activities.
| Acceptance Criteria (Implied) | Reported Device Performance (as per submission) |
|---|---|
| Intended Use/Indications for Use: Remain unchanged from predicate. | Same as predicate. (Paragraph 1, Table: Similarities/Differences) |
| Reagent Composition: Changes (addition of pyridoxal phosphate) do not negatively impact performance or intended use. | Pyridoxal-phosphate addition acknowledged. (Paragraph 1, Table: Similarities/Differences). Overall, the modification "does not alter the fundamental scientific technology of the device." (Paragraph 3, Closing). The implication is that the performance is maintained. |
| Stability (Reconstituted): New stability claim (4 weeks frozen) for reconstituted product is supported. | Reconstituted stability claimed: 4 weeks (frozen once) at (-15) to (-25)° C (increased from 2 weeks for predicate). (Paragraph 1, Table: Similarities/Differences). The "overall product specifications were met" through Validation and Development activities under design control. (Paragraph 2, Validation and Development activities). |
| Traceability: Modifications to traceability for specific analytes maintain accuracy and consistency. | Traceability changed for specific analytes: Direct Bilirubin, Calcium, Creatinine, Iron, Magnesium, UIBC, Uric Acid. (Paragraph 2, Table: Similarities/Differences). The "overall product specifications were met" through Validation and Development activities under design control, implying the new traceability methods are adequate. |
| Value Assignment Procedure: Modified procedure ensures accurate and consistent value assignment for new lots. | Modified value assignment procedure: Values to new lots assigned by running as samples after calibrating with previously assigned C.f.a.s. lot, then verified using reference material, Master lot C.f.a.s., and previously assigned lots. This is a change from the predicate's method of calibrating with the Master Lot. (Paragraph 2, Table: Similarities/Differences). The "overall product specifications were met" through Validation and Development activities under design control, indicating this new procedure is acceptable. |
| Overall Product Specifications: All product specifications are met following modifications. | Overall product specifications were met. (Paragraph 2, Validation and Development activities) |
| Conformity to Design Controls and Risk Analysis: Deviations from the predicate are managed according to design control. | Declaration of Conformity with Design Controls and Results of Risk Analysis are provided. (Paragraph 2, Validation and Development activities) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical or analytical study with a distinct sample size for this 510(k) modification. The validation and development activities would have involved various measurements and comparisons, but specific sample sizes for these internal studies are not detailed.
- Data Provenance: The studies were conducted internally by Roche Diagnostics Corporation, likely at their Indianapolis, IN (USA) facility. The nature of the data would be laboratory-generated analytical data from the calibrator. The studies are prospective in the sense that they were conducted for this device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to the analytical performance testing of a calibrator. "Ground truth" for a calibrator is established through highly controlled, traceable analytical methods and reference materials, not typically through a panel of human experts. The data supporting the performance reflects the analytical measurements themselves.
4. Adjudication Method for the Test Set
Not applicable, as human expert adjudication is not relevant for establishing the performance of an analytical calibrator.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This device is an analytical calibrator, not an imaging device or diagnostic tool that requires human interpretation. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a chemical calibrator. The calibrator itself is a "standalone" product that performs its function (calibration) without human "interpretation" of its result in the way an algorithm might. Its performance is measured analytically.
7. The Type of Ground Truth Used
The ground truth for a calibrator’s performance (e.g., the accuracy of its assigned values and its stability) is established through:
- Reference materials: Highly characterized substances with known, accurate concentrations or properties.
- Reference methods: Established, validated analytical procedures known to provide accurate results.
- Traceability: The ability to link the measurements to national or international standards.
The document explicitly states "Traceability through standards or reference methods analyzed at all set point validation runs" and "Values are verified by using reference material, Master lot C.f.a.s. and previously assigned lots of C.f.a.s." (Paragraph 2, Table: Similarities/Differences).
8. The Sample Size for the Training Set
Not applicable. This device is a calibrator, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set."
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 § 862.9.