(105 days)
Calibrator for automated systems (C.f.a.s) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
C.f.a.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.
- C.f.a.s. is for use in the calibration for automated Roche methods on Roche chemistry analyzers as specified in the enclosed value sheet. It is a lyophilized calibrator based on human serum.
- C.f.a.s. CK-MB is for use in the calibration of Roche methods for the quantitative determination of the MB Isoenzyme of Creatine kinase on automated clinical chemistry analyzers. It is a lyophilized calibrator based on bovine serum albumin.
The provided text describes modifications to two calibrator devices, Calibrator for automated systems (C.f.a.s.) and C.f.a.s. CK-MB, and establishes substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a performance study report for diagnostic devices. The document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., accuracy, precision targets) for the modified calibrators or report specific device performance against such criteria. It primarily focuses on comparing features and source materials to demonstrate substantial equivalence to previously cleared devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) Summary. Performance data (if collected) would typically be in a separate study report, which is not part of this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not relevant to a calibrator device and is not provided. Ground truth for calibrators is typically established through reference methods and reference materials, not expert consensus as in image-based diagnostics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not relevant to a calibrator device and is not provided.
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 type of study is not relevant to a calibrator device and was not conducted. The devices are calibrators for automated chemistry analyzers, not AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI algorithm performance studies, which are not relevant to these calibrator devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For calibrators, the "ground truth" or reference values are established through reference materials and reference methods, as noted in the "Traceability" section:
- C.f.a.s.: Uses Reference Materials like SRM 909b, SRM 956, SRM 929, SRM 914, SRM 967, SRM 1951, ERM DA470k, and USP Primary Reference Material. It also references updated IFCC Manuals for various enzymes as reference method publications.
- C.f.a.s. CK-MB: The traceability is described as being "described in the reagent system instructions for use," and value assignment is performed by running new lots against previously assigned lots and verifying with reference material, Master lot C.f.a.s. CK-MB, and previously assigned lots.
8. The sample size for the training set
This is not applicable as this is a calibrator device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
Summary of Provided Information:
The 510(k) Summary describes modifications to two calibrator devices (C.f.a.s. and C.f.a.s. CK-MB) primarily involving changes in the source materials for certain analytes. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K062319 for C.f.a.s. and K003158 for C.f.a.s. CK-MB).
- C.f.a.s. modifications: Human recombinant Gamma-glutamyltransferase (γGT) replaces porcine kidney γGT; Human recombinant Aspartate aminotransferase (AST) replaces porcine heart AST.
- C.f.a.s. CK-MB modifications: Human recombinant Creatine Kinase Isoenzyme MB (CK-MB) replaces porcine brain Creatine Kinase Isoenzyme BB (CK-BB).
The document does not report specific acceptance criteria or a study demonstrating the modified devices meet new performance targets because the purpose of a 510(k) Summary for such device modifications is to show that the changes do not raise new questions of safety and effectiveness and that the modified device is substantially equivalent to an existing legally marketed device. The focus is on comparing features, intended use, format, stability, levels, reagent composition, traceability, value assignment, and source materials with the predicate devices.
§ 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.