(21 days)
As a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents.
The KAMIYA Immunology Control is a liquid-stable, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents. Two levels of the KAMIYA Immunology Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to CV and HIV. The assigned values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The product is stable for at least 1 year (unopened) and 1 month (after opening).
The Kamiya Biomedical Company's Immunology Control is a liquid-stable, human serum-based, assayed control intended for monitoring the performance of immunoturbidimetric assays for various constituents.
1. Acceptance Criteria and Reported Device Performance:
The document states that the safety and effectiveness of the KAMIYA Immunology Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202). The key acceptance criteria and reported performance are based on comparison to this predicate device.
| Acceptance Criteria | Reported Device Performance (KAMIYA Immunology Control) |
|---|---|
| Substantial Equivalence to Predicate Device (Sigma Immunology Control K851202) | Achieved |
| Similar within-run precision for 10 analytes tested | Demonstrated |
| Similar between-day precision for 10 analytes tested | Demonstrated |
| Similar reaction characteristics for 10 analytes tested | Demonstrated |
| Stability (unopened) | At least 1 year |
| Stability (after opening) | At least 1 month |
| Negative for HBsAg, antibody to CV, and HIV (human serum source) | Tested and found negative |
| Traceable to CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum (assigned values) | Achieved |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample size used for the performance evaluation. It mentions "10 analytes tested," implying that the comparison for precision and reaction characteristics was performed across these analytes.
The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission, it would typically involve prospective testing conducted by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information about the number of experts used or their qualifications for establishing ground truth as it relates to the performance study. The ground truth for the assigned values is stated to be traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum, which implies established, standardized reference methods and materials are used.
4. Adjudication Method:
The document does not mention an adjudication method for a test set in the context of expert consensus or disagreement. The evaluation relies on direct comparisons of performance characteristics against a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is an in-vitro diagnostic control, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.
6. Standalone Performance Study:
A standalone performance study was performed in the sense that the KAMIYA Immunology Control's own precision and reaction characteristics were measured and then compared to those of the predicate device to demonstrate substantial equivalence. The "algorithm" here refers to the function of the control itself, rather than a software algorithm.
7. Type of Ground Truth Used:
The ground truth for the assigned values of the control is established by traceability to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. For the performance evaluation (precision and reaction characteristics), the "ground truth" is effectively derived from the established performance of the legally marketed Sigma Immunology Control (K851202), against which the new device is compared for substantial equivalence.
8. Sample Size for the Training Set:
This concept is not applicable. The device is a diagnostic control, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This concept is not applicable as there is no training set for this device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.