(64 days)
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.
Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.
The provided document is a 510(k) clearance letter for the Randox Calibration Serum, a Class II medical device. It does not contain information regarding detailed acceptance criteria, device performance studies, or the methodologies typically associated with assessing the clinical accuracy or effectiveness of diagnostic devices in the way requested in the prompt.
The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance. It lists the analytes the calibration serum is intended to measure and clarifies its use as an in vitro diagnostic product for calibration in clinical chemistry assays. It does not describe a study that proves the device meets specific performance acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or how it impacts human reader performance, as would be relevant for an AI-powered diagnostic device.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
Here's a breakdown of why the requested information is not available in the provided text:
- Acceptance Criteria & Reported Performance: This document states the device is intended for use as a calibration serum and its concentrations and activities are suitable for calibration. It does not provide specific numerical acceptance criteria (e.g., within a certain percentage of a reference value) for its calibration accuracy, nor does it report specific performance metrics like bias, precision, or recovery rates that would typically be evaluated for a calibrator. The regulatory submission would have included analytical performance data, but that data is not part of this clearance letter.
- Sample Size (Test Set) & Data Provenance: Not applicable in the context of this document. Calibrators are tested for their stability, accuracy of assigned values, and matrix effects, not against a "test set" in the sense of patient samples for diagnostic performance.
- Number of Experts & Qualifications (Ground Truth): Not applicable for a calibration serum. The "ground truth" for a calibrator is typically established through reference methods and certified reference materials, not expert consensus on patient data.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study evaluates the impact of an AI algorithm on human diagnostic performance, which is not relevant for a calibration serum.
- Standalone (Algorithm Only) Performance: Not applicable. The device is a physical reagent (calibration serum), not an algorithm.
- Type of Ground Truth Used: The "ground truth" for a calibration serum's values would be based on validated reference methods and certified reference materials, ensuring traceability to primary standards. This is not explicitly detailed in the clearance letter.
- Sample Size for Training Set: Not applicable. This device is not an AI model that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, the provided text from the FDA 510(k) clearance letter for a calibration serum does not contain the information requested in the prompt because the prompt's questions are designed for evaluating diagnostic devices, particularly AI/machine learning-based ones, and not for a calibration standard.
§ 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.