(45 days)
The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 analysers. For In Vitro Diagnostic use only.
The System calibrator kit is a lyophilized human serum based product intended to provide calibration for AU Enzyme reagents (ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH) for the quantitative determination of the relevant analyte on Beckman Coulter AU analyzers. The following is the kit configuration for the system calibrator: 66300 kit has 20 vials with 5 ml contents for Level 1. The System calibrator is designed for optimal performance on Beckman Coulter AU analyzers. The System calibrator contains lyophilized human serum with chemical additives, preservatives, and enzymes of human, animal and plant origin.
This document describes the Beckman Coulter System Calibrator (66300), a lyophilized human serum-based product intended for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT, and LDH enzymes on Beckman Coulter AU480, AU680, and AU5800 analyzers.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | ≤ ±5% drift | 8 hours @ 2-8°C (meets criteria) |
| Shelf Life Stability | ≤ ±5% drift | 36 months @ 2-8°C (meets criteria, tested for 36 months plus at least one month after expire date claim) |
2. Sample Size Used for the Test Set and Data Provenance
- Open Vial Stability: 3 individual calibrator lots.
- Shelf Life Stability: 3 individual lots of calibrator.
- Value Assignment: Multiple reagent lots and calibrator vials were used. 10 replicates from 8 runs were performed, resulting in a total of 80 data points per individual enzyme. Distinct runs with minimum gaps of 2 hours were performed, and 8 calibration events were used.
The data provenance is not explicitly stated in terms of country of origin. The studies appear to be internal validation studies conducted by Beckman Coulter Ireland, Inc. and may be considered prospective as they were specifically designed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device. The ground truth for this calibrator is based on analytical performance specifications and traceability to theoretical extinction coefficients, not expert consensus interpretation.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. This device is a calibrator for in vitro diagnostic assays, and its performance is evaluated through quantitative analytical methods and stability testing, not through expert adjudication of qualitative outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not relevant for this device. This product is a calibrator, not an imaging or diagnostic algorithm requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, in the sense that the performance characteristics (stability, value assignment) are determined directly from the calibrator's analytical behavior on Beckman Coulter AU analyzers without human intervention in the result determination process. The "device" (calibrator) performs its function (calibrating assays) independently of human judgment on the results, although human operators perform the testing.
7. The Type of Ground Truth Used
The ground truth for the System Calibrator's values and performance is established through:
- Analytical Performance Specifications: The device's stability (open vial and shelf life) is evaluated against a maximum allowable drift of ±5%.
- Traceability to Theoretical Extinction Coefficients: The assigned values for each enzyme are traceable to specific theoretical extinction coefficients (e.g., Amylase OSR6x06: 11320, ALP OSR6x04: 17900), which are fundamental physicochemical properties.
- Internal Test Procedures and Protocols: Value assignment was determined utilizing internal procedures and protocols that involved multiple reagent lots and calibrator vials.
8. The Sample Size for the Training Set
Not applicable. This document describes a calibrator, not a machine learning or AI model that requires a training set. The "training" in this context refers to the calibration of an analyzer using the calibrator, not the development of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. For the calibrator's value assignment, the ground truth was established by calculating the overall mean from 80 data points (10 replicates from 8 runs) for each individual enzyme, ensuring incorporation of variation from calibration and environmental sources, and tracing these values to theoretical extinction coefficients.
§ 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.