(49 days)
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardioPhase® high sensitivity C-reactive protein (Cat. No. RC434) method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
The high sensitivity C-reactive protein Calibrator is a liquid bovine serum albumin-based product. Levels 2 -5 contain a human C-reactive protein.
Here's a breakdown of the acceptance criteria and study information for the Dimension® CardioPhase® high sensitivity CRP Calibrator (CCRP Calibrator - RC434), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stability (Shelf Life) | "Linear regression across the shelf life interval for each test sample versus test day will have non-significant slopes (p> 0.05) or observed drift within +/-5% for non-zero samples and +/-0.05 mg/L at 0 mg/L CRP over a 12 month interval. The shelf life of the product will be 6 months after the successful completion of 7 months of real time stability on three lots of product." | The document states, "The shelf life of the product will be 6 months after the successful completion of 7 months of real time stability on three lots of product." This implies the acceptance criteria were met by passing this stability study, but the specific performance data (e.g., actual slopes, drift percentages) is not explicitly detailed in the provided summary. The approval of the 510(k) suggests compliance. |
| Traceability | Calibrator values are standardized to IFCC, BCR, and CAP reference preparations (specifically Lot No. 91/0619=CRM470=RPPHS 91/0619). | "The assigned values of the CCRP calibrator are standardized to the International Federation of Clinical Chemistry (IFCC) International Reference Preparation for Plasma Proteins, the Community Bureau of Reference (BCR) and the College of American Pathologists (CAP). The basis of this international standardization is the IFCC/BCR/CAP reference preparation for 14 human serum proteins (Lot No. 91/0619=CRM470=RPPHS 91/0619) (lot V)." (This indicates the criteria were met.) |
| Value Assignment | "The acceptable recovery of an approved CCRP Calibrator lot must be obtained." | "Three Dimension® clinical chemistry analyzers are calibrated with the approved CCRP Masterpool. The acceptable recovery of an approved CCRP Calibrator lot must be obtained. Test calibrator levels are then tested on three separate analyzers with different CCRP flex lots. The grand mean of all 5 replicate test means of all 9 curves is the value assignment for each Calibrator Level." (This describes the method for value assignment, which implies it's performed to ensure acceptable recovery, but doesn't provide specific numerical performance data.) |
2. Sample Sized Used for the Test Set and Data Provenance
The provided document does not explicitly define a "test set" in the traditional sense for assessing diagnostic performance against an external reference. Instead, the studies described are related to the calibrator's internal performance (stability, traceability, and value assignment).
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Stability Study:
- Sample Size: "three lots of product" were used for real-time stability testing.
- Data Provenance: The data is implicitly prospective, as it involves real-time monitoring of the product's stability. The country of origin of the data is not specified but is presumably where Dade Behring Inc. conducts its manufacturing and testing, which is in the USA (Newark, DE).
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Value Assignment Study:
- Sample Size: "Three Dimension® clinical chemistry analyzers" and "different CCRP flex lots" (number of lots not specified beyond "different"), with "5 replicate test means of all 9 curves" implying a total of 45 measurements per calibrator level in this specific part of the assignment process.
- Data Provenance: Implicitly prospective and internal to the manufacturer. Country of origin not specified, but likely USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a calibrator, the "ground truth" is established by its direct traceability to recognized international reference standards (IFCC/BCR/CAP CRM 470), not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as there's no "test set" in the clinical diagnostic sense requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., imaging devices, pathology slides). The device in question is a calibrator, which provides known concentrations for calibrating an automated assay.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the performance characteristics described are "standalone" in the sense that they evaluate the calibrator material itself and its interaction with the Dimension® clinical chemistry system, without direct human intervention in the result generation or interpretation after the initial setup. The calibrator's function is to provide known reference points for an automated assay.
7. The Type of Ground Truth Used
The ground truth for the calibrator's values is based on traceability to internationally recognized reference materials.
- For the Calibrator values: IFCC/BCR/CAP reference preparation for 14 human serum proteins (Lot No. 91/0619=CRM470=RPPHS 91/0619). This is a highly standardized and globally accepted reference material.
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is generally used for machine learning algorithms. This device is a calibrator for a traditional immunoassay system and does not involve an 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 for this device.
§ 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.