(69 days)
Dimension Vista™ CER Flex® reagent cartridge: The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista" Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista™ CER Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the Dimension Vista™ CER assay are based on demonstratincorr correlation and equivalent performance with the predicate device (Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System). While explicit numerical thresholds for acceptance (e.g., minimum correlation coefficient, maximum acceptable slope/intercept deviation) are not provided, the reported performance is presented to demonstrate that these criteria have been met.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient | High correlation with predicate system (N Antisera on BN ProSpec®) | 0.994 |
| Slope | Close to 1.0 (relative to predicate system) | 1.009 |
| Intercept (g/L) | Close to 0.0 (relative to predicate system) | 0.008 |
2. Sample Size and Data Provenance:
- Test Set Sample Size: 130 samples.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It states "evaluating serum and plasma samples," implying collection for the purpose of the study, which could suggest prospective, but this is not explicitly confirmed.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This study involves a direct comparison of a new assay against a legally marketed predicate assay, not against a ground truth established by experts interpreting various forms of data (e.g., images, clinical symptoms). The "ground truth" or reference for comparison is the performance of the predicate device.
4. Adjudication Method:
Not applicable. There was no need for adjudication as the study directly compares quantitative assay results from two different systems.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study is a method comparison for an in vitro diagnostic (IVD) assay, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was conducted in the sense that the Dimension Vista™ CER assay's performance was directly measured and compared against the predicate device. This is typical for IVD device submissions, where the "standalone" performance refers to the device's output without human interpretation in the results generation process. The comparison is between the Dimension Vista™ CER assay results and the predicate assay results for the same samples.
7. Type of Ground Truth Used:
The "ground truth" for this method comparison study is the results obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human Ceruloplasmin assay on the BN ProSpec System. This is a common approach for demonstrating substantial equivalence for new IVD assays.
8. Sample Size for the Training Set:
Not applicable. This is a method comparison study for an IVD device, not a machine learning model that requires a "training set." The device is a reagent cartridge and calibrator system for a laboratory instrument, not an AI algorithm learned from data.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set for this type of device and study.
§ 866.5210 Ceruloplasmin immunological test system.
(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(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 § 866.9.