(191 days)
COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
Indications For Use:
COBAS INTEGRA:
In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Roche/Hitachi cobas c systems:
In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative immunological determination of human ceruloplasmin in serum and plasma. The calibrator and control were cleared via K954992.
Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
The test principle is an immunoturbidimetric assay. The calibrator is Serumproteins T Standard and the recommended control material is the Serumproteins T Control.
Here's a breakdown of the acceptance criteria and study information for the COBAS INTEGRA Ceruloplasmin device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Predicate Device (0.06-1.3 g/L) | COBAS INTEGRA Ceruloplasmin (Acceptance Criteria/Performance) |
|---|---|---|
| Measuring Range | 0.06-1.3 g/L | 0.06-1.26 g/L (Reported performance, implying this is the accepted range for the device) |
| Lower Detection Limit | 0.02 g/L | 0.017 g/L (Reported performance, implying this is the accepted limit for the device). This is an improvement compared to the predicate device. |
| Expected Values | 0.2-0.6 g/L | 0.2-0.6 g/L (Same as predicate, implying this is the accepted range for normal values) |
| Precision (Within run total CV%) | ||
| At ~0.2-0.27 g/L | 1.0% @ 0.27 g/L | 3.88% @ 0.2 g/L (Reported performance) |
| At ~0.34-0.35 g/L | 1.4% @ 0.34 g/L | 2.66% @ 0.35 g/L (Reported performance) |
| At ~0.62 g/L | 1.6% @ 0.62 g/L | (No corresponding data point provided for COBAS INTEGRA Ceruloplasmin) |
| Linearity | 0.06-0.69 g/L | 0.06-1.26 g/L (Reported performance, implying this is the accepted linear range for the device. This is an improvement compared to the predicate device.) |
| Endogenous Interferences | ||
| Hemolysis | no interferences up to 10 g/L | no significant interferences (Reported performance, implying this is the accepted level of interference) |
| Icterus | no interferences up to 600 mg/L | no significant interferences (Reported performance, implying this is the accepted level of interference) |
| Triglycerides/Lipemia | no interferences up to 25 g/L | no significant interferences (Reported performance, implying this is the accepted level of interference) |
| Rheumatoid factors | (Not mentioned) | no significant interferences up to 400 IU/mL (Reported performance) |
| Exogenous Interferences | (Not mentioned) | Gammopathy, in particular IgM, may cause unreliable results in rare cases (Reported, implying this is an accepted limitation) |
| Method Comparison (vs. DakoCytomation Anti Human Ceruloplasmin) | y = 1.0x - 0.0 g/L; r = 0.987 | y = 1.0x - 0.0 g/L; r =0.987 (Reported, implying agreement with the predicate is the accepted criterion) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for validating each performance characteristic (e.g., precision, linearity, interference studies, or method comparison). The data provenance is not specified regarding country of origin or an explicit retrospective/prospective design. However, the context of a 510(k) submission for a new in vitro diagnostic (IVD) device typically implies prospective testing conducted by the manufacturer, likely at their facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic (IVD) assay for a quantitative biomarker (ceruloplasmin). The "ground truth" for such devices is established by analytical methods and comparison to a predicate device or reference material, not by expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as this is an IVD assay, not a device requiring human interpretation and adjudication of results. The method comparison refers to the statistical comparison of results from the new device against the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is an algorithm-only (standalone) performance. The device is a fully automated immunoturbidimetric assay system that quantitatively determines ceruloplasmin levels. There is no human intervention in the result generation process; the result is directly reported by the instrument.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is established through:
- Reference materials: The device "Standardized against IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) for 14 serum proteins." This reference material serves as a "ground truth" for calibrating the assay.
- Comparison to a legally marketed predicate device: The method comparison data shows results against the DakoCytomation Polyclonal Rabbit Anti-Human Ceruloplasmin (K812486), which serves as a clinical benchmark (or "ground truth" in terms of clinical performance equivalence).
8. The Sample Size for the Training Set
Not explicitly stated. For IVD devices, a "training set" in the context of machine learning is not directly applicable. The "training" here refers to the development and optimization of the reagent formulation and assay parameters. The document doesn't provide specific sample sizes for these development phases.
9. How the Ground Truth for the Training Set Was Established
Not explicitly stated in the document. For IVD assays, the "ground truth" for development and optimization (analogous to training) would typically involve:
- Using known concentrations of ceruloplasmin (e.g., from purified human ceruloplasmin or spiked samples).
- Testing against established reference methods or highly characterized samples.
- Performing extensive analytical verification during the development phase to ensure the assay performs as intended across its measuring range and with various interference challenges.
§ 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.