(222 days)
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.
The Ceruloplasmin reagent kit is in a liquid, ready to use form. It is available in one format OSR6164 which consists of 4 x 18mL R1 vials and 4 x 5ml R2 vials. The calibrator is a Beckman Coulter Serum protein multi-calibrator ODR3023 which is sold separately. Ceruloplasmin is a turbidimetric method the basis for this method is the measurement of the decrease in light transmitted (increase in absorbance) through the particles suspended in solution as a result of complexes formed during the antigen-antibody reaction. The Ceruloplasmin reagent is designed for optimal performance on the Beckman Coulter AU analyzers.
Here's a breakdown of the acceptance criteria and study information for the Beckman Coulter Ireland Inc. Ceruloplasmin reagent, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance | Meet Criteria |
|---|---|---|
| Method Comparison | ||
| Slope: 0.900-1.100 | 1.056 | Pass |
| Intercept: ≤ ± 30mg/L | -26.10mg/L | Pass |
| r: ≥0.975 | 0.990 | Pass |
| N: ≥100 | 120 | Pass |
| Within Run Precision | ||
| Pool 1 (95.99 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 1.10% CV (1.042 SD) | Pass |
| Pool 2 (148.36 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 1.10% CV (1.70 SD) | Pass |
| Pool 3 (254.17 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.90% CV (2.30 SD) | Pass |
| Pool 4 (596.43 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.90% CV (5.46 SD) | Pass |
| Pool 5 (915.61 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.7% CV (6.78 SD) | Pass |
| Pool 6 (1791.94 mg/L): ≤5% CV or SD ≤1 mg/dL (10mg/L) | 0.5% CV (9.52 SD) | Pass |
| Total Precision | ||
| Pool 1 (95.99 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 6.7% CV (6.44 SD) | Pass |
| Pool 2 (148.36 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 2.80% CV (4.09 SD) | Pass |
| Pool 3 (254.17 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 2.20% CV (5.70 SD) | Pass |
| Pool 4 (596.43 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 1.90% CV (11.36 SD) | Pass |
| Pool 5 (915.61 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 1.6% CV (14.51 SD) | Pass |
| Pool 6 (1791.94 mg/L): ≤10% CV or SD ≤2 mg/dL (20mg/L) | 1.4% CV (25.23 SD) | Pass |
Study Details:
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Sample size used for the test set and the data provenance:
- Method Comparison: 120 samples. The document does not specify the country of origin or whether the data was retrospective or prospective.
- Precision Study: The report lists 6 "pools" with varying concentrations. The number of individual samples within each pool or the total number of samples used for the precision study is not explicitly stated beyond what is implied by the "Pool" structure. The data provenance is also not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a chemistry test system (in vitro diagnostic reagent) for quantitative determination of ceruloplasmin. The ground truth (reference values) for the method comparison study was established using a predicate device, the Siemens N Antisera to Human Ceruloplasmin. For precision, the ground truth is based on the inherent variability measurements of the device itself.
- Therefore, the concept of "experts establishing ground truth" in the way it might apply to image-based diagnostic AI is not directly applicable here. No human experts are explicitly mentioned as establishing the ground truth for these quantitative measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This device provides quantitative measurements, which are directly compared to values obtained from a predicate device or assessed for statistical precision, rather than requiring subjective expert adjudication of qualitative interpretations.
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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:
- No. This is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, essentially. The stated performance data (Method Comparison, Precision) reflects the standalone performance of the Ceruloplasmin reagent system on Beckman Coulter AU analyzers without direct human intervention in the result generation process, beyond operating the analyzer and performing necessary calibration/quality control.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the Method Comparison study, the ground truth was established by another legally marketed predicate device: Siemens N Antisera to Human Ceruloplasmin. This is a form of comparative ground truth against an established method.
- For the Precision study, the ground truth is statistical, derived from repeated measurements of samples to quantify variability relative to the mean of those measurements.
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The sample size for the training set:
- This document describes a 510(k) premarket notification for an in-vitro diagnostic reagent. It does not refer to a "training set" in the context of machine learning or AI. The development process for such a reagent would involve internal verification and validation studies during manufacturing, but these are not typically referred to as "training sets" in the same way as for AI. The document only reports performance data, not development data.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" described in the context of AI. For the development and validation of an IVD reagent, ground truth would be established through a combination of using certified reference materials, comparison to existing gold standard methods, and defined analytical protocols to ensure accuracy and precision. However, these specific details are not provided in this 510(k) summary.
§ 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.