Search Results

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

Study Details:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Ask a specific question about this device

The Human Ceruloplasmin Kit for use on SPAPlus is intended for the quantitative in vitro measurement of human ceruloplasmin in serum using the SPAPLUS turbidimetric analyser. The measurement of ceruloplasmin levels in serum is an aid in the diagnosis of copper metabolism disorders. This test should be used in conjunction with other laboratory and clinical findings.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document describes an FDA 510(k) clearance letter for a "Human Ceruloplasmin Kit for use on SPAPLUS," outlining its intended use and regulatory classifications. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm-only) performance.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device

In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinization of only and one of immunonephelometry on the BN™ Systems.
In vitro diagnostic reagents for the quantitative determination of ceruloplasmin and hemopexin in serum and heparinized plasma by means of immunonephelometery on the BN™ Systems. Measurement of ceruloplasmin aids in the diagnosis of cooply of metabolism disorders.

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 relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

This document describes the 510(k) summary for the "N Antisera to Human Ceruloplasmin" device, which is an in vitro diagnostic reagent used for the quantitative determination of ceruloplasmin and hemopexin in human serum and heparinized plasma. The submission claims substantial equivalence to a legally marketed predicate device (K860894).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative format for specific performance metrics like accuracy, precision, or detection limits. Instead, it focuses on demonstrating equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document mentions "a method comparison was performed" but does not give the number of samples or subjects used in this comparison.
• Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable as this is an in vitro diagnostic reagent claiming equivalence, not a medical imaging or clinical diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable for a chemistry assay where the "ground truth" is typically established by reference methods or comparison to a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC study was not performed. This type of study is relevant for devices involving human interpretation of medical images or data. This device is an automated in vitro diagnostic reagent.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, this device operates as a standalone diagnostic reagent on the BN™ Systems. Its performance is evaluated based on its ability to quantitatively determine ceruloplasmin and hemopexin levels, without requiring human interpretation of results beyond reading the quantitative output. The "method comparison" study conducted is essentially a standalone performance evaluation against a comparable method.

7. The Type of Ground Truth Used:

• The ground truth for this device's performance evaluation is established through comparison to a legally marketed predicate device (K860894), and by demonstrating correlation between different sample types (serum and heparinized plasma). The predicate device itself would have been validated against established reference methods or clinical outcomes.

8. The Sample Size for the Training Set:

• Not applicable. This device is an in vitro diagnostic reagent, not an AI/ML algorithm that undergoes a "training" phase with a dataset. Its development likely involved R&D, formulation, and analytical validation.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no "training set" in the context of this traditional in vitro diagnostic reagent.

Ask a specific question about this device

The IMMAGE Immunochemistry System Ceruloplasmin (CER) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human ceruloplasmin by rate nephelometry.

The IMMAGE Immunochemistry System CER Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of ceruloplasmin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for stability and imprecision are implied by the nature of these tests in diagnostic device validation. The document states that the data "supports a finding of substantial equivalence," which suggests that these performance metrics met the internal or regulatory thresholds for equivalence.

2. Sample size used for the test set and the data provenance

• Method Comparison Test Set Sample Size: 104 serum samples.
• Imprecision Test Set Sample Size: For each of the five serum levels tested, 80 data points were collected for "Within Run" and "Total" precision, and 30 data points for the "Low Serum Levels". This refers to the number of individual measurements or replicates.
• Data Provenance: The document does not explicitly state the country of origin. It is a submission by Beckman Instruments, Inc. in Brea, California, USA, so it's most likely US-based data, but this is not confirmed. The studies are prospective in nature, as they involve testing the device's performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. For an immunochemistry system that quantifies ceruloplasmin, the ground truth would typically be established by a reference method or a predicate device. The document uses a predicate device (Beckman Array Systems CER Reagent) as the reference for the method comparison, rather than expert consensus on individual results.

4. Adjudication method for the test set

• This information is not applicable and therefore not provided in the document. Adjudication is typically used when there are subjective interpretations (e.g., medical imaging) requiring multiple experts to reach a consensus. For a quantitative immunoassay, the "ground truth" is derived from a reference measurement or predicate assay, not through expert adjudication of individual results.

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

• This information is not applicable and therefore not provided in the document. MRMC studies are specific to diagnostic devices where human readers (e.g., radiologists) interpret results, often with and without AI assistance. This device is a fully automated immunochemistry system for quantitative measurement, not an AI-assisted diagnostic tool for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Yes, the studies presented (Method Comparison and Imprecision) represent the standalone performance of the IMMAGE™ Immunochemistry System Ceruloplasmin (CER) Reagent. The system is designed for automated quantitative determination, meaning it operates without human intervention in the result generation process once the sample is loaded and the assay initiated. The reported performance metrics are for the device itself.

7. The type of ground truth used

• The ground truth for the method comparison study was established by the predicate device, the Beckman Array Systems CER Reagent. This means the IMMAGE System's results were compared against the established results from an already approved and commercially distributed device to demonstrate substantial equivalence. For imprecision, the "ground truth" is internal consistency and reproducibility of the device itself.

8. The sample size for the training set

• This information is not provided in the document. This device is an immunochemistry assay, not a machine-learning or AI-based system that typically requires a distinct "training set" for model development. The development process would involve formulation, optimization, and internal testing, but not in the same sense as an AI algorithm's training phase.

9. How the ground truth for the training set was established

• This information is not provided and is not applicable in the context of this type of diagnostic device. As explained above, there isn't a "training set" in the machine learning sense for this immunochemistry system. The development and validation process would rely on established analytical chemistry principles and performance characteristics, rather than data-driven model training.

Ask a specific question about this device