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The IBL Catecholamine RIA test kits are for the in-vitro-diagnostic quantitative determination r fre lDE Suttonnines adrenaline (epinephrine), noradrenaline (norepinephrine) and/or dopamine (either separate or combined) in human plasma and urine. The Catecholamine test kits are useful as an aid in the diagnosis as well as the follow-up of r he Galecholanine tool hits are asserally of the pheochromocytoma, but also the neuroblastoma and the ganglioneuroma.

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I am sorry but this document does not contain the requested information. The document is a 510(k) premarket notification letter from the FDA regarding several RIA test kits for catecholamines. While it mentions the device names, regulation numbers, and intended use, it does not provide details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the scientific study reports or summary of safety and effectiveness, which are not included here.

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The ESA Plasma Free Metanephrine Analysis Kit is intended for use in clinical laboratories that hold a CLIA certificate to perform tests of high complexity to measure endogenous free levels of the metanephrines (normetanephrine and metanephrine) in plasma using high performance liquid chromatography with electrochemical detection. The analysis of these analytes is used in the differential diagnosis of adult male and female patients with pheochromocytoma. For In Vitro Diagnostic Use Only.

The ESA Free Plasma Motanephrine Analysis Kit consists of reagents for the extraction of metanephrines (normetanephrine and metanephrine) sufficient for 100 plasma samples. Sample clean-up is achieved with ion exchange solid phase extraction. The final extracts are ovaporated to dryness, reconstituted and analyzed via reversed phase ion-pair high performance liquid chromatography and electrochemical detection using the ESA CoulArray® detector. The multichannel electrode system oxidizes the metanepluines and the internal standard, 4-Hydroxy-3-mothoxybenzlamine (HMBA), followed by reduction at a downstream electrode. Total chromatographic run time is approximately 28 minutes per sample. Quantitative data analysis and report generation is performed using ESA CoulArray for Windows Data Station.

The provided document is a 510(k) summary for the ESA Plasma Free Metanephrine Analysis Kit. It describes the device, its intended use, and states that its performance and reliability have been verified. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes (for test or training sets), expert qualifications, ground truth establishment methods, or comparative effectiveness studies.

Therefore, I cannot populate most of the requested fields. The document confirms a "standalone" performance assessment was done, as it verifies the assay's performance.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified in the document. The document mentions "plasma samples, augmented plasma samples, standards and controls" were used.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. This is a diagnostic kit; the "ground truth" for its performance would typically be based on established analytical methods and clinical correlations, not necessarily expert image interpretation.

4. Adjudication method for the test set:

• Not applicable/Not specified. This refers to consensus among human readers, which is not relevant for an in vitro diagnostic (IVD) assay performance study described here.

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 typically for evaluating the impact of AI on human reader performance for tasks like image interpretation, which is not applicable to this IVD kit.

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

• Yes, a standalone performance assessment was done. The document explicitly states: "Through the use of plasma samples, augmented plasma samples, standards and controls the performance and reliability of this assay has been verified." This refers to the independent analytical performance of the kit itself.

7. The type of ground truth used:

• The implicit "ground truth" for assessing the kit's performance would be the known concentrations/presence of metanephrines in the standards, controls, and augmented plasma samples, as determined by reference analytical methods or known spiking concentrations. For clinical correlation, it would relate to the differential diagnosis of pheochromocytoma, but the verification described is about the analytical performance of the assay.

8. The sample size for the training set:

• Not applicable/Not specified. This is an IVD kit, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a kit involves its development and calibration using various samples, but these are not referred to as a "training set" in the context of AI/ML.

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

• Not applicable/Not specified for the reasons stated above.

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Catecholamine test system is a device intended to determine whether a group of similar compounds epinephrine and norepinephrine are present in plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma.

The BAS Plasma Catecholamine Kit employs liquid chromatography with electrochemical detection to separate and quantitate epinephrine (E) and norepinephrine (NE) in human plasma under isocratic conditions as defined in the package insert. BAS provides the mobile phase for the elution of these analytes from the liquid chromatography column, which is also provided, as well as critical reagents for sample preparation. There is one complete start-up kit as well as one accessory replacement kit which will be offered for sale. The accessory replacement kit contains replacement reagents and mobile phase for sample preparation and analysis. The kit is designed for invitro applications only. All reagents and kit supplies contain the appropriate warnings as to irritants, corrosiveness or toxicity, etc. The Plasma Catecholamine Kit is not used in any way to sustain human life or to prevent impairment of human health. Therefore, the kit poses no safety hazard to the patients.

Here's an analysis of the provided text regarding the BAS Plasma Catecholamine Kit, structured to answer your questions about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance Study

The primary study presented aims to demonstrate substantial equivalence of the BAS Plasma Cateamine Kit to a predicate device (Bio-Rad Plasma Catecholamine Kit by HPLC). While explicit "acceptance criteria" in the form of pre-defined thresholds for performance metrics are not clearly stated as such, the study's goal is to show a high correlation and consistency with the predicate device. The correlation coefficient (R value) appears to be a key metric used for this purpose.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "Acceptance Criteria (Implied)" are inferred from the context of substantial equivalence demonstrations, where high correlation and close agreement with a legally marketed device are typically required. The document does not explicitly state numerical thresholds as "acceptance criteria."

2. Sample Size and Data Provenance

• Sample Size for Test Set: 70 samples were used for both Epinephrine and Norepinephrine analysis.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to human plasma samples, but no further details about their collection or demographic information are provided.

3. Number of Experts and their Qualifications for Ground Truth

• This study does not involve human expert interpretation to establish ground truth in the traditional sense of image analysis or diagnostic assessment. The "ground truth" here is effectively the measurement obtained by the predicate device (Bio-Rad Plasma Catecholamine Kit by HPLC).
• Therefore, information about the number or qualifications of experts for ground truth establishment is not applicable to this type of chemical assay comparison.

4. Adjudication Method for the Test Set

• As the "ground truth" is established by the predicate device's measurements, there is no adjudication method involved in the human expert sense. The comparison is directly between the new device's measurements and the predicate device's measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This study is a direct comparison of analytical performance between two in-vitro diagnostic devices, not an assessment of human reader performance or the impact of AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the BAS Plasma Catecholamine Kit's measurements were observed independently. However, its "performance" is implicitly defined by its correlation and agreement with the predicate device, rather than against an absolute, independent gold standard that is distinct from comparison reference. The table provided directly compares the BAS method against the predicate device (CAD) on the same samples.

7. Type of Ground Truth Used

• The "ground truth" in this study is the measurements obtained from the predicate device (Bio-Rad Plasma Catecholamine Kit by HPLC). This is a common approach for demonstrating substantial equivalence for in-vitro diagnostic devices, where an already approved method serves as the reference.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" or "training data" in the context of device development. This is typical for a chemical assay kit comparison, where the device itself is a collection of reagents and a method, rather than a machine learning algorithm that requires training. The 70 samples appear to be for validation/comparison, not for training.

9. How Ground Truth for Training Set was Established

• As no training set is described, this question is not applicable.

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