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Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

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The provided document is a 510(k) premarket notification letter from the FDA regarding "Eon Calcium Reagent." This document is a regulatory approval letter for an in vitro diagnostic (IVD) reagent intended to measure calcium levels in serum and plasma. The information requested (acceptance criteria, study details, sample sizes, ground truth establishment, etc.) is typically found in the scientific documentation submitted as part of the 510(k) application, not in the approval letter itself. Regulatory letters primarily acknowledge substantial equivalence and outline ongoing regulatory responsibilities.

Therefore,Based on the provided FDA 510(k) approval letter (K120626) for the "Eon Calcium Reagent," none of the requested information regarding specific acceptance criteria, device performance tables, study details (sample sizes, provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for either test or training sets is present.

The document is purely an FDA approval letter stating that the device is substantially equivalent to legally marketed predicate devices for the indicated use of measuring total calcium levels in serum and plasma. It does not contain the technical or clinical study data that would detail how the device's performance was evaluated against specific acceptance criteria.

To answer your questions, one would need access to the actual 510(k) submission document, which contains the analytical and clinical performance studies.

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Vital Diagnostics Serum Controls are assayed multi-analyte quality control material. Vital Diagnostics Serum Controls are intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. An assayed quality control material may be used for proficiency testing in inter laboratory surveys.

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This FDA document is a 510(k) clearance letter for a medical device called "Vital Diagnostics Serum Controls." It does not contain any information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI/ML medical devices.

The document states that the device is a quality control material intended to "estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation." This indicates it's a calibrator or control for other diagnostic tests, not a diagnostic device itself that directly analyzes patient data to provide a medical diagnosis.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance with the details you provided (sample size, experts, ground truth, MRMC, standalone performance, training set) because this information is not present in the provided text.

The document mainly covers:

• The 510(k) clearance number (K111063)
• The device name (Vital Diagnostics Serum Controls)
• The regulation number and name (21 CFR § 862.1660, Quality control material)
• Regulatory class (Class I reserved)
• Product codes (JJY)
• The determination of substantial equivalence to predicate devices.
• Indications for Use (as a quality control material).

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The ATAC Serum Calibrator is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens.

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The provided text is related to the FDA's 510(k) premarket notification for the ATAC Serum Calibrator. It outlines the regulatory approval for this device, which is intended for use with ATAC Clinical Systems to establish reference points for various analytes in human specimens.

However, the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement. It is primarily a regulatory approval letter and an "Indications for Use" statement.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about the study from the given input.

To answer your questions, I would need a document that describes the verification and validation studies performed for the ATAC Serum Calibrator, including:

• Specific performance metrics (e.g., accuracy, precision, linearity).
• The acceptance criteria for each metric.
• The results of the studies demonstrating that these criteria were met.
• Details about the study design, sample characteristics, and how ground truth was established.

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The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data.

The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease.

The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.

The Eon 100 is for in vitro diagnostic use only.

The Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma.

I am sorry, but the provided text from the FDA 510(k) summary for the EON 100 Chemistry Analyzer does not contain detailed information regarding the specific acceptance criteria, study design, or the performance data in the format you requested for a software or AI device.

The document primarily focuses on the regulatory clearance for various reagents and the analyzer itself as "substantially equivalent" to legally marketed predicate devices. It lists the indications for use for each component, but it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance or the type of ground truth used.

This type of detailed performance data and study design is typically found in the full 510(k) submission, which is not fully provided here, or in associated scientific publications or clinical study reports. The FDA 510(k) summary is generally a high-level document confirming substantial equivalence based on information submitted by the manufacturer.

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