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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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