(101 days)
This Magnesium procedure is invitro Diagnostic use in the automated, quantitative determination of Magnesium in serum. Magnesium measurements are use in the diagnostics and treatment of hypomagnesemia (abnormally low levels of serum magnesium) and hypermagnesimia (abnormally high levels of serum magnesium).
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Unfortunately, the provided text does not contain the specific information needed to answer your request. The document is a 510(k) clearance letter from the FDA for a "Magnesium" diagnostic device, indicating its substantial equivalence to a predicate device for the in vitro quantitative determination of magnesium in serum.
However, it does not provide details about:
- Acceptance criteria and reported device performance: This letter confirms clearance, but doesn't detail the performance metrics.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for the test set. These are typically found in the summary of safety and effectiveness, clinical study reports, or validation documents, which are not included here.
- Sample size for the training set or how its ground truth was established. This information is also absent from the provided FDA clearance letter.
To answer your questions, you would need access to the actual 510(k) submission, specifically the sections dealing with device performance studies and validation.
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.