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510(k) Data Aggregation
(149 days)
MAGNESIUM ASSAY
The Sekisui Magnesium Assay is for the quantitative determination of magnesium in human serum and plasma (Lithium Heparin) on automated chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.
The Sekisui Magnesium assay kit consists of the following: Magnesium Reagent: A solution containing buffer (pH 11.2 at 25°C), 0.14 mmol/L xylidy/ blue-1, 0.1 mmol/L EGTÅ, and a surfactant.
Here's a breakdown of the acceptance criteria and the study information for the Sekisui Magnesium Assay, based on the provided text:
Acceptance Criteria and Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance (Sekisui Magnesium Assay) |
|---|---|---|
| Precision | Total CV%: | |
| 0.8 mg/dL (low) | N/A (evaluated per CLSI EP5-A2) | 6.1% |
| 2.0 mg/dL (mid) | N/A (evaluated per CLSI EP5-A2) | 3.7% |
| 4.7 mg/dL (high) | N/A (evaluated per CLSI EP5-A2) | 3.2% |
| Within Run CV%: | ||
| 0.9 mg/dL (low) | N/A (evaluated per CLSI EP5-A2) | 7.0% |
| 2.0 mg/dL (mid) | N/A (evaluated per CLSI EP5-A2) | 2.2% |
| 4.9 mg/dL (high) | N/A (evaluated per CLSI EP5-A2) | 1.6% |
| Linearity / Reportable Range | Demonstrably linear over the specified range for a linear equation (Nonlinearity |
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(88 days)
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.
The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the callbration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.
Not Found
The provided text is a 510(k) premarket notification acceptance letter from the FDA for a Magnesium Assay (XB) device. It confirms the device's substantial equivalence to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.
The information requested in your prompt (e.g., acceptance criteria table, sample sizes, ground truth establishment, MRMC studies) is typically found in the technical documentation submitted by the manufacturer as part of the 510(k) application, not in the FDA's acceptance letter itself.
Therefore, I cannot fulfill your request with the provided input. The document mainly states that the device was reviewed and found substantially equivalent, but it doesn't elaborate on how that determination was made in terms of specific performance data and criteria.
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