Search Results
Found 2 results
510(k) Data Aggregation
(149 days)
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 < allowable nonlinearity). | Linear from 0.2 mg/dL to 8.0 mg/dL. Reportable range confirmed as 0.3 - 8.0 mg/dL. |
| Limit of Detection (LoD) | Reliably detect the smallest amount of analyte (LoD) and quantify at a specified CV (LoQ). | LoD: 0.25 mg/L, LoQ: 0.30 mg/L |
| Analytical Specificity / Interference | No significant interference (within +/- 10% of control result) at specified concentrations of interfering substances. | No significant interference found for: - Hemoglobin up to 1000 mg/dL - Conjugated Bilirubin up to 40 mg/dL - Unconjugated Bilirubin up to 40 mg/dL - Ascorbic Acid up to 3000 µg/dL - Intralipid up to 1000 mg/dL (or 3000 mg/dL simulated triglycerides) |
| Method Comparison (vs. Predicate) | Substantially comparable with the predicate device. | Slope: 0.981, Intercept: 0.00 mg/dL, Correlation: 0.9848 |
| Matrix Comparison (Serum vs. Plasma) | Substantially comparable between serum and Li Heparin plasma. | Slope: 1.009, Intercept: -0.12 mg/dL, Correlation: 0.9903 |
| Expected Values / Reference Range | Literature reports of adult reference ranges for magnesium are supported by a study with no outliers. | Reference range supported by a study of 20 healthy donors with no outliers. |
Study Details
-
Sample size used for the test set and the data provenance:
- Precision: Not explicitly stated as a test set size for a single study, but samples (serum pools and control materials) were tested twice per day in duplicate for 20 days.
- Linearity: 11 concentrations of magnesium (dilutions of a high concentration serum pool).
- Detection Limit: 60 replicates of a zero magnesium sample and 60 replicates of a low concentration serum control (total 120 replicates).
- Analytical Specificity: Three samples of human serum at different magnesium concentrations were tested in quadruplicate for each interfering substance.
- Method Comparison: 100 serum samples.
- Matrix Comparison: Not explicitly stated as a number, but refers to "fresh samples from non-fasting donors."
- Reference Range Validation: 20 serum samples from apparently healthy donors.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they use acquired samples.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement. The "ground truth" for analytical performance tests (precision, linearity, detection limits, specificity, method comparison) relies on established reference methods, spiked samples, or known concentrations, rather than expert consensus on diagnostic images or interpretations.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement. Adjudication methods are typically used for qualitative or interpretive assessments (e.g., in imaging studies) where human disagreement needs resolution.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiology AI), not for a quantitative chemical assay.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics described (precision, linearity, detection limit, analytical specificity) are standalone performance of the assay itself on an automated chemistry analyzer (Roche/Hitachi 717). The method comparison and matrix comparison also evaluate the device's performance against a predicate or different matrix, not human readers.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Precision: Internal controls and serum pools with target values.
- Linearity: Serially diluted samples from a high concentration pool, where relative concentrations are known.
- Detection Limit: Zero magnesium samples and low concentration serum control samples.
- Analytical Specificity: Spiked samples with known concentrations of interfering substances, compared to unspiked controls.
- Method Comparison: Comparison against the predicate device (Beckman Coulter Magnesium Reagent, K944407)
- Matrix Comparison: Comparison between the candidate device run on serum vs. plasma samples.
- Reference Range: Samples from "apparently healthy donors" (implying clinically normal magnesium levels).
-
The sample size for the training set:
- Not applicable. This device is a chemical reagent and does not involve machine learning or AI that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and assay optimization.
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
Ask a specific question about this device
(88 days)
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.
Ask a specific question about this device
Page 1 of 1