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510(k) Data Aggregation
ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay.
The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several performance characteristics and the results obtained for the ADVIA® 1650 Chemistry Myoglobin Assay. Since this is a submission for substantial equivalence to a predicate device, the "acceptance criteria" are implicitly the performance levels of the predicate device or generally accepted clinical laboratory standards as guided by CLSI documents. The reported performance of the new device is compared to these.
| Performance Characteristic | Acceptance Criteria (Implicit/Guidance) | Reported Device Performance (ADVIA® 1650 Chemistry Myoglobin Assay) |
|---|---|---|
| Precision | As per CLSI EP05-A2 guidance | Within-run SD/CV: 0.70-4.22 SD, 0.5-0.8% CV (depending on sample/concentration) |
| Total SD/CV: 1.41-10.23 SD, 1.8-6.2% CV (depending on sample/concentration) | ||
| Linearity/Assay Reportable Range | Linear range typically defined by predicate device or clinical needs | Linear/measuring range: 22 to 680 ng/mL |
| Limit of Blank (LoB) | As per CLSI EP17-A guidance | 12 ng/mL |
| Limit of Detection (LoD) | As per CLSI EP17-A guidance | 21 ng/mL |
| Limit of Quantitation (LoQ) | As per CLSI EP17-A guidance | 22 ng/mL |
| Method Comparison (Serum) | Good correlation with predicate device (ADVIA Centaur Myoglobin assay) | Correlation coefficient: 0.99 |
| Slope: 0.96 (95% CI: 0.95-0.98) | ||
| Intercept: 12.5 ng/mL (95% CI: 8.3-16.7) | ||
| Range tested: 19.9 - 684.0 ng/mL | ||
| Matrix Comparison (Plasma) | Good correlation with predicate device (ADVIA Centaur Myoglobin assay) | Correlation coefficient: 0.99 |
| Slope: 0.98 (95% CI: 0.96-1.00) | ||
| Intercept: 14.1 ng/mL (95% CI: 8.1-20.1) | ||
| Range tested: 18.9 - 624.1 ng/mL | ||
| Analytical Specificity (Interference) |
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