(49 days)
The ADVIA IMS® Digoxin method is for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. Measurements obtained are used as an aid in the diagnosis of digoxin overdose and in monitoring therapeutic levels of digoxin to ensure appropriate therapy.
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The Bayer ADVIA IMS® Digoxin assay is intended for in vitro diagnostic use to quantitatively measure digoxin, a cardioactive drug, in human serum. This product is used as an aid in diagnosing digoxin overdose and monitoring therapeutic levels of digoxin for appropriate therapy.
Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. However, the study aims to demonstrate substantial equivalence to the predicate device, the Immuno 1 Digoxin Assay. Therefore, the "reported device performance" is compared directly against the predicate device's performance, implying that performance comparable to or better than the predicate is the de facto acceptance criterion.
| Performance Characteristic | Acceptance Criteria (Implied: Comparable to Immuno 1) | Reported Device Performance (ADVIA IMS) | Predicate Device Performance (Immuno 1) |
|---|---|---|---|
| Imprecision (Total CV%) | Comparable to or better than Immuno 1 | Level 0.75 ng/mL: 6.0% | Level 0.7 ng/mL: 8.2% |
| Level 1.9 ng/mL: 5.9% | Level 2.2 ng/mL: 4.2% | ||
| Level 3.3 ng/mL: 3.8% | Level 3.4 ng/mL: 3.6% | ||
| Correlation (vs. Immuno 1) | Strong correlation (R-value close to 1) | Regression: Y=1.017X+0.055 | N/A (Immuno 1 is the comparison) |
| Low Syx | Syx: 0.265 ng/mL | N/A | |
| R-value close to 1 | R: 0.985 | N/A | |
| Interference (Bilirubin) | % Deviation within acceptable limits (likely |
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.