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510(k) Data Aggregation
(153 days)
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
The DIGXN method is an in vitro diagnostic test for the quantitative measurement of digoxin in human serum and plasma on the Dimension Vista® System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy.
The DRUG 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) method on the Dimension Vista® System.
Method: The DIGXN method is a homogeneous, sequential, chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated F(ab')2 fragment of an anti-Digoxin mouse monoclonal antibody. The first bead reagent (Chemibeads) is coated with ouabain, a weaker binding analog of digoxin, and contains a photosensitizer dye. In a first step, sample is incubated with biotinylated F(ab')> which allows digoxin from the sample to saturate a fraction of the biotinylated F(ab')2 that is directly related to the digoxin concentration. In a second step, ouabain chemibeads are added and form bead/biotinylated F(ab')> immunocomplexes with the non-saturated fraction of the biotinylated F(ab')>. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemilyminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of the digoxin concentration in the sample.
Calibrator: The DRUG 4 Calibrator is a 5 level, liquid calibrator. It is packaged as a kit of ten vials, two vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is human serum.
Here's a summary of the acceptance criteria and study details for the Dimension Vista® LOCI Digoxin Flex® Reagent Cartridge (K6435) and Dimension Vista® DRUG 4 Calibrator (KC460), based on the provided text:
Acceptance Criteria and Device Performance
| Feature | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (DIGXN vs. Predicate DGNA) |
|---|---|---|
| Method Comparison | ||
| Slope | Close to 1.00 | 1.02 |
| Intercept | Close to 0 ng/mL | -0.04 ng/mL |
| Correlation Coeff. (r) | High, close to 1.0 | 0.98 |
| Reproducibility | (Based on CLSI EP5-A2 guidance and typical precision for similar assays. Specific numerical targets not explicitly stated as "acceptance criteria" but demonstrated through performance.) | |
| Repeatability %CV | Low, indicating good precision | Level 1 QC: 1.5% |
| Level 2 QC: 1.2% | ||
| Level 3 QC: 1.4% | ||
| Level 1 serum pool: 1.5% | ||
| Level 2 serum pool: 1.3% | ||
| Within Lab %CV | Low, indicating good precision | Level 1 QC: 1.7% |
| Level 2 QC: 1.4% | ||
| Level 3 QC: 1.5% | ||
| Level 1 serum pool: 1.7% | ||
| Level 2 serum pool: 1.4% | ||
| Measuring Range |
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