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510(k) Data Aggregation
(123 days)
Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative determination of urea nitrogen in serum, plasma, and urine on Beckman Synchron CX & CX® Delta Analyzers. BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases.
Urea nitrogen concentration is determined by an enzymatic conductivity method employing a Beckman Conductivity Electrode. Electronic circuits determine the rate of increase in conductivity, which is directly proportional to the concentration of BUN in the sample. Mission uses a similar composition, description and packaging as that used by the OEM in its products.
Acceptance Criteria and Device Performance for Mission Diagnostic BUN Reagent
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section. However, the performance characteristics (precision, method comparison, and recovery) are compared against a predicate device, implying that performance similar to or better than the predicate is considered acceptable.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Mission BUN Reagent) |
|---|---|---|
| Precision | CV% within acceptable ranges for clinical applications and comparable to predicate. | Serum Control 1 (13 mg/dL): Total CV = 5.8% |
| Serum Control 2 (48 mg/dL): Total CV = 6.5% | ||
| Urine Control 1 (58 mg/dL): Total CV = 3.3% | ||
| Urine Control 2 (63 mg/dL): Total CV = 4.0% | ||
| Method Comparison (Serum) | Strong correlation ($r^2 \geq 0.99$), linear relationship, and minimal bias compared to predicate. | Equation: Mission = 0.892 x Beckman + 1.22 |
| Range: 4 to 87 mg/dL | ||
| $r^2$: 0.997 | ||
| S(yx): 1.30 mg/dL | ||
| Method Comparison (Urine) | Strong correlation ($r^2 \geq 0.99$), linear relationship, and minimal bias compared to predicate. | Equation: Mission = 0.923 x Beckman + 1.054 |
| Range: 4 to 100 mg/dL | ||
| $r^2$: 0.996 | ||
| S(yx): 1.70 mg/dL | ||
| Recovery to Expected Values (Serum) | Similar average % recovery to predicate across concentration ranges, ideally within 80-120%. | Range: 82 – 106% |
| Overall Mean: 97% | ||
| Recovery to Expected Values (Urine) | Similar average % recovery to predicate across concentration ranges, ideally within 80-120%. | Range: 85.7 – 103.8% |
| Overall Mean: 97.6% | ||
| **Functional Sensitivity (Lowest level with |
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