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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 <20% CV) | Comparable to or better than predicate device. | Mission reagent: 3 mg/dL |
| Beckman reagent: 5 mg/dL |
2. Sample Size and Data Provenance:
- Precision:
- Sample Size: For each of the 4 controls (2 serum, 2 urine), 'N' = 80 observations. This was obtained by running samples for 20 days, 2 runs per day, and 2 observations per run (20 * 2 * 2 = 80).
- Data Provenance: Not explicitly stated, but based on the context of a new reagent being tested against a predicate, it is likely a prospective study conducted by Mission Diagnostics. No country of origin is specified.
- Method Comparison:
- Serum: 'n' = 66 individual observations (derived from spiked/diluted samples run in triplicate).
- Urine: 'n' = 40 individual observations (derived from spiked/diluted samples run in triplicate).
- Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics. No country of origin is specified.
- Recovery to Expected Values:
- Serum & Urine: Specific 'n' for individual recovery experiments not given, but refers to "Pooled Serum" and "Urine recovery samples" which were diluted and measured.
- Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics.
- Functional Sensitivity:
- Sample Size: For each dilution, 'N' = 20 (4 samples per run over 5 calibrated runs).
- Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a diagnostic reagent for quantitative measurement of BUN, not an imaging or qualitative diagnostic device that requires expert interpretation for ground truth. The "ground truth" for the test set is established by the reference measurement from the predicate device and expected values from spiked/diluted samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No expert adjudication was involved as this is a quantitative chemical assay.
5. 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:
Not applicable. This is a chemical reagent, not an AI or imaging diagnostic device that relies on human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This study directly reports the "standalone" performance of the Mission BUN Reagent as a chemical assay. The performance is assessed against a predicate device rather than an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for this study is based on:
- Reference measurements from the predicate device (Beckman BUN Reagent): Used for method comparison studies.
- Expected values from gravimetrically spiked or diluted samples: Used for recovery studies.
8. The sample size for the training set:
Not applicable. This is a chemical reagent, not an AI or machine learning model that requires a training set. The "training" for the device, if any, would be the calibration process of the Beckman Synchron CX & CX® Delta Systems according to manufacturer instructions.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
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