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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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(81 days)
The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures.
The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures. The instrument performs initial sample measurement and pipetting, timed addition of assay reagents, incubation and shaking of assay tubes, aspiration of used reagents and washing of coated polystyrene assay beads and photometric measurement of the chromogen / enzyme reaction.
This document describes the Roche COBAS Core II Immunochemistry System, an in-vitro diagnostic analyzer, and its substantial equivalence to a predicate device. The information provided is primarily focused on the device's technical characteristics and a limited performance comparison, rather than a clinical study evaluating specific diagnostic accuracy or AI performance. Therefore, many of the requested elements for an acceptance criteria and study summary cannot be fully addressed from the given text.
However, based on the provided text, here's an attempt to extract and interpret the information:
Acceptance Criteria and Device Performance Summary:
The acceptance criteria are implied to be precision and correlation similar to the predicate device (COBAS Core I). The reported performance for the COBAS Core II aligns with these implied criteria.
| Acceptance Criteria (Implied) | Reported Device Performance (COBAS Core II) |
|---|---|
| Precision: Within-run and run-to-run reproducibility (CVs) acceptable, comparable to COBAS Core I. | Precision Study: |
- Within-run: Seven times in triplicate for internal reference sera and kit control.
- Run-to-run: Duplicate in 10 independent runs for the same samples.
- Results: Except for one low LH serum, all CVs are "far below 10%".
- Conclusion: "The precision range found for the COBAS Core II correspond to the values determined for the COBAS Core I." |
| Correlation: Strong correlation with the predicate device (COBAS Core I) for patient sample results. | Correlation Study: - Results: For three evaluated assays (LH, FSH, Ferritin), calculated slopes were 1.000 ± 0.014 with a correlation coefficient > 0.995. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Precision Study:
- Four internal reference sera and kit control were tested.
- Within-run: Samples tested seven times in triplicate (implies 21 measurements per sample/control).
- Run-to-run: Samples tested in duplicate in 10 independent runs (implies 20 measurements per sample/control).
- Data Provenance: Not specified, but likely internal lab data given they are "internal reference sera."
- Correlation Study:
- "137 randomly selected clinical samples" were used.
- Data Provenance: Not specified, but "clinical samples" suggests patient samples. Country of origin not mentioned. Retrospective or prospective nature not specified.
- Precision Study:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The concept of "ground truth" as typically used in AI studies (e.g., expert consensus on images or pathology) is not applicable here. This study is an analytical performance validation comparing an instrument's readings to those of a predicate instrument and evaluating its precision, not assessing diagnostic accuracy against an independent gold standard interpreted by experts. -
Adjudication method for the test set:
Not applicable, as this is an analytical performance study, not a diagnostic accuracy study requiring expert adjudication. -
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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is an analytical device validation, not a study involving human readers or AI assistance. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense. The "performance" being evaluated (precision and correlation) is the standalone analytical performance of the COBAS Core II instrument, without human intervention in the result generation process itself, beyond loading samples and controls. However, this is not an "algorithm only" study in the context of AI, but rather an instrument's analytical performance. -
The type of ground truth used:
The "ground truth" in this context is the results obtained from the legally marketed predicate device (COBAS Core I) for the correlation study, and the inherent reproducibility of the measurements for the precision study. -
The sample size for the training set:
Not applicable. This document describes the validation of a new instrument, not the training of an AI algorithm based on a training set. The instrument's operation is based on established immunochemistry principles and pre-programmed software, not machine learning from a training set. -
How the ground truth for the training set was established:
Not applicable for the same reason as point 7.
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