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510(k) Data Aggregation
(73 days)
N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.
The proposed product, N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine.
In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
The N Antiserum to Human Albumin underwent studies to demonstrate its performance, specifically focusing on its correlation with a legally marketed predicate device and its precision.
1. Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Correlation | Not explicitly stated, but typically a high correlation coefficient (e.g., >0.95) with the predicate device is sought for quantitative assays. | Correlation Coefficient (r): 0.99 (with Beckman micro Albumin (MA) Reagent) |
| Y-intercept: -0.73 | ||
| Slope: 1.12 | ||
| Intra-assay Precision (%CV) | Not explicitly stated, but typically low %CV values are desired for good precision (e.g., <10% for clinical assays). | 2.21 to 3.94% |
| Inter-assay Precision (%CV) | Not explicitly stated, but typically low %CV values are desired for good precision (e.g., <10% for clinical assays). | 1.77 to 5.01% |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Correlation Study: 79 urine samples were used for the comparative study measuring albumin.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The ground truth for this device's performance assessment appears to be based on comparative measurements against a predicate device and internal precision studies, rather than expert consensus on diagnostic images or clinical interpretations.
4. Adjudication Method for Test Set
- Not applicable. As noted above, the assessment of performance is based on quantitative measurements and statistical analysis, not expert adjudication of diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is an in vitro diagnostic reagent, not a device that involves human readers interpreting diagnostic data.
6. Standalone Performance Study
- Yes, a standalone performance study was done for precision. The N Antiserum to Human Albumin was evaluated for intra-assay and inter-assay precision on the Behring Nephelometer. This demonstrates the algorithm's (or in this case, the reagent's analytical method's) inherent performance characteristics.
- The correlation study also assessed the standalone performance by comparing its results directly to a predicate device, effectively showing its performance in measuring albumin.
7. Type of Ground Truth Used
- For the correlation study: The "ground truth" was established by the measurements obtained from the predicate device, the Beckman micro Albumin (MA) Reagent. The assumption is that the predicate device provides accurate measurements of albumin.
- For the precision studies: The "ground truth" is the inherent variability of the assay itself under repeat measurements, assessed using statistical methods (%CV). There isn't an external "ground truth" in the same sense as pathology for an imaging device.
8. Sample Size for Training Set
- Not applicable. This is an in vitro diagnostic reagent, not an AI/ML algorithm that requires a training set of data. The performance is based on the chemical and immunological properties of the reagent and the measurement capabilities of the nephelometer system.
9. How Ground Truth for Training Set Was Established
- Not applicable, as no training set was used for this type of device.
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