(61 days)
The Albumin BCP is used for the quantitation of albumin in human serum or plasma. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.
Albumin BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum or plasma. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to a bromocresol purple dye in acidic media to form a colored complex. The absorbance of the albumin chromophore complex is measured at 604 nm and is directly proportional to the concentration of albumin present in the sample.
Here's a breakdown of the acceptance criteria and study details for the Albumin BCP device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similar clinical results to predicate device | Achieved. The study aimed to demonstrate substantial equivalence to the Boehringer Mannheim Albumin BCP assay (K844426) on the Hitachi 717 Analyzer. |
| Method Comparison (Correlation) | Acceptable correlation with predicate device | Correlation coefficient = 0.9914, slope = 1.056, and Y-intercept = - 0.001 g/dL. (These metrics are generally accepted as indicating strong correlation in clinical chemistry method comparison studies when the correlation coefficient is close to 1, the slope is close to 1, and the y-intercept is close to 0) |
| Precision | Acceptable within-run, between-run, and between-day studies for two levels of control material | Total %CV for Level 1/Panel 101 is 0.8% and Level 2/Panel 102 is 0.8%. (These CVs are very low, indicating high precision.) |
| Linearity | Linear range of measurement | Linear up to 13.1 g/dL. |
| Limit of Quantitation (Sensitivity) | Defined minimum quantifiable concentration | 0.05 g/dL. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the sample size used for the comparative performance studies (method comparison, precision, linearity, and sensitivity). It mentions "two levels of control material" for precision studies, but not the number of individual samples or patient samples.
- Data Provenance: Not explicitly stated. The document refers to "human serum or plasma" for the intended use and "comparative performance studies," implying that the data would be based on human samples. However, the country of origin or whether the data was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is an in vitro diagnostic assay that measures a quantitative biomarker (albumin). The "ground truth" for such devices is established through established analytical methods and reference standards, not typically through human expert adjudication as would be the case for image-based diagnostic aids. The performance is assessed against the results of a predicate device (Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer) as the comparative standard.
4. Adjudication Method for the Test Set:
- Not applicable. See explanation above. The comparison is analytical, not based on human judgment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not relevant for this type of in vitro diagnostic device. MRMC studies are typically performed for devices that assist human readers (e.g., radiologists, pathologists) in interpreting medical images or complex data. The Albumin BCP assay provides a direct quantitative measurement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes. The performance characteristics presented (correlation, precision, linearity, sensitivity) describe the standalone performance of the Albumin BCP assay itself when run on the AEROSET™ System. There is no human intervention in interpreting the output of this quantitative assay; the result is a numerical value.
7. Type of Ground Truth Used:
- Reference Method/Predicate Device Comparison: The "ground truth" or reference for evaluating this new device's performance was the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices.
- Established Analytical Principles: The linearity and sensitivity are determined based on the assay's ability to accurately measure known concentrations or detect low levels of albumin, respectively. Precision is measured by the reproducibility of results for control materials with known concentrations.
8. Sample Size for the Training Set:
- Not applicable. The Albumin BCP assay is a chemical assay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a device would involve optimizing the chemical reagents and instrument parameters during its development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As it's not a machine learning model, a training set and its associated ground truth are not relevant concepts. The developmental process would rely on chemical principles and laboratory testing to ensure the assay reagents and methodology produce accurate and reliable quantitative results.
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.