(24 days)
The Albumin BCG assay is used for the quantitation of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Albumin BCG is an in vitro diagnostic assay for the quantitative determination of albumin in human serum or plasma. The Albumin BCG assay is a clinical chemistry assay in which the analyte in the sample binds specifically to bromcresol green to produce a colored complex. The absorbance at 628 nm of the complex is directly proportional to the albumin concentration in the sample.
The provided 510(k) summary for Abbott Laboratories' "Albumin BCG" assay details the acceptance criteria and the study conducted to demonstrate substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the Albumin BCG assay are based on its performance characteristics, specifically comparison with a legally marketed predicate device (Boehringer Mannheim® Albumin BCG assay on the Hitachi® 717 Analyzer).
| Acceptance Criteria Category | Specific Criteria/Metric | Target/Acceptance Threshold (compared to predicate) | Reported Device Performance (Albumin BCG assay) |
|---|---|---|---|
| Method Comparison | Correlation Coefficient | High (indicating strong linear relationship) | 0.9935 |
| Slope | Close to 1 (indicating proportional agreement) | 0.893 | |
| Y-intercept | Close to 0 (indicating minimal constant bias) | 0.643 g/dL | |
| Precision | Within-run %CV | Low (indicating good repeatability) | Not explicitly stated as a target, but reported as low. |
| Between-run %CV | Low (indicating good intermediate precision) | Not explicitly stated as a target, but reported as low. | |
| Between-day %CV | Low (indicating good reproducibility) | Not explicitly stated as a target, but reported as low. | |
| Total %CV (Level 1/Panel 101) | Low | 0.8% | |
| Total %CV (Level 2/Panel 102) | Low | 0.9% | |
| Linearity | Linear range | Sufficient for clinical use, comparable to predicate | Up to 11.8 g/dL |
| Limit of Quantitation (Sensitivity) | Lower detection limit | Clinically appropriate, comparable to predicate | 0.2 g/dL |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set in the method comparison study. It mentions "Comparative performance studies were conducted," but a specific number of samples or patients is not provided.
The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the context of this 510(k) submission. For in vitro diagnostic assays for quantitative determination of a biomarker, the "ground truth" is typically the measurement obtained from a well-established and validated reference method (in this case, the predicate device). There is no mention of human expert interpretation for establishing ground truth as would be relevant for imaging or diagnostic aid devices.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the "ground truth" is established by the predicate device's performance, not by expert adjudication.
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:
This type of study is not applicable to this device. The Albumin BCG assay is an in vitro diagnostic (IVD) for quantitative measurement of albumin, not an AI-assisted diagnostic device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The Albumin BCG assay is a standalone in vitro diagnostic assay. Its performance is evaluated directly through chemical reaction and measurement, similar to an "algorithm only" in the sense that human interpretation of a visual output is not the primary function being assessed, but rather the accuracy and precision of the quantitative result. The performance characteristics described (correlation coefficient, slope, intercept, precision, linearity, sensitivity) are all measures of the assay's standalone performance.
7. The Type of Ground Truth Used:
The ground truth used for comparison is the performance of a legally marketed predicate device: the Boehringer Mannheim® Albumin BCG assay on the Hitachi® 717 Analyzer. This is a common method for establishing substantial equivalence for IVDs.
8. The Sample Size for the Training Set:
The document does not describe a "training set" in the context of an algorithmic or machine learning device. For IVDs, method development and optimization would occur, which might be analogous to "training," but the data from these phases are not typically referred to as a "training set" in the same way as for AI. The performance studies mentioned are for verification and validation.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as a "training set" in the AI sense is not described. The assay's chemical principles and optimization would have established its "ground truth" for its own development, but this is not detailed in the 510(k) summary. The comparison data relies on the established performance of the predicate device.
§ 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.