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510(k) Data Aggregation
(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.
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(34 days)
The Albumin BCG assay is used for the quantitation of albumin in human serum. 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 human serum. 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 600 nm of the complex is directly proportional to the albumin concentration in the sample.
The provided text describes a 510(k) submission for the Albumin BCG assay, which is an in vitro diagnostic device. The study described focuses on demonstrating substantial equivalence to a predicate device, rather than a typical clinical efficacy study with acceptance criteria often seen for AI/ML devices. Therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, etc.) is not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|
| Correlation Coefficient (with predicate) | 0.9864 |
| Slope (with predicate) | 0.844 |
| Y-intercept (with predicate) | 0.699 g/dL |
| Total %CV for Level 1/Panel 111 | 2.1% |
| Total %CV for Level 2/Panel 112 | 2.3% |
| Linearity | Up to 7.0 g/dL |
| Limit of Quantitation (Sensitivity) | 0.2 g/dL |
Note: The acceptance criteria themselves are implied by the reported performance figures being deemed "acceptable" and demonstrating "substantial equivalence." No explicit numerical thresholds for acceptance were stated, but the values indicate a high degree of correlation and precision.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "comparative performance studies" and "precision studies" conducted using control material, but does not provide the number of patient samples or the specific sample sizes for these studies.
- Data Provenance: Not explicitly stated. The studies were conducted using the ALCYON™ Analyzer, but the country of origin of the data or whether it was retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is Not Applicable for this type of in vitro diagnostic device 510(k) submission. Ground truth for clinical chemistry assays is typically established through reference methods and internal validation, not through expert consensus in the way imaging or diagnostic AI algorithms might require.
4. Adjudication Method for the Test Set
This is Not Applicable. Clinical chemistry assays do not typically involve adjudication by experts for establishing ground truth; rather, performance is assessed against established measurement principles and reference materials.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is Not Applicable. The device is an in vitro diagnostic assay, not an AI-powered diagnostic system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
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 intrinsically through its chemical reaction and measurement capabilities. Its "performance" refers to the accuracy and precision of its quantitative output, not its ability to interpret complex data that a human might also interpret.
7. The Type of Ground Truth Used
The ground truth for this device's performance assessment is largely established by:
- Predicate Device Comparison: The Boehringer Mannheim® Albumin BCG assay (K81194) on the Hitachi® 717 Analyzer served as the reference standard for comparison, implying its results were considered "ground truth" for demonstrating substantial equivalence.
- Control Material: Precision studies were performed using "two levels of control material," which are laboratory standards with known concentrations, serving as a form of ground truth for evaluating assay variability.
8. The Sample Size for the Training Set
This is Not Applicable. The Albumin BCG assay is a chemical-based in vitro diagnostic method, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying principles are chemical reactions and spectrophotometric measurements.
9. How the Ground Truth for the Training Set was Established
This is Not Applicable for the same reason as above. There is no concept of a "training set" for this type of device.
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