(384 days)
The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.
The Albumin BCG2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The Albumin BCG2 assay is an automated clinical chemistry assay. The Albumin BCG2 procedure is based on the binding of bromocresol green in the assay reagent specifically with albumin in the patient sample to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.
Methodology: Colorimetric (Bromocresol Green)
The device in question is the Albumin BCG2 assay, used for the quantitation of albumin in human serum or plasma.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance (Albumin BCG2 assay) |
|---|---|---|
| Analytical Measuring Interval | Not explicitly stated, but established by LoQ and ULoQ | 0.3 – 9.4 g/dL |
| Reportable Interval | Not explicitly stated, but extends from LoD to ULoQ | 0.3 – 9.4 g/dL |
| Within-Laboratory Precision | Standard deviations and %CV values demonstrating acceptable precision | Panel 1 (0.4 g/dL): SD 0.00, %CV 0.0 |
| Control Level 2 (2.6 g/dL): SD 0.04, %CV 1.4 | ||
| Control Level 1 (4.1 g/dL): SD 0.06, %CV 1.5 | ||
| Panel 2 (5.7 g/dL): SD 0.06, %CV 1.0 | ||
| Panel 3 (9.4 g/dL): SD 0.07, %CV 0.8 | ||
| Accuracy | Bias within ± 2.4% relative to ERM-DA470k/IFCC | Bias was within ± 2.4% |
| Lower Limits of Measurement (LoB) | Not explicitly stated, but 95th percentile from zero-analyte samples | 0.0 g/dL |
| Lower Limits of Measurement (LoD) | Not explicitly stated, but 95% probability of detection | 0.3 g/dL |
| Lower Limits of Measurement (LoQ) | Maximum allowable precision of 20% CV met | 0.3 g/dL |
| Linearity | Linear across the analytical measuring interval | Linear across 0.3 to 9.4 g/dL |
| Interference | No significant interference (within ± 10%, based on 95% confidence intervals) | No significant interference observed for specified endogenous and exogenous substances |
| Method Comparison (Correlation with Predicate) | High correlation coefficient with the predicate device | Correlation Coefficient: 1.00 (Serum) |
| Intercept: 0.03 | ||
| Slope: 1.03 | ||
| Concentration Range: 0.4 - 8.1 g/dL (Serum) | ||
| Tube Type Suitability | Acceptable for specified blood collection tube types | Serum tubes, Serum separator tubes, Dipotassium EDTA tubes, Lithium heparin tubes, Lithium heparin separator tubes, Sodium heparin tubes |
2. Sample Size Used for the Test Set and Data Provenance
- Within-Laboratory Precision: For each of the 2 controls and 3 human serum panels, 80 replicates were tested (2 duplicates per day for 20 days). The provenance of the human serum panels is not specified (e.g., country of origin, retrospective or prospective).
- Accuracy: The sample size for the accuracy study is not specified, but it involved determining bias relative to a standard reference material.
- Lower Limits of Measurement: For LoB, LoD, and LoQ, n ≥ 60 replicates of zero-analyte (LoB) or low-analyte (LoD, LoQ) samples were used.
- Linearity: The sample size for the linearity study is not explicitly stated.
- Potentially Interfering Substances: The sample size for this study is not explicitly stated.
- Method Comparison: 128 serum samples were used. The provenance of these samples is not specified.
- Tube Type: Samples were collected from a minimum of 40 donors. The provenance of these samples is not specified.
The studies described are non-clinical laboratory studies, suggesting they were conducted in a controlled lab setting rather than directly on patient data in a clinical environment. Whether the data is retrospective or prospective is not explicitly stated, but the nature of the studies (e.g., precision, linearity) typically involves prospective experimental designs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the Albumin BCG2 assay studies described. This device is an in vitro diagnostic (IVD) quantitative assay, and its performance is evaluated against analytical benchmarks, reference materials, or a predicate device, not by expert interpretation of images or clinical outcomes that require a ground truth established by human experts.
4. Adjudication Method
Not applicable for this type of IVD device and studies. Performance is measured using quantitative analytical methods, not involving human adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a quantitative laboratory assay, not an imaging device or AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. Standalone Performance Study
Yes, the studies described are standalone performance studies of the Albumin BCG2 assay. The results reflect the algorithm/device's analytical performance (precision, accuracy, linearity, etc.) without human intervention in the result generation or interpretation to arrive at the reported quantitative values. The "human-in-the-loop" for this type of device typically refers to standard laboratory procedures for running samples and interpreting flagged results, which is inherent to its use but not a part of the core performance metrics discussed here.
7. Type of Ground Truth Used
- Accuracy: The ground truth for accuracy was established using a standard reference material: European Reference Materials Standard Reference Material - DA470k/ International Federation of Clinical Chemistry and Laboratory Medicine (ERM - DA470k/IFCC).
- Method Comparison: The predicate device, Albumin BCG (K981758; List No. 7D53), served as the reference for comparison, effectively acting as a "ground truth" or established method against which the new device's measurements were assessed for agreement.
- For other analytical performance characteristics (precision, linearity, limits of measurement, interference), the "ground truth" is understood as the expected or known concentrations in spiked samples, controls, or reference materials, or ideal analytical behavior.
8. Sample Size for the Training Set
Not applicable. This document describes a traditional in vitro diagnostic device, not one utilizing machine learning or artificial intelligence that would typically involve a "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for this 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.