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510(k) Data Aggregation
(262 days)
The ADVIA® Chemistry Fructosamine (FRUC) Assay For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA® Chemistry systems. Measurement of fructosamine is representative of blood glucose levels over the preceding 2-3 weeks, and is useful for monitoring diabetic patients. ADVIA® Chemistry Fructosamine Calibrator For in vitro diagnostic use in the calibration of the ADVIA® Chemistry Fructosanine (FRUC) assay on ADVIA® Chemistry systems.
The ADVIA® Chemistry Fructosamine reagents are ready-to-use liquid packaged for use on ADVIA® 1650 Chemistry system. The reagents are supplied as 100 tests/wedge, with two (2) wedges in each kit. Reagent 1 (R1) contains Tris Buffer (0.2 mol/L, pH 8.0), Proteinase-K (≥ 1 kU/mL) 4-. Aminoantipyrine (5 mmol/L) and Stabilizers. . Reagent 2 (R2) contains Tris Buffer (0.2 mol/L, pH 8.65), Fructosaminase (≥ 0.5 kU/mL), Peroxidase (horseradish) (0.5 kU/mL) N-ethyl-N-sulphohydroxypropyl-mtoluidine (TOOS) ( 10 mmol/L ) and Stabilizers. The ADVIA® Chemistry Fructosamine Calibrator is a single analyte and single level calibrator. It is lyophilized human serum containing pure fructosamine antigen. There are three (3) vials in each kit. Each vial contains 0.08g. The volume per vial (after reconstitution with deionized water) is 1.0 mL.
Acceptance Criteria and Device Performance Study for ADVIA® Chemistry Fructosamine (FRUC) Assay
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several performance characteristics without explicitly stating pre-defined "acceptance criteria" in a singular table for all performance metrics. However, it indicates that "All of the evaluation studies gave acceptable results when compared to the predicate device" and that the studies "support that the ADVIA® Chemistry Fructosamine Assay... are substantially equivalent to the Diazyme Glycated Serum Protein Assay". Based on the provided data, I will infer the acceptance criteria from the reported performance and the context of substantial equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate/Study Goals) | Reported Device Performance (ADVIA® Chemistry Fructosamine Assay) | Met? |
|---|---|---|---|
| Imprecision (Total CV) | Comparable to predicate device; generally low CV values for clinical assays | Range: 0.8% - 3.5% across various concentrations (39-731 µmol/L) | Yes |
| Linearity/Reportable Range | Deviation from linearity 0.95 or similar) and acceptable regression equation | r = 0.99; Regression: Y = 0.99x - 13.1 µmol/L | Yes |
| Matrix Comparison (Plasma vs. Serum) | High correlation (r > 0.95 or similar) and acceptable regression equation | Lithium Heparin Plasma: r = 0.995; Y = 1.00x + 3.5. Potassium EDTA Plasma: r = 0.994; Y = 1.00x - 4.6 | Yes |
| Analytical Specificity (Interference) | Bias 10% bias at higher, specified levels (e.g., Bilirubin 10 mg/dL, Hemolysis 500 mg/dL, Ascorbic Acid 15 mg/dL). This outcome is typical and implies these are noted as potential interferences, not necessarily a failure to meet acceptance criteria for the intended use given typical clinical concentrations. | Yes (Potential interferences noted for extremely high levels) | |
| Reagent and Calibrator Stability | Stated stability period achieved (e.g., 60 days on system, 12 months shelf life) | Reagent: 60 days on system, 12 months shelf life. Calibrator: 28 days opened, 12 months shelf life. | Yes |
| Traceability/Value Assignment | Traceable to an internal standard, consistent with established protocol | Traceable to an internal standard, value assignment by nested testing protocol. | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- Imprecision: 80 replicates (N=80) for each of 8 samples/controls (total 640 measurements for precision evaluation across various concentrations).
- Linearity/Assay Reportable Range: Assessed by assaying "equally spaced dilutions across the measuring range." The exact number of samples/dilutions used is not specified.
- Limit of Detection (LoD)/Limit of Blank (LoB)/Limit of Quantitation (LoQ): 160 replicates of blank ("zero") serum pool, and several serum pools with fructosamine concentration, with 160 low-level sample replicates for LoD. LoQ based on 160 determinations.
- Method Comparison: 113 human serum samples tested. 3 samples excluded, so 110 samples used for calculations.
- Matrix Comparison: 152 Lithium Heparin plasma samples and 128 Potassium EDTA plasma samples, compared against serum.
- Analytical Specificity (Interference): Not specified per interferent, but implies testing of various interferent levels across different fructosamine sample concentrations.
Data Provenance: The document does not explicitly state the country of origin for the samples (serum pools, human serum/plasma samples). It mentions "human serum or plasma" to be for in vitro diagnostic use. Given Siemens Healthcare Diagnostics, Inc. is in Tarrytown, NY, USA, and the 510(k) submission to the FDA, it is highly probable that the data was collected in the USA. The studies are prospective in nature for the evaluation of the new device's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable for this type of device. The ADVIA® Chemistry Fructosamine Assay is an in vitro diagnostic (IVD) device for quantitative measurement of an analyte (fructosamine) in biological samples. The "ground truth" for such assays is established through:
- Comparison to a legally marketed predicate device (Diazyme Glycated Serum Protein Assay and Randox Fructosamine Calibrator).
- Traceability to internal standards.
- Use of well-defined analytical performance studies (imprecision, linearity, LoD/LoQ, interference, matrix comparison).
There is no mention of human experts establishing ground truth for the test set in the context of clinical interpretation or diagnosis.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret results (e.g., medical images) and their disagreements need to be resolved. This device is a quantitative chemical assay, where measurements are objective and comparisons are made against established analytical methods and statistical metrics, not subjective interpretations requiring 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:
Not applicable. No MRMC study was conducted. This device is an automated chemical analyzer, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance studies described (imprecision, linearity, LoD/LoQ, method comparison, matrix comparison, analytical specificity) are standalone performance evaluations of the ADVIA® Chemistry Fructosamine Assay itself, operating on the ADVIA® 1650 Chemistry system. There is no human interpretation or intervention in the measurement process of the device that would constitute "human-in-the-loop" performance in the context of AI-driven diagnostics. The results are quantitative values generated by the instrument.
7. The Type of Ground Truth Used:
The ground truth for evaluating the ADVIA® Chemistry Fructosamine Assay is primarily established by:
- Comparison to a legally marketed predicate device: "Substantial equivalence was demonstrated by testing several performance characteristics including... method comparison... All of the evaluation studies gave acceptable results when compared to the predicate device."
- Traceability to an internal standard: "The ADVIA Chemistry FRUC assay is traceable to an internal standard."
- Defined analytical methods and accepted statistical models: E.g., CLSI documents EP5-A2, EP17-A2, for precision, detection capability, etc. These methods provide accepted benchmarks for analytical truth.
8. The Sample Size for the Training Set:
Not applicable. This device is an in vitro diagnostic assay, not an AI/machine learning model that typically undergoes a "training set" phase. Its analytical performance is characterized through the studies mentioned earlier, which assess its intrinsic analytical capabilities. The development process would involve formulation, optimization, and internal verification, but not "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable as there is no "training set" for this type of device. The analytical characteristics are validated through comparison to predicate devices, established reference methods, and adherence to performance standards guided by recognized guidelines like CLSI.
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