(142 days)
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (K050596) and the Beta-2 Microglobulin Standard (K050613).
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Quantia Beta-2-Microglobulin reagent was already 510(k) cleared as Quantia Beta-2-Microglobulin for its use with serum and EDTA plasma (K050613). A new submission for the Quantia Beta-2-Microglobulin reagent has been prepared as it is intended to also claim urine as a sample. The kit Quantia Beta-2-Microglobulin already cleared, contained Buffer and Latex Reagent. The Calibrators were already cleared in the submission K050613. There have also been added two different levels of controls in a separate kit. The controls are supplied by Bio-Rad (K851202/A1) and the values are assigned at Biokit S.A. This test with Biokit labeling was cleared K050596.
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1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the Quantia Beta-2 Microglobulin doesn't explicitly state "acceptance criteria" in a typical numerical pass/fail format. Instead, it demonstrates substantial equivalence to a predicate device through various performance characteristics. The table below outlines these performance metrics and the reported results. The implication is that these results were considered acceptable for demonstrating substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison (Urine Samples) | Strong correlation and reasonable agreement with predicate device | Slope: 1.088 |
| Correlation Coefficient (r): 0.9894 (Quantia Beta-2 Microglobulin vs. predicate device over 110 urine samples with B2M levels 0.01 to 18.85 mg/L) | ||
| Within-Run Precision (Urine Samples) | Low Coefficient of Variation (CV) | CV: |
| 4.2% (at mean 0.066 mg/L) | ||
| 1.7% (at mean 0.094 mg/L) | ||
| 1.5% (at mean 0.204 mg/L) | ||
| 1.6% (at mean 0.302 mg/L) | ||
| Linear Range (Urine Samples) | Defined operational range | Automatic Rerun (Dilution Protocol 2): 0.025 to 1.6 mg/L |
| Standard Dilution Protocol: 0.250 to 16 mg/L | ||
| Automatic Rerun (Dilution Protocol 1): 16 to 96 mg/L | ||
| Interference (Urine Samples) | Minimal interference from common substances | Conjugated Bilirubin: No significant interference up to 20.9 mg/dL |
| High Protein Immunoglobulin (IgG): No significant interference up to 100 mg/L | ||
| pH: No positive or negative influence | ||
| Ascorbic Acid: Interference below 10% up to 20 mg/dL | ||
| Hemoglobin: Interference below 10% up to 23.6 mg/dL (Note: Do not use hemolyzed urine) |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 110 urine samples were used for the method comparison study.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
- This information is not provided in the document. The study involves a method comparison against a predicate device, which itself is an already cleared diagnostic for measuring a biochemical marker, Beta-2 Microglobulin. The "ground truth" here is the measurement by the predicate device, not typically established by human experts in this context.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. Adjudication is typically associated with studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies, such as in image analysis or clinical diagnosis studies. For a quantitative assay comparing against a predicate, discrepancies are resolved through analytical comparison statistics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) where the AI assists the human, and the effect size would relate to the improvement in human performance with AI assistance. The Quantia Beta-2 Microglobulin is an in-vitro diagnostic assay for quantitative biochemical measurement, not an AI-assisted interpretation tool for human readers.
6. Standalone (Algorithm Only) Performance Study
- Yes, in essence, the described performance studies are for the standalone performance of the Quantia Beta-2 Microglobulin assay. It measures the Beta-2 Microglobulin concentration without human intervention influencing the measurement result itself (though a human performs the test). The results for method comparison, precision, linear range, and interference are all measures of the device's standalone analytical performance.
7. Type of Ground Truth Used
- The "ground truth" used for the method comparison study was the measurement result obtained from the predicate device, the IL Test Beta-2-Microglobulin, on the same samples. For precision, linear range, and interference studies, the ground truth is derived from established analytical methods and reference values.
8. Sample Size for the Training Set
- This information is not provided or applicable in the traditional sense of a "training set" for machine learning algorithms. The Quantia Beta-2 Microglobulin is a reagent-based immunoturbidimetric assay, not a machine learning model that requires a labeled training set in the same way. Its development would involve analytical characterization and optimization using various samples, but not a distinct "training set" as understood in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
- As noted above, a "training set" in the context of machine learning is not directly applicable here. The development and optimization of such a diagnostic assay would typically involve using samples with known analyte concentrations (established through reference methods or other validated assays) to calibrate the assay, determine reaction kinetics, and establish performance characteristics. This is part of the assay's analytical development process rather than establishing a "ground truth" for a training set in an AI/ML context.
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.