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510(k) Data Aggregation
(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.
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(159 days)
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for The Quantitative determination of beta-2-microglubulin concentration in human serum or plasma the ?? Viro quarklative accension in the diagnosis of active rheumatoid arthritis and kidney disease.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510(k) FDA submitted for use with A1-AT) For in vitro diagnostic use
Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.
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 or plasma (EDTA) on the AEROSET® instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia A1-AT reagents by turbidimetry. (NOTE: This control has been also 510 (k) FDA submitted for use with Quantia A1-AT) For in vitro diagnostic use.
Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.
Here's a breakdown of the acceptance criteria and the study details for the Quantia Beta-2 Microglobulin device based on the provided text:
Quantia Beta-2 Microglobulin Acceptance Criteria and Performance Study
This document describes the performance characteristics of the Quantia Beta-2 Microglobulin, a latex particle enhanced immunoturbidimetric assay for the quantitative determination of beta-2-microglobulin in human serum or plasma.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied/Standard for Assay Types) | Reported Device Performance |
|---|---|---|
| Method Comparison | Substantial equivalence to predicate device (implied by 510(k) process and statement) | Slope of 0.876 and correlation coefficient (r) of 0.9986 against predicate device |
| Within-run Precision (CV) | Typically < 5-10% (implied standard for assays) | Control I: 1.1% (at 1.00 mg/L) Control II: 0.9% (at 5.46 mg/L) Third Control: 0.9% (at 13.61 mg/L) |
| Total Precision (CV) | Typically < 10-15% (implied standard for assays) | Control I: 1.9% Control II: 1.3% Third Control: 1.1% |
| Linearity Range (without rerun) | A specified range where results are proportional to concentration (implied) | 0.25 to 16 mg/L |
| Linearity Range (with rerun) | A specified range where results are proportional to concentration (implied) | 0.02 to 100 mg/L |
| Limit of Quantification (without rerun) | Minimum quantity measurable with defined precision and error (CV < 20%, error < ± 20%) | 0.25 mg/L |
| Limit of Quantification (with rerun) | Minimum quantity measurable with defined precision and error (CV < 20%, error < ± 20%) | 0.02 mg/L |
| Interference: Lipemia | No significant interference up to a certain level (implied) | No significant interference up to sample absorbance of 2.1 AU/cm at 660 nm |
| Interference: Triglycerides | No significant interference up to a certain concentration (implied) | No significant interference up to 1300 mg/dL |
| Interference: Bilirubin | No significant interference up to a certain concentration (implied) | No significant interference up to 20 mg/dL |
| Interference: Hemoglobin | No significant interference up to a certain concentration (implied) | No significant interference up to 480 mg/dL |
| Interference: RF | Interference below a certain percentage up to a certain concentration (implied) | Interference below 10% up to 288 IU/mL |
Note: The document directly states the results of the performance studies rather than explicitly listing "acceptance criteria." The acceptance criteria listed above are implied based on common regulatory expectations for in vitro diagnostic devices and the fact that the device received 510(k) clearance, indicating its performance was deemed acceptable for its intended use.
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Method Comparison: 105 serum samples.
- Precision: Not explicitly stated as a "test set" for precision, but control materials were used. Control I, Control II, and a third control (spiked with Beta-2 Microglobulin) were run in duplicate twice a day over twenty days.
- Linearity, Limit of Quantification, Interference: Sample sizes for these specific studies are not explicitly provided in the text beyond the control materials or general statements about the analytes tested.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study was conducted by Biokit S.A. in Spain. Therefore, it is likely the data was generated in Spain or a similar geographical region. The text does not specify if the studies were retrospective or prospective, but assay performance studies are typically prospective evaluations.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is an in vitro diagnostic assay that measures a biomarker concentration. Ground truth is established by the analytical method itself (e.g., accuracy against a reference method or known concentrations) rather than expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is an analytical performance study for an in vitro diagnostic assay, not a study requiring human adjudication of results or interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an analytical performance study for an in vitro diagnostic assay. It does not involve human readers interpreting cases or AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are for the standalone performance of the Quantia Beta-2 Microglobulin assay on the Abbott AEROSET® instrument. There is no human-in-the-loop component mentioned in these performance evaluations.
7. Type of Ground Truth Used
- Method Comparison: The predicate device, IL Test Beta-2-Microglobulin, served as the comparative "ground truth" or reference for evaluating performance equivalence.
- Precision: Ground truth was established by the known concentrations of Beta-2 Microglobulin in the control materials (e.g., purified Beta-2 Microglobulin for spiking, or characterized control levels).
- Linearity, Limit of Quantification, Interference: Ground truth was based on known concentrations of the analyte and interferents, or reference measurements.
8. Sample Size for the Training Set
Not applicable. The Quantia Beta-2 Microglobulin is an immunoturbidimetric assay, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The assay's performance is determined by its chemical and optical reagents and the instrument's calibration and measurement principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this device does not utilize a training set in the context of machine learning. The "ground truth" for calibrating and developing such an assay typically involves using highly purified standards of known concentration and validating methods against established reference procedures.
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