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510(k) Data Aggregation
(474 days)
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The device consists of two reagents: R1 buffer (Tris buffer pH 7.2, polyethylene glycol 6000) and R2 (goat anti-IgG antiserum). The reagents contain sodium azide as preservative.
When a sample is mixed with R1 buffer and R2 antiserum solution, human IqG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates. Immune complexes formed in solution scatter light in proportion to their size, shape, and concentration. Turbidimeters then measure the reduction of incidence light due to reflection, absorption, or scatter. The decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is a result of complexes formed during the antigen-antibody reaction.
The Beckman Coulter Immunoglobulin G (IgG) reagent for quantitative determination of IgG immunoglobulins in human serum, plasma, and cerebrospinal fluid on Beckman Coulter AU/DxC AU analyzers, device K221114, underwent various non-clinical (bench) studies to demonstrate substantial equivalence to its predicate device (K162208).
Here is a summary of the acceptance criteria and reported device performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Sample Type | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|---|
| Method Comparison | Serum | Slope: Not explicitly stated, but R-value of 0.9981 suggests strong correlation. | Slope: 1.015, Intercept: -25.422, R: 0.9981 | Pass |
| CSF | Slope: Not explicitly stated, but R-value of 0.9995 suggests strong correlation. | Slope: 0.998, Intercept: 0.1141, R: 0.9995 | Pass | |
| Linearity/Reportable Range | Serum | Linear Range: 75-3,000 mg/dL Allowable Difference: ±8% between 375-3,000 mg/dL; ±30 mg/dL between 75-375 mg/dL | Linear From: 73.2868 mg/dL Linear To: 3261.9190 mg/dL | Pass |
| CSF | Linear Range: 2-50 mg/dL Allowable Difference: ±10% between 2-50 mg/dL; ±0.5 mg/dL between 2.0-5 mg/dL | Linear From: 1.9 mg/dL Linear To: 53.0 mg/dL | Pass | |
| Sensitivity (LOQ) | Serum | <75 mg/dL at ≤20%CV | 18.5 mg/dL at 10% CV (LOB: 5.6 mg/dL, LOD: 8.6 mg/dL) | Pass |
| CSF | <2 mg/dL at ≤20%CV | 0.63 mg/dL at 20% CV (LOB: 0.11 mg/dL, LOD: 0.31 mg/dL) | Pass | |
| Precision | Serum & Plasma | Within-run Precision: ≤ 3.5% CV Total Precision: < 6% CV | 20-day Precision (CV): Within Run: 0.9% - 3.4% Within Laboratory: 1.2% - 4.9% 5-day Precision (CV): Within Run: 0.8% - 2.8% Within Laboratory: 1.0% - 3.6% Reproducibility: 1.0% - 3.6% | Pass |
| CSF | Within-run Precision: ≤ 6% CV or ≤0.4 mg/dL Total Precision: < 7.5% CV or <0.5mg/dL | 20-day Precision (CV): Within Run: 1.6% - 4.7% Within Laboratory: 2.6% - 5.6% 5-day Precision (CV): Within Run: 0.9% - 1.7% Within Laboratory: 1.4% - 4.4% Reproducibility: 1.4% - 4.7% | Pass | |
| Interference | Serum | Lipemia: Intralipid (1000 mg/dL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL Icteric: Bilirubin (40 mg/dL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL Hemolysis: Hemolysate (500 mg/dL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL RF: RF (1200 IU/mL) interference ≤10% at IgG conc. of 1000 mg/dL & 2000 mg/dL | All interferences found to be ≤10%, indicating no significant interference (NSI). | Pass |
| CSF | Icteric: Bilirubin (36 mg/dL) interference ≤10% at IgG conc. of 5 mg/dL & 20 mg/dL Hemolysis: Hemolysate (500 mg/dL) interference ≤10% at IgG conc. of 5 mg/dL & 20 mg/dL | All interferences found to be ≤10%, indicating no significant interference (NSI). | Pass | |
| Reference Interval | Serum (Adult) | Agreement with original IgG serum reference interval for candidate DxC 500 AU analyzer. Expected Range: 635 - 1,741 mg/dL | The transference study passed, validating the acceptability of the original reference interval (635 - 1,741 mg/dL). | Pass |
2. Sample sizes for the test set and data provenance:
- Method Comparison:
- Serum: 147 samples
- CSF: 114 samples
- Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. The studies were conducted "using patient correlation studies", suggesting human patient samples were used.
- Linearity/Reportable Range: Each dilution was assayed in quadruplicate on a DxC 500 AU analyzer. High and low pools were prepared and inter-diluted. Number of distinct patient samples used for pooling is not specified.
- Sensitivity (LOB, LOD, LOQ):
- LOB: 72 blank replicates per reagent lot (4 blank native serum samples 'analyte-depleted' run n=6 for 3 days).
- LOD and LOQ: 500 replicates per reagent lot for each application (10 low-level samples for IgG run 10-fold for 5 days).
- Precision:
- 20-day study: Not explicitly stated as a number of distinct samples, but samples were tested over 20 days.
- 5-day study: Not explicitly stated as a number of distinct samples, but samples were tested over 5 days.
- Interference: All test samples were assayed n=5 at two analyte levels. The number of distinct samples for each interferent type is not specified.
- Reference Interval: "Transference approach" used to validate the original IgG serum reference interval. The specific number of samples for the transference study is not detailed.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This device is an in vitro diagnostic (IVD) test for quantitative measurement of immunoglobulins. The "ground truth" in this context is the analytically measured concentration of IgG in samples, determined by laboratory methods. Therefore, expert interpretation or consensus as seen in imaging or clinical diagnosis is not directly applicable. The "ground truth" is established by the analytical method itself, calibrated against known standards, and verified through method comparison with predicate devices and established guidelines.
4. Adjudication method for the test set:
Not applicable in the context of quantitative IVD testing. Analytical results are directly compared to predefined acceptance criteria based on industry guidelines (e.g., CLSI).
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. This is an in vitro diagnostic device, not an AI-assisted diagnostic imaging or clinical decision support tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is an analytical reagent system used on automated analyzers. Its performance is inherently "standalone" in the sense that the instrument and reagent determine the quantitative result without human subjective interpretation of the primary measurement. Human involvement lies in sample preparation, loading, and result interpretation, but not in the analytical measurement itself. The studies described are assessing the performance of this standalone analytical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for performance evaluation is based on analytical measurements against established standards and comparison to a legally marketed predicate device. For example:
- Method Comparison: Comparison against the predicate device (Beckman Coulter IgG Reagent on DxC 700 AU analyzer) to demonstrate similar quantitative results.
- Linearity/Sensitivity/Precision: Determined by assessing the device's ability to accurately and reproducibly measure known concentrations or concentrations derived from highly characterized samples.
- Reference Interval: Validation of an existing reference interval for the predicate device, implying that the ground truth for this is derived from previously established clinical studies.
8. The sample size for the training set:
Not applicable. This device is a diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of the reagent and its methods would involve extensive research and development, but this is distinct from "training data" for an AI model.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of this IVD device.
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