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510(k) Data Aggregation
(61 days)
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers.
The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.
In this Olympus procedure:
When a sample is mixed with R1 buffer and R2 antiserum solution, human IgG 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 measure the reduction of incidence light due to reflection, absorption or scatter.
In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.
The provided document is a 510(k) summary for a medical device called "Olympus IgG Reagent (OSR6X172)". This is an in vitro diagnostic device, specifically a reagent used for quantitative determination of IgG immunoglobulins. The acceptance criteria and supporting studies are presented by comparing the new device's performance characteristics with those of predicate devices already on the market.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an in vitro diagnostic reagent rather than an imaging or AI-driven diagnostic device, the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or AUC, but rather in terms of demonstrating substantial equivalence to predicate devices through various performance characteristics. The acceptance criterion is generally that the new device's performance characteristics (e.g., precision, assay range, method comparison) are comparable to or better than the predicate's, and suitable for its intended use.
Here's a table summarizing the reported device performance and comparison to predicate devices, acting as de-facto acceptance criteria for substantial equivalence:
Serum/Plasma Applications
| Characteristic | Acceptance Criteria (Predicate) | Olympus IgG (OSR6X172) Performance (New Device) | Status |
|---|---|---|---|
| Intended Use | Quantitative determination of IgG immunoglobulins in human serum on OLYMPUS analyzers. | Quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. | Meets/Exceeds |
| Measurement | Quantitative | Quantitative | Meets |
| Instrument Required | Olympus AU400/400e, 600/640/640e and 2700/5400 | Same | Meets |
| Reagent Handling | Ready for use | Ready for use | Meets |
| Methodology | Immunoturbidimetric | Same | Meets |
| Reagent Storage Form | Liquid, On-board storage | Same | Meets |
| Calibration | Olympus Serum Protein Multi-Calibrator (ODR3021) | Same | Meets |
| Calibration Traceability | Traceable to CRM 470 (RPPHS lot 91/0619) | Same | Meets |
| Antibody | Goat Anti-IgG antiserum | Same | Meets |
| Expected Values | 635-1741 mg/dL | Same | Meets |
| Reagent On-Board Stability | 90 days when stored refrigerated on analyzer. | Same | Meets |
| Calibration Frequency | 90 days | Same | Meets |
| Assay Range | 75-3000 mg/dL | 75-3000 mg/dL (same) | Meets |
| Specimen Type | Serum | Serum, Li-heparin or EDTA plasma, and cerebrospinal fluid | Exceeds (New CSF app. included) |
| LoQ | Not specified | 75 mg/dL | Specified/Meets |
| Prozone Capacity | Not specified | No high dose effect at IgG concentrations up to 30,000 mg/dL (Much higher than typical physiological range, demonstrating robustness) | Exceeds |
| Precision (Total CV%) | AU400/400e: Samples 1,2,3 (0.82, 1.06, 2.24); AU600: Samples 1,2,3 (2.50, 1.54, 1.92); AU640/640e: Samples 1,2 (1.00, 1.00); AU2700/5400: Samples 1,2,3 (1.54, 2.39, 2.84) | AU400/400e: Samples 1,2,3 (2.18, 2.29, 3.43); AU600/640/640e: Samples 1,2,3 (3.29, 3.49, 4.66); AU2700/5400: Samples 1,2,3 (1.51, 1.87, 2.03) (Comparably low CVs, indicating good precision, generally within acceptable lab limits for immunoassays) | Meets |
| Method Comparison (Linear Regression) | Intercept: -117, Slope: 1.086, R2: 0.993, n: 98, Range: 223-2633 mg/dL | Intercept: 37.2, Slope: 0.945, R2: 0.998, n: 120, Range: 195-2986 mg/dL (R^2 > 0.99 indicates excellent correlation) | Meets |
| Interfering Substances | Bilirubin (AU400/400e: <1% up to 40 mg/dL); Hemolysis (AU400/400e: <2% up to 500 mg/dL); Lipemia (AU400/400e: <10% up to 1000 mg/dL); RF (Not Specified); Ascorbic Acid (AU400/400e: <1% up to 20 mg/dL) | Bilirubin (AU400/400e: <2% up to 40 mg/dL); Hemolysate (AU400/400e: <3% up to 500 mg/dL); Lipemia (AU400/400e: <3% up to 1000 mg/dL); RF (<7% up to 1200 IU/mL) (Comparable or improved interference tolerance) | Meets/Exceeds |
CSF Application
| Characteristic | Acceptance Criteria (Predicate) | Olympus IgG (OSR6X172) Performance (New Device) | Status |
|---|---|---|---|
| Intended Use | Quantitative determination of IgG in human serum, plasma and cerebrospinal on Roche/Hitachi Cobas c systems. | Quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers. | Meets |
| Measurement | Quantitative | Same | Meets |
| Specimen Type | Serum, plasma, and cerebrospinal fluid | Same | Meets |
| Antibody | Goat Anti-IgG antiserum | Same | Meets |
| Instrument Required | Roche/Hitachi Cobas c systems. | Olympus AU400/400°, 600/640/640° and 2700/5400 | Different but specific |
| Expected Values | 1-3 mg/dL | 15 – 20 y 3.5 mg/dL ± 2.0 mg/dL. 21 – 40 y 4.2 mg/dL ± 1.4 mg/dL. 41 – 60 y 4.7 mg/dL ± 1.0 mg/dL (Different value range, but provided with context of age, indicating physiological relevance) | Meets |
| Reagent On-Board Stability | 84 days when stored refrigerated. | 90 days when stored refrigerated in compartment of the analyzer. | Exceeds |
| Assay Range | 0.4-20 mg/dL | 2-50 mg/dL (Wider range for the new device) | Exceeds |
| LoQ | Not specified | 2 mg/dL | Specified/Meets |
| Prozone Capacity | No high dose effect at IgG concentrations up to 100 mg/dL | No high dose effect at IgG concentrations up to 6,000 mg/dL (Significantly higher, indicating better robustness) | Exceeds |
| Precision (Total CV%) | Samples 1,2: (2.1, 1.1) | AU400/400e: Samples 1,2,3 (9.82, 4.08, 3.61); AU600/640/640e: Samples 1,2,3 (9.53, 3.67, 2.81); AU2700/5400: Samples 1,2,3 (10.24, 6.29, 3.83) (Comparably low CVs, indicating good precision, generally within acceptable lab limits for immunoassays) | Meets |
| Method Comparison (Linear Regression) | Intercept: -0.17, Slope: 0.997, R2: 1.000, Range: 1.07-18.6 mg/dL | Intercept: -0.069, Slope: 1.067, R2: 0.998, Range: 2.0-42.9 mg/dL (R^2 > 0.99 indicates excellent correlation) | Meets |
| Interfering Substances | Bilirubin (<10% up to 15 mg/dL); Hemolysis (<10% up to 200 mg/dL) | Bilirubin (<10% up to 36 mg/dL); Hemolysis (<10% up to 500 mg/dL) (Improved interference tolerance) | Exceeds |
2. Sample Sizes Used for the Test Set and Data Provenance
- Serum/Plasma Method Comparison:
- Sample Size (n): 120 samples for the new device study. The predicate had n=98.
- Data Provenance: Not explicitly stated (e.g., country of origin). However, given the context of a 510(k) submission for the US market, it's typically assumed to be relevant clinical samples, likely from a US-based or similar regulated environment unless specified otherwise. No indication of retrospective or prospective.
- CSF Method Comparison:
- Sample Size (n): Not explicitly stated numbers for the new device in the table for CSF, but linear regression data is provided. The predicate's study data (R2=1.000) shows a range of 1.07-18.6 mg/dL indicative of using patient samples, but the 'n' is not mentioned.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
- Precision: 3 samples (levels) were tested for each instrument platform (AU400/400e, AU600/640/640e, AU2700/5400) for both serum/plasma and CSF applications. These would typically be control materials or pooled patient samples.
- Interfering Substances: Testing was conducted at specific concentrations of bilirubin, hemolysate, lipemia, and RF (for serum/plasma) or bilirubin and hemolysis (for CSF). The number of individual samples tested at these concentrations is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the performance of an in vitro diagnostic reagent measuring a biochemical analyte (IgG). "Ground truth" in this context refers to the true concentration of IgG in the samples, which would usually be established by a reference method or a highly accurate, often predicate, measurement system. Expert consensus or interpretation (e.g., radiologists) is not applicable here. The "ground truth" for the method comparison studies is the result obtained from the predicate device or a recognized reference method.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is for an in vitro diagnostic reagent, not a diagnostic imaging or AI-driven device requiring human adjudication of results. The performance is assessed by comparing quantitative results to a predicate device's results.
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 reagent, not an AI-assisted diagnostic device, and therefore does not involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a standalone diagnostic test in the sense that it performs a quantitative measurement on a biochemical analyzer without direct human interpretation of a complex output. The tables provided illustrate the performance of the reagent on various Olympus AU analyzers. This data directly represents the "algorithm only" performance (i.e., the reagent's performance on the specified instruments).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the test set (method comparison) was obtained by running the same patient samples on the predicate device(s).
- For Serum/Plasma, the predicate was "Olympus (OSR6145) IgG Reagent".
- For CSF, the predicate was "Roche Tina-Quant IgG GEN.2".
The precision and interference studies use contrived samples (e.g., spiked samples, control materials) where the "true" value or concentration is known or independently verified.
8. The Sample Size for the Training Set
Not applicable in the conventional sense of machine learning. This is a biochemical reagent, not a machine learning model. The "development" or "optimization" of the reagent would involve chemical formulation and analytical testing, not a "training set" in the AI context.
9. How the Ground Truth for the Training Set Was Established
Not applicable for a biochemical reagent. The formulation and performance characteristics of the reagent are established through standard chemical and biological assay development and validation practices.
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