(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: 0.99 indicates excellent correlation) | Meets | |
| Interfering Substances | Bilirubin ( |
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).