(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 |
§ 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).