(61 days)
System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.
For in vitro diagnostic use.
In this Olympus procedure:
When a sample is mixed with R1 buffer and R2 antiserum solution, human IgA reacts specifically with anti-human IgA 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Olympus IgA Reagent (OSR6X171):
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Olympus IgA (OSR6X171) reagent) |
|---|---|---|
| Precision (Total CV%) | ||
| AU400/400e Sample 1 | As good as or better than 1.53% | 2.43% |
| AU400/400e Sample 2 | As good as or better than 1.63% | 2.52% |
| AU400/400e Sample 3 | As good as or better than 1.26% | 2.95% |
| AU600/640/640e Sample 1 | As good as or better than 1.38% | 3.39% |
| AU600/640/640e Sample 2 | As good as or better than 1.08% | 3.85% |
| AU600/640/640e Sample 3 | As good as or better than 1.81% | 4.01% |
| AU2700/5400 Sample 1 | As good as or better than 2.64% | 1.50% |
| AU2700/5400 Sample 2 | As good as or better than 2.05% | 1.91% |
| AU2700/5400 Sample 3 | As good as or better than 3.29% | 1.83% |
| Assay Range | 10 to 700 mg/dL | 10 to 700 mg/dL |
| LoQ | Not specified (or comparable to predicate) | 10 mg/dL |
| Method Comparison (Linear Regression) | ||
| Intercept | Comparable to 1.3 mg/dL | 15.1 mg/dL |
| Slope | Comparable to 0.957 | 0.923 |
| R^2 | Comparable to 0.99 | 0.999 |
| N | Comparable to 94 | 111 |
| Range | Comparable to 54-660 mg/dL | 38-672 mg/dL |
| Interfering Substances | ||
| Bilirubin (AU400/400e) | Interference |
§ 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).