(66 days)
Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.
Total Immunoglobulin E (IGE) reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and IGE Calibrator, is intended for the quantitative determination of total human immunoglobulin E (IgE) in serum or plasma by rate turbidimetry.
The presented document is a 510(k) summary for the IMMAGE® Immunochemistry System Total Immunoglobulin E (IGE) Reagent and Calibrator, submitted by Beckman Coulter, Inc. It describes the device, its intended use, comparison to a predicate device, and a summary of performance data.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for slope, intercept, r-value, or imprecision percentages. Instead, it presents the results of method comparison and imprecision studies as evidence of substantial equivalence to the predicate device. The implied acceptance is that the device's performance is comparable to or within expected variations for such assays, as demonstrated by the presented data.
| Study Type | Metric | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|---|
| Method Comparison | Slope | Close to 1.0 | 1.06 | Indicates good correlation between the IMMAGE system and the predicate Access Total IgE system. |
| Intercept | Close to 0 | 2.75 | A small intercept indicates minimal systematic bias. | |
| r (correlation coefficient) | High (e.g., >0.95) | 0.991 | Demonstrates strong linear correlation with the predicate method. | |
| n (sample size) | Adequacy for statistical significance | 125 | Generally considered a reasonable sample size for method comparison in diagnostic assays. | |
| Imprecision | %CV (Within-Run) | |||
| Level 1 | Low (e.g., typically |
§ 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).