(181 days)
This in vitro diagnostic method is intended to quantitatively measure the concentration of B2-microglobulin in human serum and urine using the Technicon Immuno 1® system. B2-Microglobulin assay values obtained should be used in conjunction with information available from clinical and other diagnostic procedures in the management of patients with renal dysfunction and rheumatoid arthritis. This diagnostic method is not intended for use on any other system.
This is an in vitro, solid-phase enzyme immunoassay for the quantitative measurement of beta-2-Microglobulin in serum and urine.
The Acceptance Criteria and Study for the Beta-2-Microglobulin Method for Bayer Technicon Immuno 1® System are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a dedicated section. However, it presents performance characteristics of the Immuno 1 beta-2-Microglobulin method and compares them to those of the predicate device (Abbott IMX beta-2-Microglobulin Assay). The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and meeting general performance expectations for such assays.
| Performance Metric | Acceptance Criteria (Implied by Predicate Device/General Expectation) | Reported Device Performance (Immuno 1 beta-2-Microglobulin) | Conclusion |
|---|---|---|---|
| Minimum Detectable Conc. | Comparable to predicate device (Abbott IMX: 0.005 mg/L) | 0.01 mg/L | Deemed acceptable for intended use, though slightly higher than predicate. |
| Precision (Within-Run) | Comparable to predicate device (Abbott IMX: Serum 4.4-6.0%, Urine 4.7-5.5%) | SERUM: 1.79%, 1.25%, 1.89% | |
| URINE: 1.48%, 1.10%, 4.98% | Better than or comparable to predicate device. | ||
| Correlation (Serum) | Strong correlation with predicate device (Abbott IMX) | y=0.99x+0.11, r=0.99, Syx=0.93 mg/L (n=97) | Strong correlation. |
| Correlation (Urine) | Strong correlation with predicate device (Abbott IMX) | y=1.05x-0.05, r=0.99, Syx=0.52 mg/L (n=24) | Strong correlation. |
| Interferences | Beta-2-Microglobulin recoveries within acceptable range (not explicitly defined, but shown in Table 3) | Recoveries for spiked interferants are shown in Table 3. Generally, values are close to the unspiked sample. | Appears acceptable, no significant interferences reported. |
| Sample Dilution | Calculated concentrations should be close to measured concentrations (low deviation %) | Deviations vary but are generally within acceptable limits for a quantitative assay (Tables 4-7, e.g., |
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.