(183 days)
The Quantikine IVD β,-microglobulin EIA kit is intended for the quantitative determination of β, microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.
The product is a competitive binding enzyme immunoassay (EIA) for ß2 microglobulin.
The provided text describes the acceptance criteria and performance of the Quantikine™ IVD™ ß2 microglobulin enzyme immunoassay.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Signal generated by standard 0 to be greater than 1.5 absorbance units | Not explicitly stated, but implied to be met for device approval. |
| Signal generated by standard 5 to be less than 0.35 absorbance units | Not explicitly stated, but implied to be met for device approval. |
| Curve fitting individual replicates of Standard 1 to fit within ±15% of nominal value and the Mean value of Standard 1 to fit within ±10% of nominal value. Individual replicates and Mean values of Standards 2-5 to fit within ± 10% of nominal value. | Not explicitly stated, but implied to be met for device approval. |
| In-house control and kit control values to be within the ranges quoted on the appropriate control data sheets. | Not explicitly stated, but implied to be met for device approval. |
| Sensitivity to be less than 0.2 µg/mL. | ** |
§ 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.