Quantikine(Tm) Erythropoietin/Enz Link Immun Assay
by R&D Systems, Inc. 510(k)
Active
510(k) K931666
Overview
The Quantikine Erythropoietin Enzyme-Linked Immunoassay is a diagnostic in vitro device designed for the quantitative measurement of erythropoietin (EPO) levels in biological samples. Classified as an immunoassay, it employs enzyme-linked technology to detect and quantify EPO concentrations, aiding in the assessment of hematologic conditions and renal function.
This assay is supplied as a ready-to-use kit, intended for laboratory use only. It is classified as a Class II device under FDA 510(k) clearance (K931666) and falls under the product code GGT for erythropoietin assays. The device is not described as sterile or single-use in the provided data, and no MRI safety or storage specifications are noted. Authorized for use in hematology applications, it adheres to regulatory standards outlined in 21 CFR 864.7250.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931666 | Date20 Jul 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GGT
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7250
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from R&D Systems, Inc.
Questions
What clinical applications is this assay primarily used for in a laboratory setting?
This assay is designed for quantitative measurement of erythropoietin (EPO) levels in biological samples, which aids in evaluating hematologic conditions and assessing renal function. Since it is classified under the product code GGT for erythropoietin assays and authorized for hematology applications, it is particularly useful for diagnosing or monitoring disorders related to red blood cell production or kidney function.
Is this device intended for single-use or can it be reused in a clinical laboratory?
The provided data does not explicitly state whether the Quantikine Erythropoietin Enzyme-Linked Immunoassay is sterile or single-use. However, as it is supplied as a ready-to-use kit for laboratory use, it is typically designed for single-use per the manufacturer’s instructions to ensure accuracy and reliability. Laboratories should follow the manufacturer’s guidelines for proper usage and disposal.
How is this assay supplied, and what should I expect when ordering?
The assay is supplied as a ready-to-use kit, meaning it comes pre-packaged with all necessary reagents and components for immediate use in a laboratory setting. Since it is intended for in vitro diagnostic use, the kit will include instructions for performing the enzyme-linked immunoassay, including sample preparation and measurement procedures. No additional sterilization or special handling instructions are mentioned in the data.
What regulatory pathway was followed for this device’s clearance, and which committee reviewed it?
This device was cleared through the traditional 510(k) pathway, specifically under the classification of a Class II device. The review was conducted by the Hematology (HE) Advisory Committee, and the decision was made on July 20, 1993, with the clearance number K931666. The device adheres to regulatory standards outlined in 21 CFR 864.7250, which governs erythropoietin assays.