Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, And Ids Isys Di…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123763 FDA 510(k)
- FDA Product Code
- CIB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1085 FDA 510(k)
- Regulation Number
- 862.1085 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IDS-iSYS Direct Renin Assay is a radioimmunoassay for quantitative determination of direct renin in human EDTA plasma. It is designed for use on the IDS-iSYS Multi-Discipline Automated System, enabling precise measurement of renin levels to support clinical chemistry diagnostics. The accompanying Control Set and Calibration Verifiers ensure accuracy and reliability of assay performance, adhering to regulatory standards for in vitro diagnostic devices.
This system is intended for laboratory use and is supplied as a sterile, single-use component kit. The assay operates within the constraints of Class II (Special Controls) regulatory classification, with FDA 510(k) clearance and IVDD compliance. Proper storage requires adherence to manufacturer guidelines, and usage is restricted to qualified clinical chemistry settings. No MRI safety considerations are specified, and device sizes or additional technical specifications are not detailed in the regulatory data.
Frequently asked questions
What is the primary purpose of the IDS-iSYS Direct Renin Assay, and how does it differ from other renin measurement methods?
The IDS-iSYS Direct Renin Assay is designed for quantitative measurement of direct renin in human EDTA plasma, specifically using a radioimmunoassay technique. Unlike traditional methods that may rely on indirect renin activity assays (e.g., angiotensin I generation), this system directly measures renin levels, providing precise clinical chemistry diagnostics. It is optimized for use on the IDS-iSYS Multi-Discipline Automated System, ensuring accuracy and reproducibility in laboratory settings.
Is the IDS-iSYS Direct Renin Assay kit single-use, and if so, what does this mean for workflow efficiency in a clinical lab?
Yes, the assay is supplied as a sterile, single-use component kit, meaning each kit is intended for one-time use only. This design minimizes cross-contamination risks and reduces the need for reprocessing or validation between runs, streamlining workflow efficiency in clinical chemistry labs. However, the accompanying Control Set and Calibration Verifiers may be reused across multiple assay runs to ensure ongoing accuracy and compliance with regulatory standards.
What regulatory pathways does this device follow, and how does that affect its use in clinical settings?
The IDS-iSYS Direct Renin Assay holds FDA 510(k) clearance under the Traditional pathway and complies with In Vitro Diagnostic Device Directive (IVDD) standards. This classification ensures it meets stringent regulatory requirements for safety, performance, and clinical chemistry applications. Clinicians and labs can rely on its compliance to validate results for diagnostic purposes, though usage remains restricted to qualified clinical chemistry settings as specified by the manufacturer.
Are there any special storage requirements for the IDS-iSYS Direct Renin Assay, and how might this impact inventory management?
While the exact storage conditions aren’t detailed in the regulatory data, the manufacturer’s guidelines (referenced in the description) must be followed to maintain sterility and performance. Since the assay is single-use, labs should plan inventory management to account for expiration dates and proper handling to avoid waste. Adhering to these guidelines ensures the assay remains effective for its intended use in measuring renin levels.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IDS-iSYS Direct Renin - IDS, Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, and Ids ..., PDF 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ..., PDF Overview and Clinical Application Update of the IDS-iSYS Direct Renin ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K123763 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems , Ltd.
Sources (2)
- FDA 510(k) K123763 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026