Architect Homocysteine Reagents, Calibrators and Controls
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073640 FDA 510(k)
- FDA Product Code
- LPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1377 FDA 510(k)
- Regulation Number
- 862.1377 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Architect Homocysteine Reagents, Calibrators and Controls is a quantitative in vitro diagnostic device for measuring total L-homocysteine in human serum or plasma. It is designed as part of the ARCHITECT i System, providing reagents, calibrators, and controls to support accurate homocysteine quantification in clinical chemistry applications. The device operates within the Class II regulatory classification, adhering to standards for analytical precision and reliability in laboratory settings.
This system is intended for in vitro use only and is supplied as a kit containing reagents, calibrators, and controls for the ARCHITECT i System. It is not sterile and is intended for single-use per batch. The device is regulated under FDA 510(k) clearance (K073640) and falls under the Clinical Chemistry specialty, with compliance to 21 CFR Part 862.1377. Storage and handling must follow manufacturer guidelines to maintain test integrity, though no specific sterility or MRI safety requirements are noted.
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: Architect Homocysteine Reagents, Calibrators and Controls (K073640 ..., PDF REVIEW MEMORANDUM - Food and Drug Administration, Architect Homocysteine Reagents, Calibrators and Controls, PDF APR 2 4 2008 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073640 | Class II | Active |
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Manufacturer
- Manufacturer
- Axis-Shield Diagnostics, Ltd.
Sources (1)
- FDA 510(k) K073640 24 fields · synced Sep 19, 2026