Architect GALECTIN-3 Reagent Kit, Calibrators, Controls
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140436 FDA 510(k)
- FDA Product Code
- OSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1117 FDA 510(k)
- Regulation Number
- 862.1117 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a Galectin-3 In Vitro Diagnostic Assay, designed for the quantitative determination of galectin-3 antigen in human serum and EDTA plasma. Galectin-3 is a biomarker used in clinical chemistry to aid in the assessment of conditions such as heart failure and fibrosis. This assay is intended for use on the Architect i System, a fully automated immunoassay analyzer.
The kit includes reagent components, calibrators, and controls for in vitro diagnostic use. Supplied as a Class II device under FDA regulation 862.1117, it is intended for single-use and requires proper storage as specified in the accompanying instructions. The product received FDA clearance via a 510(k) submission (K140436) under the Traditional clearance type, with a decision date of December 23, 2014. Sterility and performance are validated for clinical laboratory settings.
Frequently asked questions
What clinical conditions is the ARCHITECT GALECTIN-3 assay intended to help assess, and how does it do so?
The ARCHITECT GALECTIN-3 assay quantifies galectin-3 antigen levels in human serum and EDTA plasma to aid in evaluating conditions like heart failure and fibrosis. Galectin-3 is a biomarker linked to these conditions, and its measurement helps clinicians assess disease progression or response to treatment in clinical chemistry settings.
Is this assay compatible with any specific laboratory equipment, and if so, what are the requirements for use?
Yes, the ARCHITECT GALECTIN-3 assay is designed exclusively for use on the Architect i System, a fully automated immunoassay analyzer. The kit includes reagents, calibrators, and controls tailored for this platform, ensuring accurate and consistent results within its automated workflow.
How is the ARCHITECT GALECTIN-3 kit supplied, and is it intended for single-use or repeated testing?
The kit is supplied as a complete set of reagent components, calibrators, and controls for in vitro diagnostic use. It is explicitly intended for single-use per the manufacturer’s instructions, meaning each kit should not be reused after opening or expiration. Proper storage per the accompanying instructions is required to maintain sterility and performance.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinical laboratories?
The ARCHITECT GALECTIN-3 assay received FDA clearance through a 510(k) submission (K140436) under the *Traditional clearance type*, demonstrating it is substantially equivalent to a legally marketed predicate device. This means it meets FDA standards for safety and effectiveness as an in vitro diagnostic device for clinical chemistry applications, allowing authorized laboratories to use it for galectin-3 testing.
Are there any special storage requirements for the ARCHITECT GALECTIN-3 kit components, and how should they be handled?
While the exact storage conditions are detailed in the accompanying instructions, the kit’s components—including reagents, calibrators, and controls—must be stored according to the manufacturer’s specifications to preserve sterility and performance. Typically, this involves refrigeration or freezing (as specified) and protection from light or contamination until use. Always refer to the provided documentation for precise guidelines.
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 GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS ..., PDF 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ..., ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS ..., ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140436 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujirebio Diagnostics, Inc.
- FDA Applicant
- Fujirebio Diagnostics,Inc.
Sources (1)
- FDA 510(k) K140436 24 fields · synced Sep 20, 2026