Luminex Flexmap 3d Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121399 FDA 510(k)
- FDA Product Code
- NSU FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.2570 FDA 510(k)
- Regulation Number
- 862.2570 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Luminex Flexmap 3D Instrument System with Xponent 4.0 SP Software is a clinical multiplex test system that measures and sorts multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is designed to work with specific IVD cleared or approved assays that cite its use, measuring multiple similar analytes that establish diagnostic results. The system includes the Flexmap 3D instrument, Xponent 4.0 SP software, and the Flexmap 3D IVD Calibration Kit.
The system is supplied with the Flexmap 3D IVD Calibration Kit which contains all reagents needed for 25 calibrations and should be stored at 2-8°C. The device is intended for use in clinical chemistry settings and is regulated under FDA 510(k) clearance with device class 2. The system includes multiple registration numbers and is manufactured by Luminex Corp. in Austin, Texas.
Frequently asked questions
What is the purpose of the Luminex Flexmap 3D Instrument System?
The Luminex Flexmap 3D Instrument System is a clinical multiplex test system designed to measure and sort multiple signals generated in in vitro diagnostic assays from clinical samples. It works with specific IVD cleared or approved assays to establish diagnostic results by measuring multiple similar analytes.
What components are included in the system and how is it supplied?
The system includes the Flexmap 3D instrument, Xponent 4.0 SP software, and the Flexmap 3D IVD Calibration Kit. The calibration kit contains all reagents needed for 25 calibrations and should be stored at 2-8°C. The device is intended for use in clinical chemistry settings.
What is the regulatory status of this device?
The Luminex Flexmap 3D Instrument System is regulated under FDA 510(k) clearance with device class 2. It has been determined to be substantially equivalent to other devices in this category and is designed for use with specific IVD cleared or approved assays that cite its use.
Who manufactures this system and where is it produced?
The Luminex Flexmap 3D Instrument System is manufactured by Luminex Corp. in Austin, Texas. The company is located at 12212 Technology Blvd., Austin, TX 78727, and the device has multiple registration numbers associated with its production.
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: Luminex Flexmap 3d Instrument System, Luminex Xponent 4.0 Spi Software ..., Luminex Corporation - Wikipedia, PDF 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121399 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Corp.
Sources (1)
- FDA 510(k) K121399 24 fields · synced Oct 6, 2026