Identifiers
- 510(k) Number
- K884260 FDA 510(k)
- FDA Product Code
- KLI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1700 FDA 510(k)
- Regulation Number
- 862.1700 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thyroxine Microassay is an enzyme immunoassay device used for the quantitative measurement of total thyroxine in human serum or plasma. This device is designed for in vitro diagnostic use in clinical laboratory settings to assess thyroid function by measuring thyroxine levels.
The Thyroxine Microassay is supplied as a single-use device and is not intended for MRI environments. It is stored according to manufacturer specifications and has received FDA 510(k) clearance with the product code KLI. The device is classified as Class II and is regulated under 862.1700.
Frequently asked questions
What is the Thyroxine Microassay used for?
The Thyroxine Microassay is an enzyme immunoassay device designed for the quantitative measurement of total thyroxine in human serum or plasma. It is used in clinical laboratory settings to assess thyroid function by measuring thyroxine levels.
Is the Thyroxine Microassay a single-use device?
Yes, the Thyroxine Microassay is supplied as a single-use device and is not intended for MRI environments. It should be used according to manufacturer specifications and discarded after a single use.
What regulatory approvals does the Thyroxine Microassay have?
The Thyroxine Microassay has received FDA 510(k) clearance with the product code KLI. It is classified as Class II and is regulated under 862.1700. The device is substantially equivalent to other marketed devices for the same purpose.
How should the Thyroxine Microassay be stored?
The Thyroxine Microassay should be stored according to the manufacturer's specifications. Proper storage conditions are essential to maintain the integrity and accuracy of the test results.
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: THYROXINE MICROASSAY (K884260) — FDA 510 (k) | Innolitics, Thyroxine Microassay 510 (k) FDA Premarket Notification K884260 ..., PDF K884260 - Thyroxine Microassay, Device Listing 1994423270 - FDA.report, Diamedix Corp. — FDA 510 (k) clearances & recalls · 510k Monitor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884260 | Class II | Active |
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Manufacturer
- Manufacturer
- Diamedix Corp.
Sources (1)
- FDA 510(k) K884260 24 fields · synced Sep 22, 2026