Identifiers
- 510(k) Number
- K872447 FDA 510(k)
- FDA Product Code
- KHQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1715 FDA 510(k)
- Regulation Number
- 862.1715 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CEDIA T Uptake is a radioassay for measuring triiodothyronine uptake, a diagnostic test used in clinical chemistry to evaluate thyroid function. It employs a chemiluminescent enzyme immunoassay (CEDIA) technology to quantify the binding capacity of thyroid hormone transport proteins in serum or plasma, aiding in the assessment of thyroid status and metabolic disorders.
This device is supplied as a reagent/calibrator kit (version/model 100049) for use in automated clinical chemistry analyzers under CLIA Non-Waived standards. It is classified under FDA product code KHQ and falls under Class II – Special Controls with an FDA 510(k) clearance (K872447). The kit is intended for single-use in regulated laboratory settings and requires adherence to standard immunoassay handling protocols.
Frequently asked questions
What clinical chemistry applications does the CEDIA(TM) T Uptake support in evaluating thyroid function?
The CEDIA(TM) T Uptake is designed to measure triiodothyronine uptake in serum or plasma using chemiluminescent enzyme immunoassay (CEDIA) technology. This diagnostic test helps assess thyroid hormone transport protein binding capacity, which aids clinicians in evaluating thyroid status and identifying metabolic disorders related to thyroid function.
Is this device intended for use in automated clinical chemistry analyzers, and if so, what regulatory standards apply?
Yes, the CEDIA(TM) T Uptake is supplied as a reagent/calibrator kit (version/model 100049) specifically for use in automated clinical chemistry analyzers. It adheres to CLIA Non-Waived standards, ensuring compliance with laboratory regulations for diagnostic testing in clinical settings.
How is the CEDIA(TM) T Uptake kit intended to be used, and is it reusable?
The kit is intended for single-use only in regulated laboratory settings. It follows standard immunoassay handling protocols, meaning each kit is designed for one test cycle and should not be reused to maintain accuracy and sterility.
What regulatory pathway was followed for FDA clearance of this device, and what product code does it fall under?
The CEDIA(TM) T Uptake received FDA 510(k) clearance (K872447) under the Traditional clearance type, classified as Class II – Special Controls with a product code of KHQ. This indicates it was reviewed by the Clinical Chemistry (CH) Advisory Committee and deemed substantially equivalent to a predicate device.
What type of sample (serum/plasma) is compatible with this test, and how is it supplied?
The CEDIA(TM) T Uptake is designed for use with serum or plasma samples. It is supplied as a reagent/calibrator kit (version/model 100049), which includes all necessary components for performing the chemiluminescent enzyme immunoassay in an automated clinical chemistry analyzer.
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: CEDIA (TM) T UPTAKE (K872447) — FDA 510 (k) | Innolitics, K872447 FDA 510(k) - CEDIA(TM) T UPTAKE | Microgenics Corp., CEDIA T Uptake - BEUDAMED, PDF K872447 CEDIA(TM) T UPTAKE - 510kdatabase.net, Immunoassay Reagent / Calibrator Kit CEDIAﾮ - McKesson
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 | K872447 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K872447 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026