Thermo Scientific QMS Tacrolimus Assay and Calibrators
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123343 FDA 510(k)
- FDA Product Code
- MLM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1678 FDA 510(k)
- Regulation Number
- 862.1678 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thermo Scientific QMS Tacrolimus Assay and Calibrators is an enzyme immunoassay designed for the quantitative measurement of tacrolimus in human serum or plasma. Tacrolimus is a calcineurin inhibitor used to prevent organ transplant rejection, particularly in kidney, liver, and heart transplants, by suppressing the immune system.
This assay is supplied as a liquid, ready-to-use reagent kit intended for in vitro diagnostic use in clinical chemistry laboratories. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance and IVDD authorization. The calibrators are provided to ensure accurate assay performance, and the system is intended for single-use only, with no specific MRI safety considerations noted.
Frequently asked questions
What is the Thermo Scientific QMS Tacrolimus Assay intended to measure, and in which biological samples can it be used?
The Thermo Scientific QMS Tacrolimus Assay is designed for the quantitative measurement of tacrolimus, a calcineurin inhibitor used to prevent organ transplant rejection. It is specifically intended for use in human serum or plasma samples, making it suitable for monitoring patients who have undergone kidney, liver, or heart transplants.
How is the Thermo Scientific QMS Tacrolimus Assay supplied, and is it ready to use?
The assay is supplied as a liquid, ready-to-use reagent kit. This means no additional preparation steps are required before use, simplifying workflow in clinical chemistry laboratories. The kit includes the necessary reagents and calibrators for accurate testing.
Is the Thermo Scientific QMS Tacrolimus Assay single-use or reusable, and what does this mean for clinical workflows?
The assay is intended for single-use only, meaning each kit should be used for one testing session. This design ensures consistency and reliability in results while minimizing the risk of cross-contamination or degradation of reagents over time, which is critical for accurate tacrolimus monitoring in transplant patients.
What regulatory pathways has the Thermo Scientific QMS Tacrolimus Assay undergone, and what does this imply for its use in clinical settings?
The assay has received FDA 510(k) clearance and IVDD authorization, confirming it meets regulatory standards for safety and performance as a Class II device. This implies it has been evaluated for clinical chemistry applications and is suitable for use in accredited laboratories under the relevant regulatory frameworks.
Are there any special storage requirements or considerations for the Thermo Scientific QMS Tacrolimus Assay?
While the exact storage conditions are not detailed in the provided data, the assay is supplied as a liquid reagent kit, which typically requires refrigeration (e.g., 2–8°C) to maintain stability and efficacy. Laboratories should follow the manufacturer’s instructions for storage to ensure optimal performance and prevent degradation of the assay components.
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: Thermo Fisher Scientific - DE, QMS™ Tacrolimus Immunoassays and Calibrators - Thermo Fisher Scientific, DE - Thermo Fisher Scientific, PDF QMS® Tacrolimus Calibrators - Thermo Fisher Scientific
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 | K123343 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (2)
- FDA 510(k) K123343 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026