Thermo Scientific QMS Everolimus Reagents, Calibrators and Controls
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- QMS Everolimus Immunoassay Control Set FDA UDI
- Generic Name
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- QMS Everolimus Control EUDAMED
- Model / Reference
- 0373878 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883004597 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884883004597 EUDAMED
- 510(k) Number
- K100144 FDA 510(k)
- FDA Product Code
- OUF FDA 510(k)LAS FDA UDI
- EMDN Code
- W0102080606 EVEROLIMUS EUDAMED
- GMDN Term
- Rapamycin (sirolimus) therapeutic drug monitoring IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)Class I FDA UDI
- Legislation / Framework
- 21 CFR Part 862.3840 FDA 510(k)
- Regulation Number
- 862.3840 FDA 510(k)862.3280 FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
This device is an Everolimus Immunoassay reagent set, designed for quantitative measurement of everolimus in biological samples. It includes calibrators, controls, and reagents for use in immunoassay testing, enabling accurate detection and monitoring of the drug’s concentration in clinical toxicology applications.
The QMS Everolimus Reagents, Calibrators and Controls are supplied as a kit for in vitro diagnostic use, intended for single-use only. They are regulated under the FDA’s 510(k) pathway (K100144) and the In Vitro Diagnostic Device Directive (IVDD), with a classification of Class II. Storage and handling must comply with manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What clinical area is this immunoassay kit primarily used for, and why is it important in that field?
This kit is designed for clinical toxicology, specifically for measuring everolimus levels in biological samples. It’s critical in this field because everolimus is an immunosuppressive drug used post-transplant, and precise monitoring helps avoid toxicity (e.g., organ damage) or underdosing (e.g., graft rejection). The quantitative assay ensures accurate drug concentration tracking, supporting patient safety and treatment efficacy.
Is this kit reusable, or is it meant for single-use only? How does that affect its storage and handling?
The kit is intended for single-use only, as explicitly stated in the manufacturer’s instructions. This design minimizes contamination risks and ensures consistent, reliable results per batch. Storage must follow the manufacturer’s guidelines to preserve sterility and performance—typically refrigerated or frozen until use, with strict adherence to expiration dates to prevent degradation of reagents, calibrators, or controls.
What regulatory pathways does this device follow, and how does that classification impact its use in clinical settings?
The kit is regulated under the FDA’s 510(k) pathway (K100144) and the In Vitro Diagnostic Device Directive (IVDD), with a Class II classification. This classification indicates moderate risk, requiring validation of performance (e.g., accuracy, precision) but not the stringent scrutiny of Class III devices. Clinically, this means it’s subject to routine quality control checks and compliance with manufacturer protocols to ensure reliable everolimus measurement for patient monitoring.
How are the calibrators and controls included in this kit used, and why are they essential for accurate testing?
The kit includes calibrators (to define the concentration scale for everolimus) and controls (to verify assay performance across batches). Calibrators ensure the assay’s linearity and accuracy by mapping measured signals to known drug concentrations, while controls (e.g., low/high-level) confirm reproducibility and detect assay drift or errors. Without them, results could be unreliable, leading to misdiagnosis of drug levels or treatment failures.
What should clinicians or labs consider when ordering this kit, beyond just the device itself?
Clinicians or labs should verify compatibility with their assay platform (e.g., automated immunoassay systems) and confirm the kit’s expiration date upon receipt, as reagents degrade over time. Additionally, they must ensure proper storage conditions (e.g., refrigeration) are maintained to preserve sterility and functionality. Training staff on handling single-use components and interpreting results within the kit’s specified limits is also critical for clinical validity.
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, DE - Thermo Fisher Scientific, Thermo Scientific - Fisher Sci, Thermo Fisher Scientific – Wikipedia, Thermo Fisher Scientific - Wikipedia
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 | K100144 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
- FDA Applicant
- Microgenics Corp.
Sources (3)
- FDA 510(k) K100144 24 fields · synced Sep 18, 2026
- FDA UDI bced6050-95ed-4d09-9468-0bd6547e80ae 32 fields · synced May 30, 2026
- EUDAMED 3280ea14-fd20-414b-bfc1-c1af1f53a357 61 fields · synced Jul 9, 2026