Identifiers
- 510(k) Number
- K090282 FDA 510(k)
- FDA Product Code
- KLR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3555 FDA 510(k)
- Regulation Number
- 862.3555 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QMS Lidocaine assay is an enzyme immunoassay intended for the quantitative determination of lidocaine in human serum or plasma. It is used in the diagnosis and treatment of lidocaine overdose and in monitoring therapeutic drug levels to ensure appropriate therapy.
This ready-to-use liquid assay is designed for automated clinical chemistry analyzers and is supplied in a single-use format. It is not sterilized and requires storage at room temperature. The device is regulated under FDA 510(k) clearance.
Frequently asked questions
What is the QMS Lidocaine assay used for?
It is an enzyme immunoassay intended for the quantitative determination of lidocaine in human serum or plasma. It is used in the diagnosis and treatment of lidocaine overdose and in monitoring therapeutic drug levels to ensure appropriate therapy.
How is the assay supplied and stored?
The assay is supplied as a ready-to-use liquid format in a single-use format. It is not sterilized and requires storage at room temperature.
What type of analyzer is the QMS Lidocaine assay designed for?
The assay is designed for automated clinical chemistry analyzers.
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: PDF QMS Lidocaine (LIDO) - Thermo Fisher Scientific, QMS™ Therapeutic Drug Monitoring (TDM) Assays - Thermo Fisher Scientific, Thermo Scientific™ QMS™ Therapeutic Drug Monitoring (TDM) Assays
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090282 | Class II | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific, Inc.
Sources (1)
- FDA 510(k) K090282 24 fields · synced Sep 25, 2026