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Thermo Scientific QMS Multi-Constituent Calibrator

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K120936

by Microgenics Corporation

Identifiers

510(k) Number
K120936 FDA 510(k)
FDA Product Code
DKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3200 FDA 510(k)
Regulation Number
862.3200 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Calibrator, Drug Mixture, designed for in vitro diagnostic use. It provides standardized reference materials for calibrating clinical laboratory assays that measure multiple therapeutic drug concentrations in human serum and plasma, including Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin.

The calibrator is intended for use on clinical laboratory analyzers and is supplied as a multi-constituent solution. It is classified under FDA regulation 862.3200 and holds an FDA 510(k) clearance (K120936) with a decision of Substantially Equivalent (SESE). The product code is DKB, and it is intended for single-use diagnostic applications in clinical toxicology settings.

Frequently asked questions

What therapeutic drugs does this calibrator measure concentrations for in clinical laboratory assays?

This calibrator is designed to provide standardized reference materials for calibrating assays that measure concentrations of ten specific drugs: Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin in human serum and plasma. It is intended for use in clinical toxicology settings to ensure accurate drug level monitoring.

Is this calibrator intended for single-use or repeated use in a clinical setting?

The device is explicitly intended for single-use diagnostic applications in clinical toxicology. It is supplied as a multi-constituent solution and should not be reused after opening, as this could compromise accuracy and sterility.

What types of clinical laboratory analyzers can this calibrator be used with?

While the device is not explicitly limited to specific analyzers, it is designed for in vitro diagnostic use on clinical laboratory analyzers that measure multiple therapeutic drug concentrations in serum and plasma. Compatibility depends on the analyzer’s ability to process multi-constituent calibrators for drugs like those listed (e.g., Amikacin, Digoxin, Vancomycin). Always verify compatibility with your analyzer’s manufacturer guidelines.

How is this calibrator supplied, and what should I consider for storage?

The calibrator is supplied as a multi-constituent solution—likely in liquid form—intended for single-use. Storage conditions are not detailed in the provided data, but typical liquid calibrators require refrigeration (e.g., 2–8°C) and protection from light. Check the label or manufacturer instructions for precise storage guidelines to maintain stability and accuracy.

What regulatory pathway was followed for this device’s approval, and what does that mean for me as a buyer?

This calibrator holds an FDA 510(k) clearance (K120936) under the Abbreviated pathway, classified as Substantially Equivalent (SESE) to a predicate device. It was reviewed by the Clinical Toxicology Advisory Committee and assigned the product code DKB (Calibrators, Drug Mixture). The clearance indicates it meets FDA standards for safety and effectiveness, but buyers should confirm compatibility with their laboratory’s workflows and local regulatory requirements.

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: Abbott Tdm Multiconstituent Calibrator, Thermo Scientific Qms Multi ..., ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO… - FDA.report, Abbott Tdm Multiconstituent Calibrator, Thermo Scientific Qms Multi ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microgenics Corporation

Sources (2)

  • FDA 510(k) K120936 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026