Lithium Micro Volume Electrode, Theophylline, ISE Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and AbtroL

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K063705 ↗

FDA Product Code

NDW

Device Class

Class II

Regulation

21 CFR Part 862.3560

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Datapro Clinical Chelistry Analyzer

  Class II

  FDA 510(k) K042767 Active Cleared 27 Apr 2005

• Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control Serum

  Class I

  FDA 510(k) K052056 Active Cleared 23 Sep 2005

• Thermo Electron Angiotensin Converting Enzyme Infinity (Ace) Reagent

  Class II

  FDA 510(k) K041657 Active Cleared 30 Aug 2004

• Carbamazepine, Valproic Acid, Tdm Calibration Set B and Abtrol, Nortrol Controls

  Class II

  FDA 510(k) K063131 Active Cleared 5 Oct 2007

• Phenobarbital, Phenytoin, Tdm Calibration Set B and Abtrol/Nortrol Controls

  Class II

  FDA 510(k) K063145 Active Cleared 17 Oct 2007

• Complement C3 and C4, Specical Calibrator and Specitrol Control and High Control

  Class II

  FDA 510(k) K063150 Active Cleared 19 Mar 2007

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• What clinical applications does this calibration set support in a lab setting?

  This TDM Calibration Set is specifically designed for quantitative measurements in clinical toxicology, ensuring accurate assay performance for therapeutic drug monitoring (TDM). It supports calibrations for theophylline, lithium, potassium, sodium, and chloride in human serum or plasma, which are critical for monitoring drug levels in patients to prevent toxicity or under-dosing.

• Are the calibrators in this set intended for single-use or reusable, and how should they be handled?

  The calibrators in this set are intended for single-use per bottle or bag, meaning each bottle or bag should be used once before disposal. The lithium micro volume electrodes, however, are part of a reusable calibration tool for laboratory use, allowing them to be used across multiple calibration sessions.

• What sizes or models are included in this calibration set, and how are they differentiated?

  This set includes three calibrators labeled as ISE Calibrators 1, 2, and 3, along with lithium micro volume electrodes. The calibrators are differentiated by their assigned numbers (1, 2, and 3) and are used in conjunction with the electrodes for precise calibration of ion-selective measurements. The set also includes additional components like Nortrol and Abtrol, which are likely reference standards for theophylline and other analytes.

• How is this device regulated, and what does the FDA clearance indicate about its safety and effectiveness?

  This device is authorized under FDA 510(k) clearance (K063705) and is classified as Class II, indicating it has been determined to be substantially equivalent to a legally marketed device. The clearance process ensures that the device meets regulatory standards for safety and performance, specifically for use in clinical toxicology applications as outlined in the submission.

• Is this calibration set compatible with any specific laboratory equipment or systems?

  While the data does not specify exact equipment compatibility, this TDM Calibration Set is designed for use with ion-selective electrode (ISE) systems commonly found in clinical laboratories. It is intended to work with standard laboratory tools for therapeutic drug monitoring, ensuring accurate calibration of measurements for theophylline, lithium, potassium, sodium, and chloride in human serum or plasma.