Biotrol Reference Calibrator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Biotrol Reference

510(k) Number

K873118 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Biotrol, USA, Inc. →

• What is the Biotrol Reference Calibrator used for?

  The Biotrol Reference Calibrator is designed as a multi-analyte liquid mixture for calibrating clinical chemistry instruments. It delivers standardized reference values to maintain accuracy and consistency in laboratory testing, helping ensure reliable diagnostic results for various analytes.

• How is the Biotrol Reference Calibrator supplied and intended for use?

  The calibrator is supplied as a liquid in a single-use format, requiring no sterilization before use. It is intended exclusively for in vitro clinical chemistry applications within laboratory settings, ensuring precise calibration without the need for reprocessing.

• Is the Biotrol Reference Calibrator reusable or single-use?

  This device is explicitly designed for single-use only. After opening or use, it should not be reused to prevent contamination or loss of accuracy, as its liquid formulation is not intended for reprocessing or repeated calibration cycles.

• How should the Biotrol Reference Calibrator be stored?

  Storage instructions must be followed strictly to preserve stability and accuracy. Typically, this involves keeping the calibrator refrigerated (unless otherwise specified) and protected from light, extreme temperatures, or physical damage. Always refer to the manufacturer’s guidelines for exact storage conditions.

• What regulatory pathway does the Biotrol Reference Calibrator follow?

  The Biotrol Reference Calibrator has received FDA 510(k) clearance and is classified as a Class II device under FDA regulations. This designation reflects its role as a critical tool for ensuring calibration consistency in clinical chemistry assays, with substantial equivalence determined through the traditional 510(k) review process.