THB Cal Standard for IL CO-Oximeters/Oximeters

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K962864 ↗

FDA Product Code

KRZ

Device Class

Class II

Regulation

21 CFR Part 864.8165

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Alko Diagnostic Corp. →

• What is the THB Cal Standard for IL CO-Oximeters/Oximeters used for?

  The THB Cal Standard is designed specifically to calibrate the total hemoglobin (tHb) channel of Instrumentation Laboratory CO-Oximeters and Oximeters. This ensures precise and reliable blood gas and oximetry analysis in clinical laboratory settings, helping maintain accurate diagnostic results for hemoglobin and hematocrit measurements.

• Is the THB Cal Standard single-use or reusable?

  The THB Cal Standard is supplied as a single-use diagnostic reagent. This design choice ensures sterility and consistency for each calibration, reducing the risk of contamination or degradation over repeated use.

• Who can use the THB Cal Standard, and where is it intended for use?

  This calibrator is intended for use in clinical laboratory environments by trained technicians or laboratory personnel. It is not intended for point-of-care or home-use settings, as it requires specialized equipment and expertise to perform accurate calibrations.

• How does the THB Cal Standard differ from the original equipment manufacturer’s dye reference standard?

  The THB Cal Standard is a replacement for the original equipment manufacturer’s dye reference standard, providing a standardized solution for calibrating the tHb channel. It is designed to ensure compatibility with Instrumentation Laboratory CO-Oximeters and Oximeters, maintaining accuracy and consistency in hemoglobin and hematocrit measurements.

• What regulatory pathway does the THB Cal Standard follow?

  The THB Cal Standard is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K962864. It is classified as a Class II in vitro diagnostic device and adheres to regulatory standards for hematology diagnostics, ensuring compliance with U.S. medical device regulations.