VITROS Chemistry Products Calibrator Kit 3

No FDA recalls found in the data synced 23 Oct 2026.

510(k) Number

K161140 ↗

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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• What is the VITROS Chemistry Products Calibrator Kit 3 used for in a clinical setting?

  The VITROS Chemistry Products Calibrator Kit 3 is a multi-analyte mixture designed specifically for calibrating the VITROS 250/950 Chemistry Systems. It provides standardized reference values to ensure accurate and consistent measurement of biochemical analytes in patient samples, which is critical for reliable diagnostic testing in clinical chemistry.

• How should the VITROS Chemistry Products Calibrator Kit 3 be stored, and why?

  This kit must be stored frozen to maintain its stability and integrity. The manufacturer explicitly states it is non-returnable and requires adherence to frozen storage conditions, as deviations could compromise the accuracy of the calibrator’s reference values.

• Is the VITROS Chemistry Products Calibrator Kit 3 intended for single-use or repeated use?

  The kit is designed for calibration purposes and is not explicitly labeled as single-use or reusable in the provided data. However, since it is a calibrator mixture and not a consumable reagent for patient testing, it is typically used once per calibration cycle to ensure precision. Always follow the manufacturer’s instructions for proper usage.

• What regulatory pathway was followed for FDA clearance of this device?

  The VITROS Chemistry Products Calibrator Kit 3 received FDA clearance through a 510(k) submission, classified as Class II under the Abbreviated clearance type. The decision was made by the Clinical Chemistry (CH) advisory committee, and the submission was deemed Substantially Equivalent (SESE) to a predicate device, as indicated by the decision code.

• Are there any special handling precautions for this calibrator kit due to its contents?

  Yes, the kit contains blood derivatives, which means it should be handled as potentially infectious material. Standard biosafety precautions, such as wearing gloves and using appropriate disposal methods, should be followed to ensure safety for laboratory personnel.