Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control

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

510(k) Number

K062035 ↗

FDA Product Code

JIX

Models / Variants

Dimension Vista Rf Flex Reagent Cartridge

Protein 2 Calibrator And Control

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 Dade Behring, Inc. →

• What is the Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control used for in a clinical setting?

  This device is designed for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma. It is used within the Dimension Vista System to provide standardized reference values for accurate assay performance, aiding in the diagnostic evaluation of conditions like rheumatoid arthritis.

• Is the Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control intended for single-use or reusable applications?

  The cartridge is explicitly labeled as a single-use reagent cartridge. It is not designed for reuse, ensuring consistent performance and safety standards for each diagnostic test.

• What type of sterility does the Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control have, and why?

  The cartridge is supplied as non-sterile. This is because it is intended for in vitro diagnostic use only, where sterility is not required for its function, and it is not used in invasive procedures.

• How is this device compatible with the Dimension Vista System, and what does that mean for users?

  The cartridge is specifically designed for use with the Dimension Vista System, meaning it integrates seamlessly with the system’s protocols for RF testing. Users must ensure their laboratory equipment matches this compatibility to achieve accurate and reliable assay results.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that imply for its use?

  The device received FDA 510(k) clearance through a traditional review process, determined to be substantially equivalent to a predicate device. This implies it meets established safety and performance standards for Class II medical devices under FDA regulations, ensuring its reliability for clinical chemistry applications.