Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High

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

510(k) Number

K063272 ↗

FDA Product Code

JZG

Device Class

Class II

Regulation

21 CFR Part 866.5630

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What types of patient specimens can the Dimension Vista B2MIC Flex Reagent Cartridge analyze for β2-microglobulin levels?

  The cartridge is designed to measure β2-microglobulin in human serum, heparinized plasma, and other compatible specimens. It uses a monoclonal antibody-based immunoassay to provide quantitative results, which helps assess renal function and monitor conditions like multiple myeloma or chronic kidney disease.

• How many tests can a single cartridge perform, and how is it packaged?

  Each cartridge contains 12 wells and is capable of generating approximately 100 tests. They are supplied in cartons of two cartridges each, ensuring a convenient quantity for routine use. The cartridges are pre-filled with reagents and intended for single-use only.

• What components are included in the kit for calibration and quality control?

  The kit includes a Protein 1 Calibrator, Control Medium (for baseline quality assurance), and Control High (for assessing higher β2-microglobulin levels). These components help ensure accurate calibration and reliable test results when used with the Dimension Vista® System.

• Is the Dimension Vista B2MIC Flex Reagent Cartridge reusable, or is it intended for single-use?

  The cartridge is explicitly designed for single-use only. It is pre-filled with reagents and intended to be discarded after use to maintain accuracy, sterility, and compliance with best practices for immunoassay testing.

• What system is required to operate this cartridge, and how is it supplied?

  The cartridge is intended for use exclusively with the Dimension Vista® System, a dedicated clinical analyzer. It is supplied as a pre-filled, single-use cartridge in cartons of two, each containing all necessary reagents for approximately 100 tests. The system integrates with the cartridge for automated processing.