# K063272: Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 26, 2007 after 88 days
- Product code: JZG (System, Test, Beta-2-Microglobulin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002852 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002731: N Latex B2-Microglobulin, Dade Behring, Inc. (2000) Summary page 1.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 1.
- K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001) Summary page 1.

## Indications for use
The B2MIC method is an in vitro diagnostic test for the quantitative determination of β2-microglobulin in human serum, or heparinized or EDTA plasma on the Dimension Vista® System. Measurements of β2-microglobulin aid in the diagnosis of renal dysfunction. PROT1 CAL is an in vitro diagnostic product for the calibration of the β2-microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (QGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista System. PROT1 CON M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of β2-microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin / transthyretin (PREALB) on the Dimension Vista® System.

Source page: https://510kreport.com/device/K063272
Methodology: https://510kreport.com/methodology