# K110874: Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 20, 2012 after 297 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 K992858 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 2.
- K052788: N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H, Dade Behring, Inc. (2006) Summary page 2.

## Indications for use
Reagent: for in vitro diagnostic use in the quantitative determination of β2-microglobulin in human serum or plasma (lithium heparin and potassium EDTA) on ADVIA 1650 Chemistry systems. The ADVIA 1650 Chemistry β2-Microglobulin (B2M) assay aids in the diagnosis of active rheumatoid arthritis and kidney disease. Calibrator: for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry β2-Microglobulin method

Source page: https://510kreport.com/device/K110874
Methodology: https://510kreport.com/methodology