# K983895: Immage Immunochemistry System Beta-2 Microglobulin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 25, 1998 after 22 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: 1 generation back to K940353 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940353: Beckman Beta-2-Microglobulin (B2M), Beckman Instruments, Inc. (1994). Our OCR of the scanned summary read K840353, FDA’s number for Pacemaker Pulse Generator W/Electrode (Ross Research, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Array Beta-2-Microglobulin (B2M)”.

## Indications for use
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry. Clinical Significance: An increase in the concentration of serum beta-2-microglobulin can resuit from an overproduction of the protein by nucleated cells and/or decreased clearance by the kidneys. Under normal conditions, beta-2-microglobulin passes readily through the glomerular membrane. Levels of beta-2-microglobulin in serum, therefore, are inversely proportional to glomerular filtration rate (GFR). Measurement of Beta-2-Microglobulin in serum or plasma assists in the diagnosis and management of patients with active rheumatoid arthritis and renal disease.

Source page: https://510kreport.com/device/K983895
Methodology: https://510kreport.com/methodology