# K162208: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 9, 2017 after 157 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943997 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073490: Olympus Igg Reagent, Olympus America, Inc. (2008) Summary page 4.

## Most influential descendants
- K221114: Immunoglobulin G (IgG) (2023), 0 descendants of its own

## Indications for use
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU analyzers. The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K162208
Methodology: https://510kreport.com/methodology