# K221114: Immunoglobulin G (IgG)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
- Decided: Aug 2, 2023 after 474 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: 4 generations back to K943997 (1994). 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)
- K162208: DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent, Beckman Coulter, Inc. (2017) Summary page 4.

## Indications for use
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on Beckman Coulter AU/DxC 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/K221114
Methodology: https://510kreport.com/methodology