# K233663: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Dec 13, 2023 after 28 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: 7 generations back to K002852 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC, Siemens Healthcare Diagnostics (2009) Summary page 4.

## Indications for use
In-vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BN II and BN ProSpec® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K233663
Methodology: https://510kreport.com/methodology