# K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 15, 2005 after 137 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: 1 generation back to K860894 (1986). 1 ancestor in all.
10 later devices descend from it; 6 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 1.

## Most influential descendants
- K061338: Dimension Vista Iga Flex Reagent Cartridge Assay (2006), 7 descendants of its own
- K062055: Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High (2006), 6 descendants of its own
- K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an (2007), 5 descendants of its own
- K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H (2007), 4 descendants of its own
- K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC (2009), 1 descendant of its own

## Indications for use
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma as well as IgG in human cerebrospinal fluid (CSF) using the BN™ Systems. Measurements of these immunoglobulins 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/K042735
Methodology: https://510kreport.com/methodology