# K090594: Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista Immunoglobulin M Flex Reagent Cartrid

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 29, 2009 after 55 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: 2 generations back to K860894 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm), Dade Behring, Inc. (2005) Summary page 1.

## Indications for use
Dimension Vista® IGM Flex ® reagent cartridge: The 1gM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma by means of nephelometry on the Dimension Vista® System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. Dimension Vista® IgA Flex® Reagent Cartridge: The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma by means of nephelometry on the Dimension Vista® System. Measurements of IgA aid in the diagnosis bf abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K090594
Methodology: https://510kreport.com/methodology