# K092283: Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista Immunoglobulin Igg

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Oct 21, 2009 after 84 days
- Product code: DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Siemens N Antisera to Human IgG Subclasses 1 and 2: named in the summary without a submission number
- (no number) Siemens N Latex IgG Subclasses 3 and 4: named in the summary without a submission number

## Indications for use
The IgG1 method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G subclass 1 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 1 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laborato-y findings. The IgG2 method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G subclass 2 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 2 aid in the diagnosis of 'plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings. The IgG3 method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G subclass 3 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 3 aid in the diagnosis of plasma cell antibody forming abnormalities in conjunction with clinical and other laboratory findings. The IgG4 method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G subclass 4 in human serum, heparinized plasma and EDTA plasma on the Dimension Vista® System. Measurements of immunoglobulin G subclass 4 aid in the diagnosis of plasma cell antibody formning abnormnalities in conjunction with clinical and other laboratory findings.

Source page: https://510kreport.com/device/K092283
Methodology: https://510kreport.com/methodology