510(k) · Cleared
ClearedDimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista Immunoglobulin Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · DFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Cleared on Oct 21, 2009 after an 84-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 21, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- DFZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DFZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Siemens N Antisera to Human IgG Subclasses 1 and 2 Named without a submission number | |
| * | — | Siemens N Latex IgG Subclasses 3 and 4 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DFZ devicesDFZ Igg (Gamma Chain Specific), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DFZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · DFZ
Too few DFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DFZ
No recall names DFZ since 2007.
Adverse event reports per year · DFZ
No MAUDE report names DFZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (220 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092283: Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista Immunoglobulin Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092283
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026