510(k) · Cleared
ClearedDimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista Immunoglobulin M Flex Reagent Cartrid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Apr 29, 2009 as substantially equivalent to K042735 (Dade Behring, Inc., 2005) after a 55-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Apr 29, 2009
- Review
- 55 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K860894 (1986). No later device cites it as a predicate yet.
- Root · 2 generations backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
- 1 generation backK042735 N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc. · 2005
- This deviceK090594 Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and…Siemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860894 | Behring Nephelometer System | Behring Diagnostics, Inc. | 1986 | — |
| −1 | K042735 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) | Dade Behring, Inc. | 2005 | — |
| 0 (this device) | K090594 | Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension… | Siemens Healthcare Diagnostics | 2009 | — |
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 CFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K042735 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Summary page 1…ode: CFN Panel: Immunology (82) 3. Identification of the Legally Marketed Device: Siemens N Antisera to Human IgA (K042735) Siemens N Antisera to Human IgM (K042735) 4. Device Description: Dimension Vista® IGA Flex® reagent car… | 2005 |
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.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K042735.
How does its category compare?
All CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (117 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090594: Dimension Vista Immunoglobulin a Flex Reagent Cartridge (Iga), and Dimension Vista Immunoglobulin M Flex Reagent Cartrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090594
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026