510(k) · Cleared
ClearedDimension Vista Iga Flex Reagent Cartridge Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Jul 6, 2006 as substantially equivalent to K042735 (Dade Behring, Inc., 2005) and 2 other predicates after a 52-day review. Its family tree reaches back 2 generations to 2000. 7 later devices descend from it.
- Decided
- Jul 6, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002852 (2000). 6 ancestors in all, the oldest K860894 (1986). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
- 1 generation backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
- This deviceK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
- Descendant · 4 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 4 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc. · 2006 · cites it directly6descendants
- K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · 2 generations on5descendants
- K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 3 generations on4descendants
- K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 4 generations on1descendant
- K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −1 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K061338 | Dimension Vista Iga Flex Reagent Cartridge Assay | Dade Behring, Inc. | 2006 | — |
| +1 | K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High | Dade Behring, Inc. | 2006 | — |
| +2 | K063508 | Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator… | Dade Behring, Inc. | 2007 | — |
| +3 | K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1… | Dade Behring, Inc. | 2007 | — |
| +4 | K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control… | Siemens Healthcare Diagnostics | 2009 | 2 |
| +4 | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2023 | 1 | 0 |
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? (3)
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 2…1 Calibrator (K051087) and Dimension VistaTM Protein 1 Control L/M/H (K051087) are substantially equivalent to the Dade Behring N Antisera to Human IgA assay (K042735), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468) respectively. The Dimension VistaTM IGA assay, l… | 2005 |
| * | K012470 | Modification to N Protein Standard SLSummary page 2…sion VistaTM Protein 1 Control L/M/H (K051087) are substantially equivalent to the Dade Behring N Antisera to Human IgA assay (K042735), N Protein Standard SL (K012470) and N/T Protein Control SL (K012468) respectively. The Dimension VistaTM IGA assay, like the N Antisera to Human IgA assay… | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 1…rketed Device: Dade Behring NAntisera to Human IgA (K(042735) Dade Behring N Protein Standard SL (K(012470) Dade Behririg N/T Protein Control SL (K012468) 4. Device Description: Dimension Vista"" IGA Flex® reagent cartridge Proteins contained in human body fluid… | 2001 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High | 2006 | 6 |
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 6 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K062055 (Dade Behring, Inc., 2006) has gone furthest, with 6 descendants of its own.
- 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.
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?
The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
PROTI CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension VistaTM System.
For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061338 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061338: Dimension Vista Iga Flex Reagent Cartridge Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061338
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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