510(k) · Cleared
ClearedDimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H
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 Aug 24, 2006 as substantially equivalent to K042735 (Dade Behring, Inc., 2005) and 2 other predicates after a 56-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 24, 2006
- Review
- 56 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). No later device cites it as a predicate yet.
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) | K061845 | Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and… | Dade Behring, Inc. | 2006 | — |
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 |
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 1…Panel: Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring NAntisera to Human IgM - K042735 Dade Behring N Protein Standard SL - K01 2470 Dade Behring N/T Protein Control SL - K01 2468 4.… | 2005 |
| * | K012470 | Modification to N Protein Standard SLSummary page 1…Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring NAntisera to Human IgM - K042735 Dade Behring N Protein Standard SL - K01 2470 Dade Behring N/T Protein Control SL - K01 2468 4. Device Description: Dimension Vista TM IGM Fl… | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 1…arketed Device: Dade Behring NAntisera to Human IgM - K042735 Dade Behring N Protein Standard SL - K01 2470 Dade Behring N/T Protein Control SL - K01 2468 4. Device Description: Dimension Vista TM IGM Flex® reagent cartridge Proteins contained in human… | 2001 |
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 6 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 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?
Dimension VistaTM IGM Flex® reagent cartridge: The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. Dimension VistaTM Protein I Calibrator Protein 1 Calibrator is an in vitro diagnostic product for the…
Read the full statement (137 words)
Dimension VistaTM IGM Flex® reagent cartridge:
The IgM method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin M in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of IgM aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension VistaTM Protein I Calibrator
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension VistaTM System.
Dimension VistaTM Protein I Control L, M and H
Protein 1 Control L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) on the Dimension Vista m System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061845: Dimension Vista Igm Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061845
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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