510(k) · Cleared
ClearedDimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator
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 Feb 26, 2008 as substantially equivalent to K042735 (Dade Behring, Inc., 2005) and 3 other predicates after a 69-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Feb 26, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K002852 (2000). 31 ancestors in all, the oldest K860021 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
- 5 generations backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
- 4 generations backK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
- 3 generations backK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
- 2 generations backK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
- 1 generation backK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
- This deviceK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK081161 Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −5 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| −4 | K061338 | Dimension Vista Iga Flex Reagent Cartridge Assay | Dade Behring, Inc. | 2006 | — |
| −3 | 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 | — |
| −1 | K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1… | Dade Behring, Inc. | 2007 | — |
| 0 (this device) | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
| +1 | K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System… | Dade Behring, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (4)
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 3…nd comparison information: The NAntisera to Human Immunoglobulins (IgG, IgA, and IgM) was determined to be substantially equivalent in 510(k) Premarket Notification k042735 and is the predicate for adding the CSF sample matrix to the Dimension Vista® IGG assay. The current Dimension Vista® IGG Fl… | 2005 |
| * | K051087 | Dimension Vista Integrated SystemSummary page 3…Vista® IGG assay. The current Dimension Vista® IGG Flex® reagent cartridge was originally determined to be substantially equivalent in 510(k) Premarket Notification k051087. The subsequent assay modifications are described in this submission. The changes include: adjustment of the measuring range;… | 2005 |
| * | K071980 | Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HSummary page 1…to Human Immunoglobulins (lgG, IgA, and IgM) k<042735 Dimension Vista® System Immunoglobulin G Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator (k071980) Dimension Vista® System Protein 3 Control (k072435) 4. Device Descriptions: Dimension Vista® System Immunoglobulin G Flex… | 2007 |
| * | K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HSummary page 1…Dimension Vista® System Immunoglobulin G Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator (k071980) Dimension Vista® System Protein 3 Control (k072435) 4. Device Descriptions: Dimension Vista® System Immunoglobulin G Flex® reagent cartridge Proteins contained in human body… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081161 | Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1… | 2008 | 0 |
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 8 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 6 of the 31 ancestors have a recall of any class.
- Of its descendants, K081161 (Dade Behring, Inc., 2008) has gone furthest, with 0 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. 2008, 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?
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α1-Acid Glycoprotein (AlAG)…
Read the full statement (181 words)
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma and cerebrospinal fluid (CSF) on the Dimension Vista System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:
α1-Acid Glycoprotein (AlAG) Immunoglobulin G (IGG) [serum/plasma]
and Immunoglobulin G (IGG-C)
[cerebrospinal fluid]
α1-Antitrypsin (AlAT) Immunoglobulin G Subclass 1 (IGG1)
β2-Microglobulin (B2MIC) Immunoglobulin G Subclass 2 (IGG2)
C3 Complement (C3) Immunoglobulin G Subclass 3 (IGG3)
C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4)
Ceruloplasmin (CER) Immunoglobulin M (IGM)
Haptoglobin (HAPT) Prealbumin (PREALB)
Hemopexin (HPX) Retinol Binding Protein (RBP)
Homocysteine (HCYS) soluble Transferrin Receptor (STFR)
Immunoglobulin A (IGA) Transferrin (TRF)
Immunoglobulin E (IGE)
PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of α1-Microglobulin (A1MIC), specialty Albumin (sALB)*, Immunoglobulin G (IGG-C)* and Microalbumin (MALB).
*For Cerebrospinal fluid (CSF)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073561
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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