510(k) · Cleared
ClearedDimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst
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 28, 2008 as substantially equivalent to K951635 (Beckman Instruments, Inc., 1995) and 2 other predicates after a 95-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Jul 28, 2008
- Review
- 95 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K002852 (2000). 33 ancestors in all, the oldest K860021 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
- 6 generations backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
- 5 generations backK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
- 4 generations backK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
- 3 generations backK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
- 2 generations backK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
- 1 generation backK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
- This deviceK081161 Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −6 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| −5 | K061338 | Dimension Vista Iga Flex Reagent Cartridge Assay | Dade Behring, Inc. | 2006 | — |
| −4 | K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High | Dade Behring, Inc. | 2006 | — |
| −3 | K063508 | Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator… | Dade Behring, Inc. | 2007 | — |
| −2 | K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1… | Dade Behring, Inc. | 2007 | — |
| −1 | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
| 0 (this device) | 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 |
| 1995 | 1 | 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 |
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 |
|---|---|---|---|
| * | K951635 | Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator…Summary page 1…Dimension Vista® System Protein 3 Control 3. Identification of the Legally marketed Device: Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G (k951635) N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (k042735) Dimension Vista® System Protein 1 Calibrator (k073561) D… | 1995 |
| * | K042735 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Summary page 1…the Legally marketed Device: Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G (k951635) N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (k042735) Dimension Vista® System Protein 1 Calibrator (k073561) Dimension Vista® System Protein 3 Control (k073561) 4. Device Descr… | 2005 |
| * | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Summary page 1…munochemistry System Urine Immunoglobulin G (k951635) N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (k042735) Dimension Vista® System Protein 1 Calibrator (k073561) Dimension Vista® System Protein 3 Control (k073561) 4. Device Descriptions: Dimension Vista®System Immunoglobulin G Flex®r… | 2008 |
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 8 years and passes through 1 company; a new generation was cleared every 6 months on median.
- 6 of the 33 ancestors have a recall of any class.
- 2 other devices also cite its predicate K951635.
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?
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 a - Microglobulin (AlMIC), specialty Albumin (sALB)*, Immunoglobulin G (IGG -C)*, Immunoglobulin G (IGG-U)** and Microalbumin (MALB). * For Cerebrospinal fluid (CSF) ** For urine PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a4-Acid…
Read the full statement (197 words)
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 a - Microglobulin (AlMIC), specialty Albumin (sALB)*, Immunoglobulin G (IGG -C)*, Immunoglobulin G (IGG-U)** and Microalbumin (MALB).
* For Cerebrospinal fluid (CSF)
** For urine
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:
a4-Acid Glycoprotein (A1AG) Immunoglobulin G (IGG) [serum/plasmal, Immunoglobulin G (IGG-C) [cerebrospinal fluid] and Immunoglobulin G (1IGG-U) [urine]
as-Antitrypsin (A1AT) Immunoglobulin G Subclass 1 (1IGG1)
B2-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)
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma, cerebrospinal fluid (CSF) and urine 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081161: Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081161
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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