510(k) · Cleared
ClearedDimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jan 23, 2007 as substantially equivalent to K062055 (Dade Behring, Inc., 2006) and 2 other predicates after a 64-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Jan 23, 2007
- Review
- 64 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002852 (2000). 16 ancestors in all, the oldest K860894 (1986). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
- 3 generations backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
- 2 generations backK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
- 1 generation backK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
- This deviceK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK081161 Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · cites it directly4descendants
- K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 2 generations on1descendant
- K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 2 generations on1descendant
- K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023 · 3 generations on0descendants
- K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −3 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +2 | K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control… | Siemens Healthcare Diagnostics | 2009 | 2 |
| +2 | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
| +3 | K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023 | — |
| +3 | 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 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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 JIX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighSummary page 1…Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dimension Vista'TM Protein I Calibrator - K062055 Dimension Vista TM Protein 1 Control L, M, H - K062055 Dimension Vista'TM Protein 2 Calibrator - K062035… | 2006 |
| * | K062035 | Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlSummary page 1…Dimension Vista'TM Protein I Calibrator - K062055 Dimension Vista TM Protein 1 Control L, M, H - K062055 Dimension Vista'TM Protein 2 Calibrator - K062035 Dimension Vista' TM Protein 2 Control L, H - K062035 Dimension Vista'TM ProteinS3 Calibrator - K061990… | 2006 |
| * | K061990 | Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Summary page 1…Dimension Vista'TM Protein 2 Calibrator - K062035 Dimension Vista' TM Protein 2 Control L, H - K062035 Dimension Vista'TM ProteinS3 Calibrator - K061990 Dimension VistaTM ProteinS3 Control - K061 990 10… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072435 | Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H | 2007 | 4 |
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 7 years and passes through 1 company; a new generation was cleared every 9 months on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K072435 (Dade Behring, Inc., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Dimension Vista Protein 1 Calibrator Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the α1-acid glycoprotein (AIAG), C3 complement (03), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) methods on the Dimension Vista® System. Dimension Vista Protein 1 Control L, M and H Protein 1 Control L, M and H are for use as assayed intralaboratory…
Read the full statement (266 words)
Dimension Vista Protein 1 Calibrator
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the α1-acid glycoprotein (AIAG), C3 complement (03), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista Protein 1 Control L, M and H
Protein 1 Control L, M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-acid glycoprotein (AIAG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista Protein 2 Calibrator
Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP), and rheumatoid factors (RF) methods on the Dimension Vista® System.
Dimension Vista Protein 2 Control L and H
Protein 1 Control L and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL), C-reactive protein (CRP), and rheumatoid factors (RF) on the Dimension Vista® System.
Dimension Vista Protein 3 Calibrator
Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the α1-microglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.
Dimension Vista Protein 3 Control
Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of α1-microglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063508: Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and Control L, H; Protein 3 Calibrator an.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063508
Report an extraction error
Are you the manufacturer?
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