510(k) · Cleared
ClearedDimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control
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 Oct 4, 2006 as substantially equivalent to K032535 (Roche Diagnostics Corp., 2003) and 2 other predicates after a 77-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Oct 4, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002609 (2000). 4 ancestors in all, the oldest K962373 (1996). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002609 Tina-Quant Rheumatoid Factors II Test SystemRoche Diagnostics Corp. · 2000 · Recalled
- 1 generation backK032535 Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II…Roche Diagnostics Corp. · 2003
- This deviceK062035 Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK072435 Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1…Dade Behring, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK083445 N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK233663 N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · cites it directly5descendants
- K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007 · 2 generations on4descendants
- K083445N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LCSiemens Healthcare Diagnostics · 2009 · 3 generations on1descendant
- K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 3 generations on1descendant
- K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002609 | Tina-Quant Rheumatoid Factors II Test System | Roche Diagnostics Corp. | 2000 | 1 |
| −1 | K032535 | Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test System | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K062035 | Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control | Dade Behring, Inc. | 2006 | — |
| +1 | 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 | — |
| +3 | K083445 | N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control… | Siemens Healthcare Diagnostics | 2009 | 2 |
| +3 | K073561 | Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension… | Dade Behring, Inc. | 2008 | — |
| +4 | K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | Siemens Healthcare Diagnostics Products GmbH | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K032535 | Modification to:Roche Diagnostics Tina-Quant Rheumatoid Factors II Test SystemSummary page 1…Panel: Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: ROCHE Tina-Quant RF IIassay - K032535 N Rheumatology Standard SL - K964527 N/T Rheumatology Control SL - K962373 4. Device Description:… | 2003 |
| * | K964527 | N Rheumatology Standard SLSummary page 1…Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: ROCHE Tina-Quant RF IIassay - K032535 N Rheumatology Standard SL - K964527 N/T Rheumatology Control SL - K962373 4. Device Description: Dimension VistaTM RF Flex® reagent cartri… | 1997 |
| * | K962373 | N/T Rheumatology Control SL/1 and SL/2Summary page 1…on of the Legally Marketed Device: ROCHE Tina-Quant RF IIassay - K032535 N Rheumatology Standard SL - K964527 N/T Rheumatology Control SL - K962373 4. Device Description: Dimension VistaTM RF Flex® reagent cartridge Polystyrene particles coated with… | 1996 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063508 | Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and… | 2007 | 5 |
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 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K063508 (Dade Behring, Inc., 2007) has gone furthest, with 5 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.
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?
The RF method is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum and lithium heparin plasma on the Dimension VistaTM System. Measurements of RF are used as an aid in the diagnosis of rheumatoid arthritis.
PROT2 CAL is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP), high sensitivity CRP (hsCRP) and Rheumatoid Factors (RF) methods on the Dimension VistaTM System.
PROT2 CON L and H are assayed intralaboratory quality controls for the assessment of precision and analytical bias in the determination of C-reactive protein (CRP) and Rheumatoid Factor (RF) on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062035: Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062035
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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