510(k) · Cleared
Recalled · Class II · 2012Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · CDD Radioassay, Vitamin B12
Cleared on Nov 13, 2007 as substantially equivalent to K041133 (Bayer Healthcare, LLC, 2004) and 2 other predicates after a 195-day review. Its family tree reaches back 4 generations to 1990. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 2007
- Review
- 195 days
- Class
- Class II
- Product code
- CDD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902336 (1990). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- 3 generations backK971418 Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur…Chiron Diagnostics Corp. · 1997 · Recalled
- 2 generations backK032525 Bayer Advia Centaur Automated Chemiluminescence AnalyzerBayer Healthcare, LLC · 2003
- 1 generation backK041133 Modification to Bayer Advia Centaur Automated Chemiluminescence…Bayer Healthcare, LLC · 2004 · Recalled
- This deviceK071224 Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and…Dade Behring, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK121994 Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension…Siemens Healthcare Diagnostics, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK133512 Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia…Siemens Healthcare Diagnostics · 2014
- Descendant · cites it directly · 0 of its ownK093645 Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics · 2010
- Descendant · cites it directly · 0 of its ownK093631 B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642…Siemens Healthcare Diagnostics · 2010
Most influential descendants
Showing 4 of 4 · See all- K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc. · 2012 · cites it directly1descendant
- K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics · 2014 · 2 generations on0descendants
- K093645Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics · 2010 · cites it directly0descendants
- K093631B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644Siemens Healthcare Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| −3 | K971418 | Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer | Chiron Diagnostics Corp. | 1997 | 4 |
| −2 | K032525 | Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2003 | — |
| −1 | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer | Bayer Healthcare, LLC | 2004 | 8 |
| 0 (this device) | K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4… | Dade Behring, Inc. | 2007 | — |
| +1 | K121994 | Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista… | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| +2 | K133512 | Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem… | Siemens Healthcare Diagnostics | 2014 | — |
| +1 | K093645 | Exl Anem Cal, Model RC640 | Siemens Healthcare Diagnostics | 2010 | — |
| +1 | K093631 | B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644 | Siemens Healthcare Diagnostics | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 CDD? 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 CDD device
- #1 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 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 |
|---|---|---|---|
| * | K041133 | Modification to Bayer Advia Centaur Automated Chemiluminescence AnalyzerSummary page 1…Product Device number Class Code B 12 Flex® reagent cartridge for VB 12 for the ADVIA K041133 II 862.1810 CDD the Dimension Vista® system Centaur® System FOL Flex® reagent cartridge foJ FOL for the ADVIA… | 2004 |
| * | K010050 | Advia Centaur and Acs: 180 Folate ImmunoassaySummary page 1…the ADVIA K041133 II 862.1810 CDD the Dimension Vista® system Centaur® System FOL Flex® reagent cartridge foJ FOL for the ADVIA K010050 Ii 862.1295 CGN the Dimension Vista® system Centaur® system LOCI 4 Calibrator for the FERR Calibrator fo… | 2001 |
| * | K983548 | Ferritin CalibratorSummary page 1…e ADVIA K010050 Ii 862.1295 CGN the Dimension Vista® system Centaur® system LOCI 4 Calibrator for the FERR Calibrator for the K983548 II 862.1150 JDX Dimension Vista® system Dimension system Device Description: B12 The Dimension Vista®… | 1998 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2012 | Class II | Z-1869-2012 | Device Design | Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antibody in some patients can result in a false and significant elevation in the reported concentration of Vitamin B12 on the Dimension Vista… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K121994 (Siemens Healthcare Diagnostics, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K041133.
How does its category compare?
All CDD devicesCDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CDD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CDD
147in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CDD
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDD
44in 2025
MAUDE reports naming product code CDD, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 36 |
| 2012 | 3 | 147 | 0 | 23 |
| 2013 | 1 | — | 0 | 45 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 9 |
| 2018 | 0 | — | 2 | 15 |
| 2019 | 2 | — | 1 | 14 |
| 2020 | 0 | — | 0 | 11 |
| 2021 | 0 | — | 1 | 28 |
| 2022 | 1 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The B12 Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The FOL Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension Vista® system.…
Read the full statement (116 words)
The B12 Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The FOL Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of folate in human serum and plasma on the Dimension Vista® system. Measurements obtained by this device are used in the diagnosis and treatment of megaloblastic anemia.
The LOCI 4 Calibrator is an in vitro diagnostic product for the calibration of Ferritin (FERR), Vitamin B 12 (B12), and Folate (FOL) methods on the Dimension Vista® system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071224 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071224
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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