510(k) · Cleared
Recalled · Class II · 2023Advia Centaur and Acs: 180 Folate Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · CGN Acid, Folic, Radioimmunoassay
Cleared on Feb 5, 2001 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 14 times.
- Decided
- Feb 5, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- CGN
- Recalls
- 14
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK010050 Advia Centaur and Acs: 180 Folate ImmunoassayBayer Diagnostics Corp. · 2001
- Descendant · cites it directly · 4 of its ownK071224 Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and…Dade Behring, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK121994 Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension…Siemens Healthcare Diagnostics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK172201 Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK133512 Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia…Siemens Healthcare Diagnostics · 2014
- Descendant · 2 generations on · 0 of its ownK093645 Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc. · 2007 · cites it directly4descendants
- K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc. · 2012 · 2 generations on1descendant
- K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc. · 2018 · cites it directly0descendants
- K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics · 2014 · 3 generations on0descendants
- K093645Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010050 | Advia Centaur and Acs: 180 Folate Immunoassay | Bayer Diagnostics Corp. | 2001 | — |
| +1 | K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4… | Dade Behring, Inc. | 2007 | 1 |
| +2 | K121994 | Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista… | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| +1 | K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | 2018 | 3 |
| +3 | K133512 | Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem… | Siemens Healthcare Diagnostics | 2014 | — |
| +2 | K093645 | Exl Anem Cal, Model RC640 | Siemens Healthcare Diagnostics | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGN? 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 CGN device
- #1 K233060 Elecsys Folate IIIscore 9.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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 |
|---|---|---|---|---|
| Jan 9, 2023 | Class II | Z-1152-2023 | Under Investigation by firm | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| Jan 9, 2023 | Class II | Z-1153-2023 | Under Investigation by firm | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| Jan 9, 2023 | Class II | Z-1154-2023 | Under Investigation by firm | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| Jul 22, 2019 | Class II | Z-0831-2020 | Device Design | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| Jul 22, 2019 | Class II | Z-0829-2020 | Device Design | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| Jul 22, 2019 | Class II | Z-0830-2020 | Device Design | Homocysteine Assay May Cause Elevated Results in the Folate Assay |
| Jan 2, 2018 | Class II | Z-1689-2018 | Error in labeling | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the… |
| Jul 27, 2015 | Class II | Z-2739-2015 | Process design | Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay. |
| Mar 25, 2014 | Class II | Z-1564-2014 | Nonconforming Material/Component | Serum controls may go out of range low with the ADVIA Centaur ¿Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223 |
| Jul 25, 2013 | Class II | Z-2172-2013 | Material/Component Contamination | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. |
| Jul 25, 2013 | Class II | Z-2170-2013 | Material/Component Contamination | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. |
| Jul 25, 2013 | Class II | Z-2171-2013 | Material/Component Contamination | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. |
| Jul 25, 2013 | Class II | Z-2169-2013 | Material/Component Contamination | Calibration failures and/or significant negative shifts in quality control (QC) and patient results. |
| Nov 14, 2012 | Class II | Z-0511-2013 | Device Design | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071224 (Dade Behring, Inc., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGN
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGN
Too few CGN 510(k)s in any year since 2007 to give a median.
Recalls per year · CGN
3in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGN
9in 2025
MAUDE reports naming product code CGN, 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 | — | 2 | 26 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 28 |
| 2012 | 0 | — | 2 | 11 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 2 | 2 |
| 2019 | 0 | — | 3 | 1 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010050: Advia Centaur and Acs: 180 Folate Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010050
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026