# K010050: Advia Centaur and Acs: 180 Folate Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Feb 5, 2001 after 31 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator (2007), 4 descendants of its own
- K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator (2012), 1 descendant of its own
- K172201: Atellica IM Folate Assay (2018), 0 descendants of its own
- K133512: Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal) (2014), 0 descendants of its own
- K093645: Exl Anem Cal, Model RC640 (2010), 0 descendants of its own

## Recalls of this device
- Jan 9, 2023 · Class II · Z-1152-2023: 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: 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: 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: Homocysteine Assay May Cause Elevated Results in the Folate Assay
- Jul 22, 2019 · Class II · Z-0829-2020: Homocysteine Assay May Cause Elevated Results in the Folate Assay
- Jul 22, 2019 · Class II · Z-0830-2020: Homocysteine Assay May Cause Elevated Results in the Folate Assay
- Jan 2, 2018 · Class II · Z-1689-2018: 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 
- Jul 27, 2015 · Class II · Z-2739-2015: 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: 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: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- Jul 25, 2013 · Class II · Z-2170-2013: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- Jul 25, 2013 · Class II · Z-2171-2013: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- Jul 25, 2013 · Class II · Z-2169-2013: Calibration failures and/or significant negative shifts in quality control (QC) and patient results.
- Nov 14, 2012 · Class II · Z-0511-2013: 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 syst

Source page: https://510kreport.com/device/K010050
Methodology: https://510kreport.com/methodology