# K993571: Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 16, 1999 after 56 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: none
- 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; 1 cites 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. The FDA summary names its predicate without a number.
- (no number) ACS:180 VB12: named in the summary without a submission number
- (no number) ADVIA Centaur VB12: named in the summary without a submission number

## Most influential descendants
- K030655: Holotc Ria (2004), 6 descendants of its own
- K062467: Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01; Control Kit, Model 3L83-10 (2006), 5 descendants of its own
- K112443: Architect Active B-12 (Holotranscobalamin) (2011), 4 descendants of its own
- K160757: ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (2016), 1 descendant of its own
- K233541: ARCHITECT Active-B12 (Holotranscobalamin) (2024), 0 descendants of its own

## Indications for use
In vitro diagnostic use in the quantitative determination of vitamin B12 in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur System.

Source page: https://510kreport.com/device/K993571
Methodology: https://510kreport.com/methodology