# K012777: Acs: 180 and Advia Centaur Anti-Thyroglobulin Immunoassays

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Oct 22, 2001 after 63 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952130 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992790: Brahms Diagnostica Dynotest Anti-TG, Brahms Diagnostica, LLC (1999) Summary page 1.

## Recalls of this device
- Dec 7, 2018 · Class II · Z-1234-2019: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organ
- Dec 7, 2018 · Class II · Z-1233-2019: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organ
- Dec 7, 2018 · Class II · Z-1236-2019: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organ
- Dec 7, 2018 · Class II · Z-1235-2019: Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organ

## Indications for use
The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of autoantibodies against thyroglobulin (TG) in human serum and plasma for use on the automated analyzer marketed by Bayer Corporation. The ACS:180 and ADVIA Centaur anti-Tg Immunoassays are used as an aid in the diagnosis of Hashimoto’s and Graves’ disease, autoimmune diseases affecting the thyroid gland.

Source page: https://510kreport.com/device/K012777
Methodology: https://510kreport.com/methodology