# K030102: Advia Centaur and Acs:180 Liquid Cardiac Markers 1, 2, 3

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Jan 24, 2003 after 14 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960246 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960246: Liquid Cardiac Marker 1,2,3 Assayed, Ciba Corning Diagnostics Corp. (1996) Summary page 1.

## Indications for use
The Bayer Liquid Cardiac Markers 1, 2, 3 are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of immunochemical mass measurement test procedures for the ADVIA Centaur@ and ACS:180@ Systems.

Source page: https://510kreport.com/device/K030102
Methodology: https://510kreport.com/methodology