# K122291: Thermo Scientific Mas Omni-Cardio

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Aug 31, 2012 after 31 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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 K040880 (2004). 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)
- K040880: Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3, Medical Analysis Systems, Inc. (2004) Summary page 1.
- K061196: Cardioimmune XL Cardiac Marker Control, Microgenics Corp. (2006) Summary page 1.

## Indications for use
MAS® Omni-CARDIO Thermo Scientific MAS® Omni*CARDlOI is intended for use in the clinical. laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.

Source page: https://510kreport.com/device/K122291
Methodology: https://510kreport.com/methodology