# K110738: Thermo Scientific Mas Omni-Core

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Nov 3, 2011 after 231 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: 2 generations back to K030942 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092051: Thermo Scientific Mas  Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model, Cha, Chu, M5155, M5158, Microgenics Corp. (2009) Summary page 1.
- K960824: Immunology Control, Medical Analysis Systems, Inc. (1996) Summary page 1.

## Indications for use
Thermo Scientific MAS® OmniCORETM is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS®9 Omni-CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument.

Source page: https://510kreport.com/device/K110738
Methodology: https://510kreport.com/methodology