# K110616: Thermo Scientific Mas Omni-Immune,  Mas Omni Immune Pro

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jun 29, 2011 after 118 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891475 (1989). 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)
- K981532: Lyphochek Immunoassay Plus Control, Bio-Rad (1998) Summary page 2.

## Recalls of this device
- Dec 2, 2013 · Class III · Z-1929-2014: The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
- Dec 2, 2013 · Class III · Z-1930-2014: The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change.
- Aug 20, 2012 · Class III · Z-0379-2013: In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability.

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

Source page: https://510kreport.com/device/K110616
Methodology: https://510kreport.com/methodology