# K051074: Mas Immunosuppressant Controls

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jun 6, 2005 after 40 days
- Product code: LAS (Drug Specific Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895905 (1990). 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)
- K022041: Lyphochek Whole Blood Control, Models 561, 562, 563, Bio-Rad Laboratories, Inc. (2002) Summary page 1.

## Indications for use
The MAS Immunosuppressant Controls, consisting of levels I through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

Source page: https://510kreport.com/device/K051074
Methodology: https://510kreport.com/methodology