# K102772: Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid Calibrator (Mpat Cal)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Heatlhcare Diagnostics, Inc.
- Decided: Oct 7, 2011 after 378 days
- Product code: OAV (Mycophenolic Acid Test System)
- Device class: 2
- Regulation: 21 CFR 862.3840
- 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 K063520 (2007). 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)
- K063520: Roche Total Mycophenolic Acid Assay, Calibrators and Controls, Roche Diagnostics (2007) Summary page 1.

## Indications for use
The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients. The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K102772
Methodology: https://510kreport.com/methodology