# K081083: Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Dec 19, 2008 after 247 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 CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients. The CEDIA Mycophenolic Acid Calibrators are intended for use in the calibration of the CEDIA MPA Assay. The MAS Mycophenolic Acid Controls are intended for use as assayed quality control material for validation of MPA assays

Source page: https://510kreport.com/device/K081083
Methodology: https://510kreport.com/methodology