# K063520: Roche Total Mycophenolic Acid Assay, Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 16, 2007 after 87 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K102772: Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid Calibrator (Mpat Cal) (2011), 0 descendants of its own
- K081083: Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K063520
Methodology: https://510kreport.com/methodology