510(k) · Cleared
ClearedCedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · OAV Mycophenolic Acid Test System
Cleared on Dec 19, 2008 as substantially equivalent to K063520 (Roche Diagnostics, 2007) after a 247-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Dec 19, 2008
- Review
- 247 days
- Class
- Class II
- Product code
- OAV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063520 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK063520 Roche Total Mycophenolic Acid Assay, Calibrators and ControlsRoche Diagnostics · 2007
- This deviceK081083 Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid…Thermo Fisher Scientific · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063520 | Roche Total Mycophenolic Acid Assay, Calibrators and Controls | Roche Diagnostics | 2007 | — |
| 0 (this device) | K081083 | Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls | Thermo Fisher Scientific | 2008 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063520 | Roche Total Mycophenolic Acid Assay, Calibrators and ControlsSummary page 1…ed for use as assayed quality control material for validation of MPA assays LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED Roche Total Mycophenolic Acid assay (K063520) DESCRIPTION OF DEVICE The CEDIA Mycophenolic Acid Assay is a homogeneous assay based on the enzyme 0-galactosidase, which has b… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K063520.
How does its category compare?
All OAV devicesOAV Mycophenolic Acid Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OAV
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · OAV
Too few OAV 510(k)s in any year since 2007 to give a median.
Recalls per year · OAV
No recall names OAV since 2007.
Adverse event reports per year · OAV
1in 2022
MAUDE reports naming product code OAV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081083: Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081083
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026