510(k) · Cleared
ClearedRoche Total Mycophenolic Acid Assay, Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · OAV Mycophenolic Acid Test System
Cleared on Feb 16, 2007 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Feb 16, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- OAV
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK063520 Roche Total Mycophenolic Acid Assay, Calibrators and ControlsRoche Diagnostics · 2007
- Descendant · cites it directly · 0 of its ownK102772 Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension…Siemens Heatlhcare Diagnostics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK081083 Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid…Thermo Fisher Scientific · 2008
Most influential descendants
Showing 2 of 2 · See all- K102772Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid…Siemens Heatlhcare Diagnostics, Inc. · 2011 · cites it directly0descendants
- K081083Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid ControlsThermo Fisher Scientific · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063520 | Roche Total Mycophenolic Acid Assay, Calibrators and Controls | Roche Diagnostics | 2007 | — |
| +1 | K102772 | Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension… | Siemens Heatlhcare Diagnostics, Inc. | 2011 | — |
| +1 | K081083 | Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls | Thermo Fisher Scientific | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K102772 (Siemens Heatlhcare Diagnostics, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OAV devicesOAV Mycophenolic Acid Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 | — |
https://510kreport.com/device/K063520 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063520: Roche Total Mycophenolic Acid Assay, Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063520
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026