510(k) · Cleared
ClearedDimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid Calibrator (Mpat Cal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Heatlhcare Diagnostics, Inc. · OAV Mycophenolic Acid Test System
Cleared on Oct 7, 2011 as substantially equivalent to K063520 (Roche Diagnostics, 2007) after a 378-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Oct 7, 2011
- Review
- 378 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 deviceK102772 Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension…Siemens Heatlhcare Diagnostics, Inc. · 2011
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) | K102772 | Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension… | Siemens Heatlhcare Diagnostics, Inc. | 2011 | — |
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…Class Code Dimension" MPAT Roche Total MPA assay for 2 F Flex® Reagent the COBAS INTEGRA K063520 if 823840R OAV Carti system 8234 Dimen… | 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. 2011, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102772: Dimension Mycophenolic Acid (Mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid Calibrator (Mpat Cal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102772
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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