510(k) · Cleared
ClearedONLINE TDM Phenytoin - Free Phenytoin application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · MOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Cleared on Mar 30, 2023 as substantially equivalent to K952555 (Roche Diagnostic Systems, Inc., 1995) after a 69-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Mar 30, 2023
- Review
- 69 days
- Class
- Class II
- Product code
- MOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952555 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952555 Cobas-FP Application for Free Phenytoin, Cobas-FP Phenytoin…Roche Diagnostic Systems, Inc. · 1995
- This deviceK230161 ONLINE TDM Phenytoin - Free Phenytoin applicationRoche Diagnostics · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952555 | Cobas-FP Application for Free Phenytoin, Cobas-FP Phenytoin Calibrators, &… | Roche Diagnostic Systems, Inc. | 1995 | — |
| 0 (this device) | K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics | 2023 | — |
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 MOJ? 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 |
|---|---|---|---|
| * | K952555 | Cobas-FP Application for Free Phenytoin, Cobas-FP Phenytoin Calibrators, & ControlsSummary page 4…ylhydantoin test system Product Codes, MOJ, 862.3350 Regulation Numbers Predicate Devices Reagent Application for Free Phenytoin (K952555) Roche Diagnostics GmbH Mannheim, Germany: 9610126 Establishment Registration Roche Diagnostics Gm… | 1995 |
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.
How does its category compare?
All MOJ devicesMOJ Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MOJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MOJ
Too few MOJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MOJ
No recall names MOJ since 2007.
Adverse event reports per year · MOJ
1in 2011
MAUDE reports naming product code MOJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 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 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ONLINE TDM Phenytoin - Free Phenytoin application is an in vitro test for the quantitative determination of free phenytoin in human serum and plasma on cobas c systems. The determination of free phenytoin is used in monitoring levels of free phenytoin to ensure appropriate therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230161: ONLINE TDM Phenytoin - Free Phenytoin application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230161
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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