510(k) · Cleared
ClearedPhenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Electron OY · DIP Enzyme Immunoassay, Diphenylhydantoin
Cleared on Oct 17, 2007 after a 366-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 17, 2007
- Review
- 366 days
- Class
- Class II
- Product code
- DIP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DIP? 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 |
|---|---|---|---|
| * | — | CEDIA® Phenytoin II Named without a submission number |
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.
How does its category compare?
All DIP devicesDIP Enzyme Immunoassay, Diphenylhydantoin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DIP
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · DIP
Too few DIP 510(k)s in any year since 2007 to give a median.
Recalls per year · DIP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIP
2in 2025
MAUDE reports naming product code DIP, 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 | 2 |
| 2008 | 1 | — | 1 | 20 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 59 |
| 2011 | 0 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 51 |
| 2013 | 0 | — | 3 | 163 |
| 2014 | 0 | — | 2 | 57 |
| 2015 | 0 | — | 0 | 65 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 0 | — | 1 | 55 |
| 2018 | 0 | — | 0 | 79 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 42 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Phenytoin is intended for quantitative in vitro diagnostic determination of the phenytoin concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to help ensure proper therapy.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981647 Phenytoin assay on T60 Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063145: Phenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063145
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026