510(k) · Cleared
ClearedArchitect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DIP Enzyme Immunoassay, Diphenylhydantoin
Cleared on Sep 11, 2008 as substantially equivalent to K935375 (Abbott Laboratories, 1994) after a 183-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 11, 2008
- Review
- 183 days
- Class
- Class II
- Product code
- DIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935375 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK935375 Axsym Phenytoin AssayAbbott Laboratories · 1994
- This deviceK080696 Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators…Abbott Laboratories · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935375 | Axsym Phenytoin Assay | Abbott Laboratories | 1994 | — |
| 0 (this device) | K080696 | Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models… | Abbott Laboratories | 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 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 |
|---|---|---|---|
| * | K935375 | Axsym Phenytoin AssaySummary page 2…ce Classification: Class II Classification Panel: Toxicology Product Code: DLJ Legally marketed device to which equivalency is claimed: AxSYM Phenytoin (K935375) Intended Use of Device: The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the… | 1994 |
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 DIP devicesDIP Enzyme Immunoassay, Diphenylhydantoin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The ARCHITECT iPhenytoin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenytoin, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of phenytoin to help ensure appropriate therapy.
The ARCHITECT iPhenytoin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenytoin in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080696 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080696: Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080696
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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