510(k) · Cleared
Recalled · 2008Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · DIP Enzyme Immunoassay, Diphenylhydantoin
Cleared on Jan 27, 2000 as substantially equivalent to K913429 (Syva Co., 1991) after a 140-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Jan 27, 2000
- Review
- 140 days
- Class
- Class II
- Product code
- DIP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913429 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK913429 Emit (R) 2000 Phenytoin Assay/CalibratorsSyva Co. · 1991
- This deviceK993026 Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin CalibratorsSyva Co. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913429 | Emit (R) 2000 Phenytoin Assay/Calibrators | Syva Co. | 1991 | — |
| 0 (this device) | K993026 | Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin Calibrators | Syva Co. | 2000 | — |
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 |
|---|---|---|---|
| * | K913429 | Emit (R) 2000 Phenytoin Assay/CalibratorsSummary page 1…nytoin in human serum or plasma. The Abbott Aeroset® Phenytoin Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Phenytoin Assay (K913429) with regard to intended use, assay sample, and overall performance characteristics. ' 28 510kabbtpheny.doc 510… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 15, 2008 | Not classified | Z-2059-2008 | Other | An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. In addition, the 14 day calibration interval is also not being met. Further… |
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.
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 Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenytoin in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenytoin concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anti-convulsant medication for the following…
Read the full statement (158 words)
The Abbott Aeroset® Phenytoin Assay is a homogeneous enzyme immunoassay intended for
use in the quantitative analysis of phenytoin in human serum or plasma on the Abbott Aeroset®
analyzer (K980367). Monitoring serum phenytoin concentrations, along with careful clinical
assessment, is the most effective means of improving seizure control, reducing the risk of
toxicity, and minimizing the need for additional anti-convulsant medication for the following
reasons:
« Serum phenytoin concentrations correlate better with pharmacologic activity than does
dosage because of individual differences in absorption, metabolism, disease states,
concomitant medication, and compliance. Serum concentration monitoring helps physicans
individualize dosage regimens.
o The hepatic enzyme system for metabolizing phenytoin can become saturated within the
drug's therapeutic range. When this occurs, small dosage alterations can lead to
unexpected drug accumulation and clinical toxicity.
» Phenytoin is safe and effective only in a narrow range of serum concentrations.
o Methods historically used to monitor serum phenytoin concentrations include
‘wat raphic assays and immunoassays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993026: Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993026
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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