510(k) · Cleared
ClearedAce Phenytoin Reagent, Aed Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · DIP Enzyme Immunoassay, Diphenylhydantoin
Cleared on Nov 4, 1997 as substantially equivalent to K945725 (Diagnostic Reagents, Inc., 1995) after a 56-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 4, 1997
- Review
- 56 days
- Class
- Class II
- Product code
- DIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945725 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945725 Phenytion Eia TestDiagnostic Reagents, Inc. · 1995
- This deviceK973414 Ace Phenytoin Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945725 | Phenytion Eia Test | Diagnostic Reagents, Inc. | 1995 | — |
| 0 (this device) | K973414 | Ace Phenytoin Reagent, Aed Calibrators | Schiapparelli Biosystems, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K945725 | Phenytion Eia TestSummary page 1…for phenytoin (diphenylhydantoin or Dilantin®) Classification Name: Phenytoin test Predicate Device: Diagnostic Reagents, Inc. (DRI) - Phenytoin Reagent [510(k) Number K945725] Device Description The ACE® Phenytoin Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate rea… | 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 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?
ACE® Phenytoin Reagent is intended for the quantitative determination of
phenytoin in serum using the ACE® clinical chemistry analyzer.
Phenytoin is one of the most widely prescribed anti-convulsant drugs for the
treatment of epilepsy, particulary grand mal epilepsy (major motor), corticol
focal seizures and temporal lobe epilepsy.
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/K973414 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973414: Ace Phenytoin Reagent, Aed Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973414
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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