510(k) · Cleared
ClearedAce Primidone Reagent, Aed Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · DJD Enzyme Immunoassay, Primidone
Cleared on Nov 12, 1997 as substantially equivalent to K960526 (Diagnostic Reagents, Inc., 1996) after a 51-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 12, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- DJD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960526 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK960526 Primidone Eia TestDiagnostic Reagents, Inc. · 1996
- This deviceK973582 Ace Primidone 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 | K960526 | Primidone Eia Test | Diagnostic Reagents, Inc. | 1996 | — |
| 0 (this device) | K973582 | Ace Primidone 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 DJD? 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 |
|---|---|---|---|
| * | K960526 | Primidone Eia TestSummary page 1…Common Name: Enzyme immunoassay for primidone Classification Name: Primidone test Predicate Device: Diagnostic Reagents, Inc. (DRI) - Primidone Reagent [510(k) Number K960526] Device Description The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate rea… | 1996 |
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 DJD devicesDJD Enzyme Immunoassay, Primidone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJD
FDA has decided no DJD device since 2007.
Median 510(k) review, days · DJD
Too few DJD 510(k)s in any year since 2007 to give a median.
Recalls per year · DJD
No recall names DJD since 2007.
Adverse event reports per year · DJD
No MAUDE report names DJD since 2007.
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 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 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 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ACE® Primidone Reagent is intended for the quantitative determination of
primidone in serum using the ACE® clinical chemistry analyzer.
Primidone (Mysoline®) used alone, or in combination with other anti-
convulsants, is indicated in the control of grand mal, psychomotor, and focal
epileptic seizures. In combination with other clinical data, monitoring serum
primidone levels will provide physicians with useful information to aid in
adjusting patient dosage to achieve optimal therapeutic effect while avoiding
drug toxicity.
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/K973582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973582: Ace Primidone Reagent, Aed Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973582
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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