510(k) · Cleared
ClearedAce Phenobarbital Reagent/Aed Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · DLJ Calibrators, Drug Specific
Cleared on Nov 6, 1997 as substantially equivalent to K946210 (Diagnostic Reagents, Inc., 1995) after a 49-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 6, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946210 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK946210 Phenobarbital Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1995
- This deviceK973536 Ace Phenobarbital 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 | K946210 | Phenobarbital Enzyme Immunoassay | Diagnostic Reagents, Inc. | 1995 | — |
| 0 (this device) | K973536 | Ace Phenobarbital 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 DLJ? 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 |
|---|---|---|---|
| * | K946210 | Phenobarbital Enzyme ImmunoassaySummary page 1…: Enzyme immunoassay for phenobarbital Classification Name: Phenobarbital test Predicate Device: Diagnostic Reagents, Inc. (DRI) - Phenobarbital Reagent [510(k) Number K946210] Device Description The ACE® Phenobarbital Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate… | 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 DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DLJ
Too few DLJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ACE® Phenobarbital Reagent is intended for the quantitative determination of
phenobarbital in serum using the ACE® clinical chemistry analyzer.
Since its discovery by Hauptmann in 1912, phenobarbital has been widely
prescribed for the treatment of epilepsy, particularly for controlling focal
motor or sensory and grand mal seizures. In combination with other clinical
information, monitoring serum phenobarbital levels will provide physicians:
with an essential tool to aid in adjusting dosage and achieving optimal
therapeutic effect, while avoiding both subtherapeutic and harmful toxic drug
levels.
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/K973536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973536: Ace Phenobarbital 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/K973536
Report an extraction error
Are you the manufacturer?
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