510(k) · Cleared
ClearedAce Carbamazepine Reagent/Aed Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · KLT Enzyme Immunoassay, Carbamazepine
Cleared on Oct 20, 1997 as substantially equivalent to K955100 (Diagnostic Reagents, Inc., 1995) after a 32-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Oct 20, 1997
- Review
- 32 days
- Class
- Class II
- Product code
- KLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955100 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK955100 Carbamazepine Eia TestDiagnostic Reagents, Inc. · 1995
- This deviceK973535 Ace Carbamazepine 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 | K955100 | Carbamazepine Eia Test | Diagnostic Reagents, Inc. | 1995 | — |
| 0 (this device) | K973535 | Ace Carbamazepine 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 KLT? 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 |
|---|---|---|---|
| * | K955100 | Carbamazepine Eia TestSummary page 1…unoassay for carbamazepine (Tegretol”) Classification Name: Carbamazepine test Predicate Device: Diagnostic Reagents, Inc. (DRI) - Carbamazepine Reagent [510(k) Number K955100] Device Description The ACE® Carbamazepine 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 KLT devicesKLT Enzyme Immunoassay, Carbamazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KLT
Too few KLT 510(k)s in any year since 2007 to give a median.
Recalls per year · KLT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLT
4in 2025
MAUDE reports naming product code KLT, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ACE® Carbamazepine Reagent is intended for the quantitative determination
of carbamazepine in serum using the ACE® clinical chemistry analyzer.
Carbamazepine is an anticonvulsant drug, used in particular for the treatment
of trigeminal neuralgia, all forms of partial epilepsy, generalized tonic-clonic
seizures, and simple and complex partial seizures. The specific mechanism of
carbamazepine is proposed as a depressant action on transmission through the
nucleus ventralis anterior of the thalamus.
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/K973535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973535: Ace Carbamazepine 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/K973535
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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