510(k) · Cleared
ClearedRandox Carbamazepine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · KLT Enzyme Immunoassay, Carbamazepine
Cleared on Jan 15, 2002 after a 231-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 15, 2002
- Review
- 231 days
- Class
- Class II
- Product code
- KLT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with carbamazepine which, in the presence of carbamazepine antibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the…
Read the full statement (175 words)
The Randox Laboratories Ltd. Carbamazepine Test Kit is an in vitro diagnostic reagent for the quantitative determination of carbamazepine in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with carbamazepine which, in the presence of carbamazepine antibody solution, rapidly agglutinate. When a sample containing carbamazepine is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of carbamazepine in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of carbamazepine in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine use or overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.
These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011648: Randox Carbamazepine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011648
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026