510(k) · Cleared
ClearedArchitect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · KLT Enzyme Immunoassay, Carbamazepine
Cleared on Oct 14, 2011 as substantially equivalent to K935374 (Abbott Laboratories, 1994) after a 305-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 14, 2011
- Review
- 305 days
- Class
- Class II
- Product code
- KLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935374 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK935374 Axsym CarbamazephineAbbott Laboratories · 1994
- This deviceK103627 Architect Icarbamazepine Icarbamazepine Reagents; Architect…Abbott Laboratories · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935374 | Axsym Carbamazephine | Abbott Laboratories | 1994 | — |
| 0 (this device) | K103627 | Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine… | Abbott Laboratories | 2011 | — |
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 |
|---|---|---|---|
| * | K935374 | Axsym CarbamazephineSummary page 2…vice Classification: Class II Classification Panel: Clinical Toxicology Code: DLJ Legally marketed device to which equivalency is claimed: AxSYM Carbamazepine (K935374) Intended Use of the Device The ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA)… | 1994 |
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. 2011, this device’s year, is highlighted.
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 ARCHITECT iCarbamazepine assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma (collected in lithium heparin, sodium heparin, dipotassium EDTA or sodium EDTA tubes) on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of carbamazepine to help ensure appropriate therapy.
The ARCHITECT iCarbamazepine Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative measurement of carbamazepine, an anticonvulsant drug, in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103627: Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103627
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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