510(k) · Cleared
ClearedAbbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · KLT Enzyme Immunoassay, Carbamazepine
Cleared on Jan 27, 2000 as substantially equivalent to K913066 (Syva Co., 1991) after a 140-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Jan 27, 2000
- Review
- 140 days
- Class
- Class II
- Product code
- KLT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913066 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK913066 Emit (R) 2000 Carbamazepine Assay/CalibratorsSyva Co. · 1991
- This deviceK993028 Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and…Syva Co. · 2000
- Descendant · cites it directly · 0 of its ownK123518 Abbott Carbamazepine AssayMicrogenics Corporation · 2013
Most influential descendants
Showing 1 of 1 · See all- K123518Abbott Carbamazepine AssayMicrogenics Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913066 | Emit (R) 2000 Carbamazepine Assay/Calibrators | Syva Co. | 1991 | — |
| 0 (this device) | K993028 | Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90 | Syva Co. | 2000 | — |
| +1 | K123518 | Abbott Carbamazepine Assay | Microgenics Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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 |
|---|---|---|---|
| * | K913066 | Emit (R) 2000 Carbamazepine Assay/CalibratorsSummary page 1…n human serum or plasma. The Abbott Aeroset® Carbamazepine Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Carbamazepine Assay (K913066) with regard to intended use, assay sample, and overall performance characteristics. 28 510kabbtcarb.doc 510(k)… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123518 | Abbott Carbamazepine Assay | 2013 | 0 |
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.
- Of its descendants, K123518 (Microgenics Corporation, 2013) has gone furthest, with 0 descendants of its own.
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 Abbott Aeroset® Carbamazepine Assay is a8 homogeneous enzyme immunoassay intended for use in the quantitative analysis of carbamazepine in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum carbamazepine concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the…
Read the full statement (164 words)
The Abbott Aeroset® Carbamazepine Assay is a8 homogeneous enzyme immunoassay intended for use in the quantitative analysis of carbamazepine in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum carbamazepine concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the following reasons (1, 2):
« Serum carbamazepine concentrations correlate better with pharmacologic activity than does dosage.
o Changes in carbamazepine's half-life with prolonged treatment and interindividual differences in carbamazepine metabolism make it difficult to predict serum levels from the administered dosage, particularly during concomitant therapy with other anticonvulsants. Serum level monitoring helps physicans individualize dosage regimens.
e Carbamazepine is safe and effective only in a narrow range of serum concentrations.
Carbamazepine-10,11-epoxide, a major metabolite of carbamazepine, is pharmacologically active and found in plasma and tissues (3).
Methods historically used to monitor serum carbamazepine concentrations include gas-liquid chromatography, high-performance liquid chromatographfiglimmunoassay (1,2,4,5).
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/K993028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993028: Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993028
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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