# K993028: Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jan 27, 2000 after 140 days
- Product code: KLT (Enzyme Immunoassay, Carbamazepine)
- Device class: 2
- Regulation: 21 CFR 862.3645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913066 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913066: Emit (R) 2000 Carbamazepine Assay/Calibrators, Syva Co. (1991) Summary page 1.

## Most influential descendants
- K123518: Abbott Carbamazepine Assay (2013), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K993028
Methodology: https://510kreport.com/methodology