# K042808: Advia Ims Carbamazepine Method

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Feb 8, 2005 after 119 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bayer Centaur: named in the summary without a submission number

## Indications for use
The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to measure the antiepileptic drug carbamazepine in human serum and plasma. Measurements of carbamazepine (5H-Dibenz[b,f]azepine-5-carboxamide) are used as an aid in the diagnosis and treatment of carbamazepine overdose, in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy. The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.

Source page: https://510kreport.com/device/K042808
Methodology: https://510kreport.com/methodology