# K964068: Carbamazepine Assay for the Technicon Immuno 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 13, 1996 after 64 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) Syva EMIT® 2000 Carbamazepine Assay: named in the summary without a submission number

## Indications for use
This in vitro method is intended to quantitatively meagure carbamazepine, an anti-convulsant drug, in human serum or plasma (beparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-1° system. Measurements of carbamazepine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy.

Source page: https://510kreport.com/device/K964068
Methodology: https://510kreport.com/methodology