# K973535: Ace Carbamazepine Reagent/Aed Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Oct 20, 1997 after 32 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 K955100 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955100: Carbamazepine Eia Test, Diagnostic Reagents, Inc. (1995) Summary page 1.

## Indications for use
ACE® Carbamazepine Reagent is intended for the quantitative determination of carbamazepine in serum using the ACE® clinical chemistry analyzer. Carbamazepine is an anticonvulsant drug, used in particular for the treatment of trigeminal neuralgia, all forms of partial epilepsy, generalized tonic-clonic seizures, and simple and complex partial seizures. The specific mechanism of carbamazepine is proposed as a depressant action on transmission through the nucleus ventralis anterior of the thalamus.

Source page: https://510kreport.com/device/K973535
Methodology: https://510kreport.com/methodology