# K153596: ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Aug 9, 2016 after 237 days
- Product code: POX (Enzyme Immunoassay, Oxcarbazepine Metabolite)
- 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: 3 generations back to K970510 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010814: Emit 2000 Carbamazepine Assay, Model OSR4F229, Syva Co., Dade Behring, Inc. (2001) Summary page 4.
- K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00, Ark Diagnostics, Inc. (2009) Summary page 4.

## Indications for use
The ARK™ Oxcarbazepine Metabolite Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of Oxcarbazepine Metabolite in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of Oxcarbazepine Metabolite to help ensure appropriate therapy. The ARK™ Oxcarbazepine Metabolite Calibrator is intended for use in calibration of the ARK Oxcarbazepine Metabolite Assay. The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK Oxcarbazepine Metabolite Assay.

Source page: https://510kreport.com/device/K153596
Methodology: https://510kreport.com/methodology