# K101574: Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control MODEL5025-0001-00, 5025-0002-00, 5025-0003-0

- Pathway: 510(k) (Traditional)
- Applicant: Ark Diagnostics, Inc.
- Decided: Nov 23, 2010 after 169 days
- Product code: OTF (Gabapentin Assay)
- Device class: 2
- Regulation: 21 CFR 862.3350
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 1.

## Indications for use
The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin. The ARK™ Gabapentin Calibrator is intended for use in calibration of the ARK Gabapentin Assay. The ARK™ Gabapentin Control is intended for use in quality control of the ARK Gabapentin Assay.

Source page: https://510kreport.com/device/K101574
Methodology: https://510kreport.com/methodology