510(k) K101574
K101574 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0". The FDA issued a decision of Substantially Equivalent on November 23, 2010. The device falls under product code OTF (Gabapentin Assay), a Class II device regulated under 21 CFR 862.3350. Ark Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2010
- Date Received
- June 7, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gabapentin Assay
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type
Test for the quantitative determination of gabapentin in human serum or plasma. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.