510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101574Substantially Equivalent

Ark Gabapentin Assay, Ark Gabepentin Califrator, and Ark Gabapentin Control Model5025-0001-00, 5025-0002-00, 5025-0003-0

Ark Diagnostics Inc, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101574 is the FDA 510(k) clearance record for ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0, a class II device, cleared for Ark Diagnostics, Inc. on under FDA product code OTF (Gabapentin Assay). FDA's definition for product code OTF reads: "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". FDA records list 17 510(k) clearances for Ark Diagnostics, Inc., from to . As of , FDA records show no recalls naming K101574.

Clearance record

Decision date
Received
(169 days to decision)
Product code
OTF Gabapentin Assay
Regulation
21 CFR 862.3350
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Ark Diagnostics, Inc. 1190 Bordeaux Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTF

Trailing 12 months

FDA records hold no clearances under product code OTF in the trailing twelve months.

FDA records show no clearances under product code OTF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OTF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260