FDA.reportPublic FDA data

ARK™ Gabapentin Assay (c-pack)

Primary DI
00858724003261
Brand
ARK™ Gabapentin Assay (c-pack)
Company
ARK DIAGNOSTICS INC
Model
5025-0001-01
Catalog number
5025-0001-01
Device description
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.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTFGabapentin Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTFGabapentin AssayClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101574000ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0Ark Diagnostics, Inc.2010-11-23OTF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858724003261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003261008587240032618587240032610858724003261

GMDN Terms#

Term, Definition table
TermDefinition
Neurontin (gabapentin) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of neurontin (gabapentin) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5102706270customersupport@ark-tdm.com

Regulatory Flags#

DUNS number
164880598
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858724003414ARK™ Fentanyl Calibrator5031-0002-005031-0002-002017-04-30
00812101031599ARK™ Ketamine II Assay5083-0001-005083-0001-002025-12-27
00812101031605ARK™ Ketamine II Assay5083-0001-015083-0001-002025-12-27
00812101031612ARK™ Ketamine II Assay5083-0001-025083-0001-022025-12-27
00812101031629ARK™ Ketamine II Calibrator5083-0002-005083-0002-002025-12-27
00812101031636ARK™ Ketamine II Calibrator (Negative)5083-0002-015083-0002-012025-12-27
00812101031643ARK™ Ketamine II Calibrator (50 ng/mL Cutoff)5083-0002-025083-0002-022025-12-27
00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)5083-0002-035083-0002-032025-12-27
00812101031667ARK™ Ketamine II Control (25/75)5083-0003-005083-0003-002025-12-27
00812101031674ARK™ Ketamine II Control (75/125)5083-0003-015083-0003-012025-12-27
00812101031995ARK™ Ketamine II Assay5083-0001-035083-0001-032025-12-27
00812101031001DRI Tramadol Assay - 500 mLB40000350B400003502024-11-14
00812101031018DRI Tramadol Assay - 115mLB40000351B400003512024-11-14
00812101031025DRI Tramadol Negative Calibrator KitB40000353B400003532024-11-14
00812101031032DRI Tramadol Cutoff Calibrator KitB40000352B400003522024-11-14
00812101031049DRI Tramadol Calibrator KitB40000366B400003662024-11-14
00812101031056DRI Tramadol Control KitB40000354B400003542024-11-14
00812101031469ARK Levetiracetam II Assay 5070-0001-015070-0001-012024-10-25
00812101030646ARK™ Levetiracetam II Assay 5070-0001-005070-0001-002024-10-24
00812101030653ARK™ Levetiracetam II Calibrator5070-0002-005070-0002-002024-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858724003049ARK™ Gabapentin AssayARK DIAGNOSTICS INCOTF2016-09-24