FDA.reportPublic FDA data

ARK™ Zonisamide Assay

Primary DI
00858724003018
Brand
ARK™ Zonisamide Assay
Company
ARK DIAGNOSTICS INC
Model
5022-0001-00
Catalog number
5022-0001-00
Device description
The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The ARK™ Zonisamide Assay consists of reagents RI anti-zonisamide polyclonal antibody with substrate and R2 zonisamide epitope labeled with bacterial G6PDH enzyme.
Published
2016-09-24
Public version status
Update
Distribution status
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
NWMImmunoassay, Anti-Seizure Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWMImmunoassay, Anti-Seizure DrugClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091884000ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003Ark Diagnostics, Inc.2009-12-09NWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858724003018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003018008587240030188587240030180858724003018

GMDN Terms#

Term, Definition table
TermDefinition
Zonisamide therapeutic drug monitoring 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 quantitative measurement and therapeutic monitoring of the central nervous system drug zonisamide 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
00812101031261ARK™ Pregabalin II Assay ARK DIAGNOSTICS INCNWM2023-12-22
00812101030448ARK™ Pregabalin II AssayARK DIAGNOSTICS INCNWM2019-07-03
00884883011250QMS Topiramate Immunoassay Control setMicrogenics CorporationNWM2016-10-04
00858724003001ARK™ Topiramate AssayARK DIAGNOSTICS INCNWM2016-09-24
00858724003278ARK™ Pregabalin Urine AssayARK DIAGNOSTICS INCNWM2016-09-24
00884883011175QMS Topiramate ImmunoassayMicrogenics CorporationNWM2016-09-24
00884883011199QMS Zonisamide ImmunoassayMicrogenics CorporationNWM2016-09-24
00884883011298QMS Topiramate Immunoassay Microgenics CorporationNWM2016-09-24
00884883012707QMS Topiramate AssayMicrogenics CorporationNWM2016-09-12
00884883012714QMS Zonisamide AssayMicrogenics CorporationNWM2016-09-12