FDA.reportPublic FDA data

ARK™ Topiramate Assay

Primary DI
00858724003001
Brand
ARK™ Topiramate Assay
Company
ARK DIAGNOSTICS INC
Model
5015-0001-00
Catalog number
5015-0001-00
Device description
The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
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
K083799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083799000TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00Ark Diagnostics, Inc.2009-04-16NWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858724003001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858724003001008587240030018587240030010858724003001

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-therapy therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
00858724003018ARK™ Zonisamide 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