FDA.reportPublic FDA data

ARK™ Levetiracetam II Assay

Primary DI
00812101030646
Brand
ARK™ Levetiracetam II Assay
Company
ARK DIAGNOSTICS INC
Model
5070-0001-00
Catalog number
5070-0001-00
Device description
The ARK Levetiracetam II Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers.
Published
2024-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORILevetiracetam Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORILevetiracetam AssayClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232522000ARK Levetiracetam II AssayArk Diagnostics, Inc.2024-02-27ORI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812101030646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812101030646008121010306468121010306460812101030646

GMDN Terms#

Term, Definition table
TermDefinition
Levetiracetam 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 the central nervous system drug levetiracetam (e.g., Keppra) 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
00812101030653ARK™ Levetiracetam II Calibrator5070-0002-005070-0002-002024-10-24
00812101030660ARK™ Levetiracetam II Control5070-0003-005070-0003-002024-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812101031469ARK Levetiracetam II Assay ARK DIAGNOSTICS INCORI2024-10-25
00812101030653ARK™ Levetiracetam II CalibratorARK DIAGNOSTICS INCORI2024-10-24
00812101030660ARK™ Levetiracetam II ControlARK DIAGNOSTICS INCORI2024-10-24
00858724003032 ARK™ Levetiracetam AssayARK DIAGNOSTICS INCORI2016-09-24