FDA.reportPublic FDA data

ARK™ Methotrexate II Control

Primary DI
00812101031209
Brand
ARK™ Methotrexate II Control
Company
ARK DIAGNOSTICS INC
Model
5071-0003-01
Catalog number
5071-0003-01
Device description
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
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
LAOEnzyme Immunoassay, Methotrexate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAOEnzyme Immunoassay, MethotrexateUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232017000ARK Methotrexate II AssayArk Diagnostics, Inc.2023-12-20LAO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812101031209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812101031209008121010312098121010312090812101031209

GMDN Terms#

Term, Definition table
TermDefinition
Methotrexate therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antineoplastic drug methotrexate 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
00812101031162ARK™ Methotrexate II AssayARK DIAGNOSTICS INCLAO2024-10-24
00812101031179ARK™ Methotrexate II AssayARK DIAGNOSTICS INCLAO2024-10-24
00812101031186ARK™ Methotrexate II CalibratorARK DIAGNOSTICS INCLAO2024-10-24
00812101031193ARK™ Methotrexate II ControlARK DIAGNOSTICS INCLAO2024-10-24
00812101031216ARK™ Methotrexate II ControlARK DIAGNOSTICS INCLAO2024-10-24
00812101031223ARK™ Methotrexate II Dilution BufferARK DIAGNOSTICS INCLAO2024-10-24
07613336224816ONLINE TDM MethotrexateRoche Diagnostics GmbHLAO2024-03-25
07613336224823ONLINE TDM Methotrexate Roche Diagnostics GmbHLAO2024-03-25
00812101030639ARK™ Methotrexate AssayARK DIAGNOSTICS INCLAO2020-08-31
00842768001383Syva® Emit® Methotrexate AssaySiemens Healthcare Diagnostics Inc.LAO2016-09-24
00858724003056ARK™ Methotrexate AssayARK DIAGNOSTICS INCLAO2016-09-24
00858724003216ARK™ Methotrexate Assay (c-pack)ARK DIAGNOSTICS INCLAO2016-09-24
00858724003254ARK™ Methotrexate AssayARK DIAGNOSTICS INCLAO2016-09-24
00380740011611ABBOTTABBOTT LABORATORIESLAO2016-09-09
00380740011628ABBOTTABBOTT LABORATORIESLAO2016-09-09
00380740011635ABBOTTABBOTT LABORATORIESLAO2016-09-09