FDA.reportPublic FDA data

Cardiac STATus® TnI

Primary DI
B103A20CS10021
Brand
Cardiac STATus® TnI
Company
International Point of Care Incorporated
Model
CS1002
Catalog number
CS1002
Device description
Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMIImmunoassay Method, Troponin Subunit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMIImmunoassay Method, Troponin SubunitClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014105000SPECTRAL'S TROPONIN ISpectral Diagnostics, Inc.2002-02-01MMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B103A20CS10021PrimaryHIBCC0
B103CS10020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Troponin I IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
416-847-2777customerservice@ipocdx.com

Regulatory Flags#

DUNS number
243942278
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B103CSC30231Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I)CSC3023CSC30232022-12-07
B103A10CS10021Cardiac STATus® TnICS1002CS10022016-09-15
B103A10CS30021Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test CS3002CS30022016-09-15
B103A20CS30021Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test CS3002CS30022016-09-15
B103A25CS10021Cardiac STATus® TnICS1002CS10022016-09-15
B103A25CS30021Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test CS3002CS30022016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750033522VITROSORTHO CLINICAL DIAGNOSTICSMMI2025-12-30
10054749003058i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
00054749003051i-STAT hs-TnI cartridgeAbbott Point of Care Inc.MMI2025-04-29
04987595301803PATHFAST hs-cTnI-IIPHC CORPORATIONMMI2024-05-01
00380740194062AlinityABBOTT IRELANDMMI2022-07-08
00380740194079AlinityABBOTT IRELANDMMI2022-07-08
07613336158951Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2022-03-01
07613336158982Elecsys Troponin T Gen 5Roche Diagnostics GmbHMMI2021-09-23
00894175000466RapiCard™ InstaTestDiagnostic Automation, Inc.MMI2021-08-27
00083059070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KITBIOMERICA, INC.MMI2020-07-01
00630414293783Atellica IM TNIHSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00630414293790Atellica IM TnI-UltraSiemens Healthcare Diagnostics Inc.MMI2020-05-31
00380740175498ARCHITECTABBOTT IRELANDMMI2019-12-03
00380740175504ARCHITECTABBOTT IRELANDMMI2019-12-03
00842768037726Dimension EXL LOCI Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-10-16
00842768037719Dimension Vista Troponin I High SensitiveSiemens Healthcare Diagnostics Inc.MMI2019-08-05
00895160002496Fluoro-CheckTM AMI 3 in 1NANO-DITECH CORPORATIONMMI2019-05-24
00816870020679cTnI AccuBind ELISA Test System - 96 WellsMONOBIND, INC.MMI2019-02-11
00816870020686cTnI AccuBind ELISA Test System - 192 WellsMONOBIND, INC.MMI2019-02-11
00816870022352cTnI AccuLite CLIA Test System - 96 WellsMONOBIND, INC.MMI2019-02-11
00816870022369cTnI AccuLite CLIA Test System - 192 WellsMONOBIND, INC.MMI2019-02-11
30014613337157TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337164TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337911TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337928TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337935TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337942TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01
30014613337973TriageQUIDEL CARDIOVASCULAR INC.MMI2018-11-01