Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test

Basic Information

• Brand Name: Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test
• Primary DI: B103A25CS30021
• Version / Model: CS3002
• Catalog Number: CS3002
• Company Name: International Point of Care Incorporated
• Labeler DUNS: 243942278
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: f67d07bc-dfd4-46cf-8165-19509b9e8123

Device Description

Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DEA	Myoglobin, Fitc, Antigen, Antiserum, Control	Immunology	866.5680	2
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	862.1215	2
JHT	Chromatographic Separation, Cpk Isoenzymes	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61295	Multiple cardiac marker IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple combinations of cardiac markers [e.g., B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I, troponin T] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B103A25CS30021	HIBCC
Unit of Use	B103CS30020	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K020950	000
K022409	000