RAMP® Cardiac Controls - Level 2

Basic Information

• Brand Name: RAMP® Cardiac Controls - Level 2
• Primary DI: 10627966005305
• Version / Model: C5003-2
• Catalog Number: C5003-2
• Company Name: Response Biomedical Corp
• Labeler DUNS: 248609018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-20
• Public Version: 2
• Public Version Date: 2025-11-13
• Public Version Status: Update
• Public Device Record Key: fff3e5ac-b935-400b-8fa4-ceeca846d001

Device Description

The RAMP® Cardiac Controls are prepared from human plasma, human serum and human proteins. Preservatives and stabilizers have been added to maintain product integrity. The RAMP® Cardiac Controls are ready-to-use liquid control requiring no reconstitution or frozen storage.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47016	Multiple cardiac marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include 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 and/or troponin T.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10627966005305	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080973	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 kit with 6 X 3 mL vials

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: RAMP® Cardiac Controls are stable until the expiration date on the vial when stored unopened at 2-8°C. Once opened, RAMP® Cardiac Controls are stable for 30 days when stored tightly capped at 2-8°C