Identifiers
- 510(k) Number
- K063662 FDA 510(k)
- FDA Product Code
- NBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1117 FDA 510(k)
- Regulation Number
- 862.1117 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ramp NT-proBNP Assay is a natriuretic peptide test classified under clinical chemistry. It is a quantitative diagnostic test used to aid in the diagnosis and assessment of heart failure severity, as well as in patient risk stratification.
This device has received FDA 510k clearance. It is designed for use as a whole blood assay to provide rapid diagnostic results.
Frequently asked questions
What is the primary clinical use of the RAMP NT-proBNP Assay?
This assay is a quantitative diagnostic test designed to assist clinicians in the diagnosis and assessment of heart failure severity. It also serves as a tool for patient risk stratification.
What type of sample is required for this test?
The RAMP NT-proBNP Assay is designed for use as a whole blood assay, allowing for rapid diagnostic results in a clinical setting.
Has this device received regulatory clearance?
Yes, the RAMP NT-proBNP Assay has received FDA 510k clearance, which indicates it has been reviewed and found to be substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Spend Management, Corporate Cards & Accounts Payable Solutions | Ramp, Ramp NT Pro BNP Test Kit | Response Biomedical, Ramp Login Page: Time is money. Save both., Point Of Care Testing & Troponin I | Response Biomedical, RAMP NT-proBNP Test - JANT PHARMACAL CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063662 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Response Biomedical Corp.
Sources (1)
- FDA 510(k) K063662 24 fields · synced Sep 26, 2026