Cleared Traditional

RAMP NT-PROBNP ASSAY (K063662) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063662 · Response Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
591d
Days
Class 2
Risk

K063662 is an FDA 510(k) clearance for the RAMP NT-PROBNP ASSAY. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Response Biomedical Corp. (Burnaby, British Columbia, CA). The FDA issued a Cleared decision on July 21, 2008 after a review of 591 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1117 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Response Biomedical Corp. devices

Submission Details

510(k) Number K063662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2006
Decision Date July 21, 2008
Days to Decision 591 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
503d slower than avg
Panel avg: 88d · This submission: 591d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBC Test, Natriuretic Peptide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1117
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBC Test, Natriuretic Peptide

All 44
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