Not Cleared Post-NSE

DEN000010 - TRIAGE B-TYPE NATRIURETIC PEPTIDE (BN...

DEN000010 is the FDA 510(k) submission for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BN... by Biosite Incorporated. It is a Class 2 Chemistry device (product code NBC) cleared through the Post-NSE 510(k) pathway after a 5-day FDA review.

DEN000010 · Biosite Incorporated · Chemistry device
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Nov 2000
Decision
5d
Days
Class 2
Risk

DEN000010 is an FDA 510(k) submission (not cleared) for the TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Not Cleared (DENG) decision on November 20, 2000 after a review of 5 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

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Submission Details

510(k) Number DEN000010 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 15, 2000
Decision Date November 20, 2000
Days to Decision 5 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 88d · This submission: 5d
Pathway characteristics

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.