Not Cleared Post-NSE

DEN000010 - TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

DEN000010 is an FDA 510(k) submission for TRIAGE B-TYPE NATRIURETIC PEPTIDE (BN..., manufactured by Biosite Incorporated. The device is a Class 2 Chemistry device with 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.

FDA 510(k) Submission Details - DEN000010

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
84d faster than avg
Panel avg: 89d · This submission: 5d
Pathway characteristics

NBC Device Classification - Class 2, Special Controls

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.

DEN000010 · TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
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