Cleared Special

K030286 - TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

K030286 is an FDA 510(k) clearance for TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL, manufactured by Biosite Incorporated. The device is a Class 2 Chemistry device with product code NBC cleared through the Special 510(k) pathway after a 24-day FDA review.

K030286 · Biosite Incorporated · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
24d
Days
Class 2
Risk

K030286 is an FDA 510(k) clearance for the TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1117 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030286

510(k) Number K030286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2003
Decision Date February 21, 2003
Days to Decision 24 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 89d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - NBC Test, Natriuretic Peptide

All 46
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K030286.
ELECSYS PROBNP IMMUNOASSAY
K032646 · Roche Diagnostics Corp. · Nov 2003
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K032525 · Bayer Healthcare, LLC · Sep 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K031038 · Bayer Healthcare, LLC · Jun 2003
ELECSYS PROBNP IMMUNOASSAY
K022516 · Roche Diagnostics Corp. · Nov 2002
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K021317 · Biosite Incorporated · Jul 2002
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
K010266 · Biosite Incorporated · Mar 2001
K030286 · TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
Download PDF FDA Summary Biosite Incorporated