Cleared Traditional

K080269 - TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS

K080269 is an FDA 510(k) clearance for TRIAGE CARDIOPROFILER AND PROFILER S.O...., manufactured by Biosite Incorporated. The device is a Class 2 Chemistry device with product code NBC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K080269 · Biosite Incorporated · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
126d
Days
Class 2
Risk

K080269 is an FDA 510(k) clearance for the TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS. 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 June 6, 2008 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosite Incorporated devices

FDA 510(k) Submission Details - K080269

510(k) Number K080269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2008
Decision Date June 06, 2008
Days to Decision 126 days
Submission Type Traditional
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
38d slower than avg
Panel avg: 88d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 41
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K080269.
ST AIA-PACK BNP
K192380 · Fujirebio Diagnostics,Inc. · Aug 2020
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
K092649 · Roche Diagnostics Corp. · Feb 2010
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRIDGE, MODEL RF623
K082645 · Siemens Healthcare Diagnostics · Sep 2008
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA
K080578 · Siemens Healthcare Diagnostics, Inc. · May 2008
VIDAS NT-PROBNP ASSAY, MODEL: 30 449
K073091 · bioMerieux, Inc. · Feb 2008
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437 · Roche Diagnostics · Feb 2008