Cleared Traditional

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

K080269 is the FDA 510(k) clearance for TRIAGE CARDIOPROFILER AND PROFILER S.O.... by Biosite Incorporated. It is a Class 2 Chemistry device (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

Submission Details

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.

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 39
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