Cleared Traditional

K072437 - ELECSYS PROBNP II

K072437 is the FDA 510(k) clearance for ELECSYS PROBNP II by Roche Diagnostics. It is a Class 2 Chemistry device (product code NBC) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K072437 · Roche Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
166d
Days
Class 2
Risk

K072437 is an FDA 510(k) clearance for the ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 5, 2008 after a review of 166 days - an extended review cycle.

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 Roche Diagnostics devices

Submission Details

510(k) Number K072437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2007
Decision Date February 05, 2008
Days to Decision 166 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
78d slower than avg
Panel avg: 88d · This submission: 166d
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 K072437.
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269 · Biosite Incorporated · Jun 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
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
K071834 · Dade Behring, Inc. · Aug 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
K071767 · Dade Behring, Inc. · Aug 2007
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · Dade Behring, Inc. · Sep 2006