Cleared Traditional

K072189 - PATHFAST NTPROBNP AND D-DIMER TESTS

K072189 is the FDA 510(k) clearance for PATHFAST NTPROBNP AND D-DIMER TESTS by Mitsubishi Kagaku Iatron. It is a Class 2 Chemistry device (product code NBC) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K072189 · Mitsubishi Kagaku Iatron · Chemistry device
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Feb 2008
Decision
183d
Days
Class 2
Risk

K072189 is an FDA 510(k) clearance for the PATHFAST NTPROBNP AND D-DIMER TESTS. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on February 5, 2008 after a review of 183 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 Mitsubishi Kagaku Iatron devices

Submission Details

510(k) Number K072189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date February 05, 2008
Days to Decision 183 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 88d · This submission: 183d
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 40
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K072189.
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
ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
K072437 · Roche Diagnostics · 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