Cleared Traditional

K072189 - PATHFAST NTPROBNP AND D-DIMER TESTS

K072189 is an FDA 510(k) clearance for PATHFAST NTPROBNP AND D-DIMER TESTS, manufactured by Mitsubishi Kagaku Iatron. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K072189

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
Combination Product No
PCCP Authorized No
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.

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 44
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