Cleared Traditional

K083412 - PATHFAST HSCRP

K083412 is an FDA 510(k) clearance for PATHFAST HSCRP, manufactured by Mitsubishi Kagaku Iatron. The device is a Class 2 Chemistry device with product code DCN cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K083412 · Mitsubishi Kagaku Iatron · Chemistry device
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Mar 2009
Decision
111d
Days
Class 2
Risk

K083412 is an FDA 510(k) clearance for the PATHFAST HSCRP. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Mitsubishi Kagaku Iatron (Seattle, US). The FDA issued a Cleared decision on March 9, 2009 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - 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 - K083412

510(k) Number K083412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2008
Decision Date March 09, 2009
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCN System, Test, C-reactive Protein

All 51
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K083412.
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
K113809 · Hitachi Chemical Diagnostics, Inc. · Aug 2012
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
K091052 · Abaxis, Inc. · Jan 2010
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp. · Mar 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · Alfa Wassermann Diagnostic Technologies, Inc. · Jan 2009
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS
K072658 · Siemens Medical Solutions Diagnostics · Apr 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · Roche Diagnostics Corp. · Mar 2008