Cleared Traditional

K113809 - HITACHI CLINICAL ANALYZER S TEST REGENT...

K113809 is an FDA 510(k) clearance for HITACHI CLINICAL ANALYZER S TEST REGENT..., manufactured by Hitachi Chemical Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K113809 · Hitachi Chemical Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
238d
Days
Class 2
Risk

K113809 is an FDA 510(k) clearance for the HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP). Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 17, 2012 after a review of 238 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hitachi Chemical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K113809

510(k) Number K113809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2011
Decision Date August 17, 2012
Days to Decision 238 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 104d · This submission: 238d
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 Immunology devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 41
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K113809.
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · The Binding Site Group , Ltd. · Oct 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · The Binding Site Group , Ltd. · Feb 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp. · Mar 2009
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · Roche Diagnostics Corp. · Mar 2008
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825 · Dade Behring, Inc. · Sep 2006