Cleared Traditional

K113809 - HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113809 · Hitachi Chemical Diagnostics, Inc. · Immunology device
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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

Submission Details

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.

Device Classification

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.