Cleared Traditional

K013787 - NYCOCARD CRP

K013787 is the FDA 510(k) clearance for NYCOCARD CRP by Primus Corp.. It is a Class 2 Chemistry device (product code DCK) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K013787 · Primus Corp. · Chemistry device
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May 2002
Decision
181d
Days
Class 2
Risk

K013787 is an FDA 510(k) clearance for the NYCOCARD CRP. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Primus Corp. (Kansas City, US). The FDA issued a Cleared decision on May 14, 2002 after a review of 181 days - an extended review cycle.

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 Primus Corp. devices

Submission Details

510(k) Number K013787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2001
Decision Date May 14, 2002
Days to Decision 181 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
93d slower than avg
Panel avg: 88d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 82
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K013787.
HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS
K023269 · Instrumentation Laboratory CO · Dec 2002
K-ASSAY HS-CRP CONTROLS
K022486 · Kamiya Biomedical Co. · Aug 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · Hemagen Diagnostics, Inc. · Jul 2002
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597 · Beckman Coulter, Inc. · May 2001
K-ASSAY HS-CRP CONTROLS
K011079 · Kamiya Biomedical Co. · May 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
K010236 · Beckman Coulter, Inc. · Apr 2001