Cleared Traditional

K013787 - NYCOCARD CRP

K013787 is an FDA 510(k) clearance for NYCOCARD CRP, manufactured by Primus Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K013787

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.

DCK Device Classification - Class 2, Special Controls

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 106
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K013787.
K-ASSAY HS-CRP CONTROLS
K022486 · Kamiya Biomedical Co. · Aug 2002
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
K021194 · Hemagen Diagnostics, Inc. · Jul 2002
RDI HS CRP KIT
K021609 · Reference Diagnostics, Inc. · Jun 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