Cleared Traditional

K031607 - ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

K031607 is an FDA 510(k) clearance for ORION DIAGNOSTICA QUIKREAD CRP KIT AND ..., manufactured by Orion Diagnostica, Div. Orion Corp.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K031607 · Orion Diagnostica, Div. Orion Corp. · Immunology device
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Oct 2003
Decision
141d
Days
Class 2
Risk

K031607 is an FDA 510(k) clearance for the ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Orion Diagnostica, Div. Orion Corp. (Espoo, FI). The FDA issued a Cleared decision on October 10, 2003 after a review of 141 days - within the typical 510(k) review window.

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 Orion Diagnostica, Div. Orion Corp. devices

FDA 510(k) Submission Details - K031607

510(k) Number K031607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2003
Decision Date October 10, 2003
Days to Decision 141 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 105d · This submission: 141d
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 Immunology devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 101
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K031607.
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
K040241 · Genzyme Corp. · Jun 2004
CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)
K040579 · Cholestech Corp. · Jun 2004
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 2003
EXTENDED RANGE HS CRP KIT, CAT NO:9200
K030044 · Reference Diagnostics, Inc. · Sep 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · Wako Chemicals USA, Inc. · Jun 2003
VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
K030626 · Ortho-Clinical Diagnostics, Inc. · Mar 2003