Cleared Traditional

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL (K031607) - FDA 510(k) Clearance

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

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

Submission Details

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
37d slower than avg
Panel avg: 104d · This submission: 141d
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 Immunology devices follow this clearance model.

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

All 125
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