Cleared Special

K042442 - QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085 (FDA 510(k) Clearance)

Also includes:
QUICKREAD 101 INSTRUMENT, MODEL 06088 QUICKREAD CRP CONTROL SET, MODE

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042442 · Orion Diagnostica, OY · Chemistry device
Download Printable Device Report (PDF)
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Sep 2004
Decision
15d
Days
Class 2
Risk

K042442 is an FDA 510(k) clearance for the QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Orion Diagnostica, OY (Espoo, FI). The FDA issued a Cleared decision on September 24, 2004 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orion Diagnostica, OY devices

Submission Details

510(k) Number K042442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2004
Decision Date September 24, 2004
Days to Decision 15 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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

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