Cleared Special

K042442 - QUICKREAD SYSTEM: QUICKREAD CRP KIT

Also marketed or referenced as:
QUICKREAD 101 INSTRUMENT, MODEL 06088 QUICKREAD CRP CONTROL SET, MODE

K042442 is an FDA 510(k) clearance for QUICKREAD SYSTEM: QUICKREAD CRP KIT, manufactured by Orion Diagnostica, OY. The device is a Class 2 Chemistry device with product code DCK cleared through the Special 510(k) pathway after a 15-day FDA review.

K042442 · Orion Diagnostica, OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K042442

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.

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 95
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K042442.
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139 · Diagnostic Chemicals , Ltd. · Apr 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · Clinical Data, Inc. · Feb 2006
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · Stanbio Laboratory · Oct 2004
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