Cleared Traditional

K142993 - QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

K142993 is an FDA 510(k) clearance for QuikRead go CRP, manufactured by Orion Diagnostica, OY. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 511-day FDA review.

K142993 · Orion Diagnostica, OY · Immunology device
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Mar 2016
Decision
511d
Days
Class 2
Risk

K142993 is an FDA 510(k) clearance for the QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Se.... Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Orion Diagnostica, OY (Oulu, FI). The FDA issued a Cleared decision on March 10, 2016 after a review of 511 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

FDA 510(k) Submission Details - K142993

510(k) Number K142993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2014
Decision Date March 10, 2016
Days to Decision 511 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
406d slower than avg
Panel avg: 105d · This submission: 511d
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 115
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DIAZYME HSCRP POC TEST KIT
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K142993 · QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
Download PDF Orion Diagnostica, OY