Cleared Traditional

K022690 - PAROS CRP

K022690 is the FDA 510(k) clearance for PAROS CRP by Horiba, Ltd.. It is a Class 2 Immunology device (product code DCN) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K022690 · Horiba, Ltd. · Immunology device
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Dec 2002
Decision
132d
Days
Class 2
Risk

K022690 is an FDA 510(k) clearance for the PAROS CRP. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Horiba, Ltd. (Irvine, US). The FDA issued a Cleared decision on December 23, 2002 after a review of 132 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 Horiba, Ltd. devices

Submission Details

510(k) Number K022690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2002
Decision Date December 23, 2002
Days to Decision 132 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 104d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCN System, Test, C-reactive Protein
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 - DCN System, Test, C-reactive Protein

All 36
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K022690.
DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH
K061825 · Dade Behring, Inc. · Sep 2006
TINA-QUANT CRP (LATEX)
K032336 · Roche Diagnostics Corp. · Aug 2003
C-REACTIVE PROTEIN (CRP)
K030899 · Abbott Laboratories · Jul 2003
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002
BAYER ADVIA IMS SYSTEM
K012337 · Bayer Corp. · Dec 2001
CRP HS TEST SYSTEM
K003400 · Roche Diagnostics Corp. · May 2001