Cleared Traditional

K860679 - IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN

K860679 is an FDA 510(k) clearance for IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN, manufactured by Orion Corp.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K860679 · Orion Corp. · Immunology device
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Aug 1986
Decision
160d
Days
Class 2
Risk

K860679 is an FDA 510(k) clearance for the IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on August 4, 1986 after a review of 160 days - an extended review cycle.

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 Corp. devices

FDA 510(k) Submission Details - K860679

510(k) Number K860679 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 25, 1986
Decision Date August 04, 1986
Days to Decision 160 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 105d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K860679.
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD
K883515 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1988
WAKO(TM) CRP
K882374 · Wako Chemicals USA, Inc. · Jul 1988
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
K880728 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
CPR SLIDE EIKEN
K854819 · Syn-Kit, Inc. · Feb 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · Behring Diagnostics, Inc. · Feb 1986
CRP SLIDE TEST KIT
K840699 · Difco Laboratories, Inc. · Mar 1984