Cleared Traditional

K860549 - DU PONT C-REACTIVE PROTEIN (CRP) CALIBR...

K860549 is the FDA 510(k) clearance for DU PONT C-REACTIVE PROTEIN (CRP) CALIBR... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K860549 · E.I. Dupont DE Nemours & Co., Inc. · Immunology device
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Jun 1986
Decision
117d
Days
Class 2
Risk

K860549 is an FDA 510(k) clearance for the DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on June 10, 1986 after a review of 117 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K860549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1986
Decision Date June 10, 1986
Days to Decision 117 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
13d slower than avg
Panel avg: 104d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Immunology devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 81
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K860549.
C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS
K863628 · Technicon Instruments Corp. · Oct 1986
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST
K863328 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1986
ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR
K863329 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1986
DU PONT C-REACTIVE PROTEIN (CRP) ASSAY
K860550 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
TDX C-REACTIVE PROTEIN
K854542 · Abbott Laboratories · Jan 1986
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI
K831958 · Kent Laboratories, Inc. · Jul 1983