Cleared Traditional

K945280 - DUPONT DIMENSION C-REACTIVE PROTEIN METHOD

K945280 is an FDA 510(k) clearance for DUPONT DIMENSION C-REACTIVE PROTEIN METHOD, manufactured by Dupont Medical Products. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K945280 · Dupont Medical Products · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
132d
Days
Class 2
Risk

K945280 is an FDA 510(k) clearance for the DUPONT DIMENSION C-REACTIVE PROTEIN METHOD. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on March 9, 1995 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K945280

510(k) Number K945280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date March 09, 1995
Days to Decision 132 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 88
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K945280.
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K953197 · Johnson & Johnson Clinical Diagnostics, Inc. · Jul 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212 · Randox Laboratories, Ltd. · Jul 1995
MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
K951057 · Medical Analysis Systems, Inc. · Apr 1995
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
K944288 · Hemagen Diagnostics, Inc. · Oct 1994
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · Behring Diagnostics, Inc. · Oct 1994
TINA-QUANT CRP
K930621 · Boehringer Mannheim Corp. · Mar 1993