Cleared Traditional

K872539 - EUROGENETICS CRP ELISA

K872539 is an FDA 510(k) clearance for EUROGENETICS CRP ELISA, manufactured by Eurogenetics. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K872539 · Eurogenetics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
113d
Days
Class 2
Risk

K872539 is an FDA 510(k) clearance for the EUROGENETICS CRP ELISA. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Eurogenetics (North Caldwell, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 113 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 Eurogenetics devices

FDA 510(k) Submission Details - K872539

510(k) Number K872539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1987
Decision Date October 20, 1987
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 105d · This submission: 113d
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 51
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K872539.
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
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
K860679 · Orion Corp. · Aug 1986
CPR SLIDE EIKEN
K854819 · Syn-Kit, Inc. · Feb 1986
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS)
K855057 · Behring Diagnostics, Inc. · Feb 1986