Cleared Traditional

K875204 - DU PONT VCA-IGM ANTIBODY ELISA KIT

K875204 is the FDA 510(k) clearance for DU PONT VCA-IGM ANTIBODY ELISA KIT by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 1 Microbiology device (product code LJN) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K875204 · E.I. Dupont DE Nemours & Co., Inc. · Microbiology device
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Jul 1988
Decision
203d
Days
Class 1
Risk

K875204 is an FDA 510(k) clearance for the DU PONT VCA-IGM ANTIBODY ELISA KIT. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 203 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - the FDA microbiology 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 Microbiology 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 K875204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1987
Decision Date July 08, 1988
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 102d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJN Antibody Igm, If, Epstein-barr Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LJN Antibody Igm, If, Epstein-barr Virus

All 10
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K875204.
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884 · Immuno Concepts, Inc. · Aug 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886 · Immuno Concepts, Inc. · Aug 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541 · Ortho Diagnostic Systems, Inc. · May 1988
EBV-VCA-IGM IFA TEST SYSTEM
K833014 · Zeus Scientific, Inc. · Dec 1983