Cleared Traditional

K864604 - EBV VCA IGM ANTIBODY ASSAY KIT

K864604 is the FDA 510(k) clearance for EBV VCA IGM ANTIBODY ASSAY KIT by Granbio, Inc.. It is a Class 1 Microbiology device (product code LJN) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K864604 · Granbio, Inc. · Microbiology device
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Feb 1987
Decision
70d
Days
Class 1
Risk

K864604 is an FDA 510(k) clearance for the EBV VCA IGM ANTIBODY ASSAY KIT. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on February 2, 1987 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Granbio, Inc. devices

Submission Details

510(k) Number K864604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1986
Decision Date February 02, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 102d · This submission: 70d
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 12
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K864604.
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886 · Immuno Concepts, Inc. · Aug 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · E.I. Dupont DE Nemours & Co., Inc. · Jul 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