Cleared Traditional

BION EBV-M (VCA) TEST SYSTEM (K893240) - FDA 510(k) Clearance

Class I Microbiology device.

K893240 · Bion Ent., Ltd. · Microbiology device
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Jul 1989
Decision
77d
Days
Class 1
Risk

K893240 is an FDA 510(k) clearance for the BION EBV-M (VCA) TEST SYSTEM. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 77 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 Bion Ent., Ltd. devices

Submission Details

510(k) Number K893240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1989
Decision Date July 14, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
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

Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K893240.
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc. · Apr 2005
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020 · Ortho Diagnostic Systems, Inc. · Jul 1993
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