Cleared Traditional

K894626 - EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN (FDA 510(k) Clearance)

Class I Microbiology device.

K894626 · Bion Ent., Ltd. · Microbiology device
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Oct 1989
Decision
88d
Days
Class 1
Risk

K894626 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 88 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 K894626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date October 16, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLM Test, Antigen, Nuclear, 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.