Cleared Traditional

K891785 - BION EBV-G (VCA) TEST SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K891785 · Bion Ent., Ltd. · Microbiology device
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Aug 1989
Decision
160d
Days
Class 1
Risk

K891785 is an FDA 510(k) clearance for the BION EBV-G (VCA) TEST SYSTEM. Classified as Antiserum, Fluorescent, Epstein-barr Virus (product code JRY), Class I - General Controls.

Submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on August 31, 1989 after a review of 160 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 Bion Ent., Ltd. devices

Submission Details

510(k) Number K891785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date August 31, 1989
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 102d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRY Antiserum, Fluorescent, 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.