Cleared Traditional

K891785 - BION EBV-G (VCA) TEST SYSTEM

K891785 is an FDA 510(k) clearance for BION EBV-G (VCA) TEST SYSTEM, manufactured by Bion Ent., Ltd.. The device is a Class 1 Microbiology device with product code JRY cleared through the Traditional 510(k) pathway after a 160-day FDA review.

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

FDA 510(k) Submission Details - K891785

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.

JRY Device Classification - Class 1, General Controls

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.