Cleared Traditional

EBV(EPSTEIN-BARR VIRUS) TEST KIT (K854207) - FDA 510(k) Clearance

Class I Microbiology device.

K854207 · Immuno-Diagnostic Products, Inc. · Microbiology device
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Apr 1986
Decision
190d
Days
Class 1
Risk

K854207 is an FDA 510(k) clearance for the EBV(EPSTEIN-BARR VIRUS) TEST KIT. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Immuno-Diagnostic Products, Inc. (North Salt Lake, US). The FDA issued a Cleared decision on April 24, 1986 after a review of 190 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 Immuno-Diagnostic Products, Inc. devices

Submission Details

510(k) Number K854207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1985
Decision Date April 24, 1986
Days to Decision 190 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 102d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNP Antiserum, Cf, 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.