Cleared Traditional

EBV-EA TEST (K872617) - FDA 510(k) Clearance

Class I Microbiology device.

K872617 · Gull Laboratories, Inc. · Microbiology device
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Jan 1988
Decision
183d
Days
Class 1
Risk

K872617 is an FDA 510(k) clearance for the EBV-EA TEST. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 183 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 Gull Laboratories, Inc. devices

Submission Details

510(k) Number K872617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date January 05, 1988
Days to Decision 183 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 102d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSE Epstein-barr Virus, Other
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.