Cleared Traditional

K935730 - EBNA IGG ELISA TEST

K935730 is the FDA 510(k) clearance for EBNA IGG ELISA TEST by Gull Laboratories, Inc.. It is a Class 1 Microbiology device (product code LLM) cleared through the Traditional 510(k) pathway after a 657-day FDA review.

K935730 · Gull Laboratories, Inc. · Microbiology device
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Sep 1995
Decision
657d
Days
Class 1
Risk

K935730 is an FDA 510(k) clearance for the EBNA IGG ELISA TEST. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 1995 after a review of 657 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Gull Laboratories, Inc. devices

Submission Details

510(k) Number K935730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1993
Decision Date September 19, 1995
Days to Decision 657 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
555d slower than avg
Panel avg: 102d · This submission: 657d
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.

Regulatory Peers - LLM Test, Antigen, Nuclear, Epstein-barr Virus

All 12
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