Cleared Traditional

K840417 - EBNA ACIF KIT

K840417 is an FDA 510(k) clearance for EBNA ACIF KIT, manufactured by Litton Bionetics. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K840417 · Litton Bionetics · Microbiology device
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Dec 1984
Decision
331d
Days
Class 1
Risk

K840417 is an FDA 510(k) clearance for the EBNA ACIF KIT. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Litton Bionetics (Charleston, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 331 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Litton Bionetics devices

FDA 510(k) Submission Details - K840417

510(k) Number K840417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1984
Decision Date December 27, 1984
Days to Decision 331 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 102d · This submission: 331d
Pathway characteristics
Predicate-based equivalence.

LLM Device Classification - Class 1, General Controls

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.