Cleared Traditional

EBNA ENZYME IMMUNOASSAY KIT (K951822) - FDA 510(k) Clearance

Class I Microbiology device.

K951822 · Granbio, Inc. · Microbiology device
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Feb 1996
Decision
301d
Days
Class 1
Risk

K951822 is an FDA 510(k) clearance for the EBNA ENZYME IMMUNOASSAY KIT. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on February 15, 1996 after a review of 301 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 Granbio, Inc. devices

Submission Details

510(k) Number K951822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date February 15, 1996
Days to Decision 301 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 102d · This submission: 301d
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.