Cleared Traditional

EBNA STAT TEST KIT (K911473) - FDA 510(k) Clearance

Class I Microbiology device.

K911473 · Whittaker Bioproducts, Inc. · Microbiology device
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Sep 1991
Decision
174d
Days
Class 1
Risk

K911473 is an FDA 510(k) clearance for the EBNA STAT TEST KIT. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on September 25, 1991 after a review of 174 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 Whittaker Bioproducts, Inc. devices

Submission Details

510(k) Number K911473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date September 25, 1991
Days to Decision 174 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 102d · This submission: 174d
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.