Cleared Traditional

K884829 - EBV EARLY ANTIGEN (R+D) (FDA 510(k) Clearance)

Class I Microbiology device.

K884829 · Hillcrest Biologicals · Microbiology device
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Apr 1989
Decision
145d
Days
Class 1
Risk

K884829 is an FDA 510(k) clearance for the EBV EARLY ANTIGEN (R+D). Classified as Antiserum, Fluorescent, Epstein-barr Virus (product code JRY), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on April 12, 1989 after a review of 145 days - within the typical 510(k) review window.

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 Hillcrest Biologicals devices

Submission Details

510(k) Number K884829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date April 12, 1989
Days to Decision 145 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 102d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JRY Antiserum, Fluorescent, 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.