Cleared Traditional

K884829 - EBV EARLY ANTIGEN (R+D)

K884829 is an FDA 510(k) clearance for EBV EARLY ANTIGEN (R+D), manufactured by Hillcrest Biologicals. The device is a Class 1 Microbiology device with product code JRY cleared through the Traditional 510(k) pathway after a 145-day FDA review.

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

FDA 510(k) Submission Details - K884829

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 102d · This submission: 145d
Pathway characteristics
Predicate-based equivalence.

JRY Device Classification - Class 1, General Controls

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.