Cleared Traditional

EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST (K882440) - FDA 510(k) Clearance

Class I Microbiology device.

K882440 · Zeus Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
184d
Days
Class 1
Risk

K882440 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 15, 1988 after a review of 184 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 Zeus Scientific, Inc. devices

Submission Details

510(k) Number K882440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1988
Decision Date December 15, 1988
Days to Decision 184 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
82d slower than avg
Panel avg: 102d · This submission: 184d
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.

Regulatory Peers - LLM Test, Antigen, Nuclear, Epstein-barr Virus

Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K882440.
ADVIA Centaur EBV-EBNA IgG
K233605 · Biokit, S.A. · Aug 2024
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K984133 · Zeus Scientific, Inc. · Jan 1999
EBNA IGG ELISA TEST SYSTEM
K932742 · Zeus Scientific, Inc. · May 1995
DU PONT EBNA-IGG ANTIBODY ELISA KIT
K875203 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1988