Cleared Traditional

K882447 - EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) A...

K882447 is an FDA 510(k) clearance for EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) A..., manufactured by Zeus Scientific, Inc.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K882447 · Zeus Scientific, Inc. · Microbiology device
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Dec 1988
Decision
184d
Days
Class 1
Risk

K882447 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES. Classified as Epstein-barr Virus, Other (product code LSE), 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

FDA 510(k) Submission Details - K882447

510(k) Number K882447 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.

LSE Device Classification - Class 1, General Controls

Product Code LSE Epstein-barr Virus, Other
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 - LSE Epstein-barr Virus, Other

All 30
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K882447.
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
K883870 · Clinical Sciences, Inc. · Jul 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
K883871 · Clinical Sciences, Inc. · Jul 1989
STAT TEST KIT FOR EB-VCA IGG ANTIBODY
K891086 · Whittaker Bioproducts, Inc. · May 1989
FIAX TEST KIT FOR EB-VCA-G ANTIBODY
K882023 · Whittaker Bioproducts, Inc. · Aug 1988
EBV-EA TEST
K872617 · Gull Laboratories, Inc. · Jan 1988