Cleared Traditional

K883670 - SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI

K883670 is an FDA 510(k) clearance for SEROLOGICAL TEST KIT FOR IGG ANTI. EPST..., manufactured by Electro-Nucleonics, Inc.. The device is a Class 1 Microbiology device with product code GNP cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K883670 · Electro-Nucleonics, Inc. · Microbiology device
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Apr 1989
Decision
253d
Days
Class 1
Risk

K883670 is an FDA 510(k) clearance for the SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on April 28, 1989 after a review of 253 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 Electro-Nucleonics, Inc. devices

FDA 510(k) Submission Details - K883670

510(k) Number K883670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1988
Decision Date April 28, 1989
Days to Decision 253 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 102d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

GNP Device Classification - Class 1, General Controls

Product Code GNP Antiserum, Cf, 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 - GNP Antiserum, Cf, Epstein-barr Virus

All 11
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K883670.
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829 · Diamedix Corp. · Feb 1999
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · Diamedix Corp. · Feb 1999
EBV-VCA ANTIBODY (IGG)
K884591 · Hillcrest Biologicals · Jan 1989
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)
K880883 · Immuno Concepts, Inc. · Aug 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)
K880885 · Immuno Concepts, Inc. · Aug 1988
EBV-CHECK(TM) TEST KIT (IGG)
K871373 · Diagnostic Technology, Inc. · Jun 1987