Cleared Traditional

K880883 - EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)

K880883 is an FDA 510(k) clearance for EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUOR..., manufactured by Immuno Concepts, Inc.. The device is a Class 1 Microbiology device with product code GNP cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K880883 · Immuno Concepts, Inc. · Microbiology device
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Aug 1988
Decision
181d
Days
Class 1
Risk

K880883 is an FDA 510(k) clearance for the EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT). Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 181 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 Immuno Concepts, Inc. devices

FDA 510(k) Submission Details - K880883

510(k) Number K880883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date August 30, 1988
Days to Decision 181 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
79d slower than avg
Panel avg: 102d · This submission: 181d
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 10
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K880883.
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 (ENZYME)
K880885 · Immuno Concepts, Inc. · Aug 1988
EBV-CHECK(TM) TEST KIT (IGG)
K871373 · Diagnostic Technology, Inc. · Jun 1987
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408 · Diagnostic Technology, Inc. · Nov 1986