Cleared Traditional

K884591 - EBV-VCA ANTIBODY (IGG)

K884591 is an FDA 510(k) clearance for EBV-VCA ANTIBODY (IGG), manufactured by Hillcrest Biologicals. The device is a Class 1 Microbiology device with product code GNP cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K884591 · Hillcrest Biologicals · Microbiology device
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Jan 1989
Decision
82d
Days
Class 1
Risk

K884591 is an FDA 510(k) clearance for the EBV-VCA ANTIBODY (IGG). Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K884591

510(k) Number K884591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1988
Decision Date January 24, 1989
Days to Decision 82 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
20d faster than avg
Panel avg: 102d · This submission: 82d
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 19
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K884591.
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · Diamedix Corp. · Feb 1999
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
K901156 · Granbio, Inc. · Sep 1990
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
K883670 · Electro-Nucleonics, Inc. · Apr 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
K884591 · EBV-VCA ANTIBODY (IGG)
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