Cleared Traditional

K864347 - INDIRECT IMMUNOFLUORESCENT ANTIBODY ASS...

K864347 is the FDA 510(k) clearance for INDIRECT IMMUNOFLUORESCENT ANTIBODY ASS... by Granbio, Inc.. It is a Class 1 Microbiology device (product code GNP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K864347 · Granbio, Inc. · Microbiology device
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Feb 1987
Decision
90d
Days
Class 1
Risk

K864347 is an FDA 510(k) clearance for the INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on February 2, 1987 after a review of 90 days - within the typical 510(k) review window.

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 Granbio, Inc. devices

Submission Details

510(k) Number K864347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date February 02, 1987
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K864347.
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
ENI ANTIBODY TO EPSTEIN-BARR VIRUS
K810860 · Electro-Nucleonics Laboratories, Inc. · May 1981
EBV TEST
K771062 · Gull Laboratories, Inc. · Jul 1977