Cleared Traditional

K853484 - INDIRECT ENZYME LINKED IMMUNOSORBENT AS...

K853484 is the FDA 510(k) clearance for INDIRECT ENZYME LINKED IMMUNOSORBENT AS... by Biotech Research Laboratories, Inc.. It is a Class 1 Microbiology device (product code GNP) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K853484 · Biotech Research Laboratories, Inc. · Microbiology device
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Feb 1986
Decision
169d
Days
Class 1
Risk

K853484 is an FDA 510(k) clearance for the INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Biotech Research Laboratories, Inc. (Rockville, US). The FDA issued a Cleared decision on February 5, 1986 after a review of 169 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 Biotech Research Laboratories, Inc. devices

Submission Details

510(k) Number K853484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date February 05, 1986
Days to Decision 169 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 102d · This submission: 169d
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 9
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K853484.
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
ANTI-EPSTEIN-BARR VIRUS KIT
K842662 · Amico Lab, Inc. · Dec 1985
AMIZYME-EBV TEST KIT
K842530 · Amico Lab, Inc. · Dec 1985
ENI ANTIBODY TO EPSTEIN-BARR VIRUS
K810860 · Electro-Nucleonics Laboratories, Inc. · May 1981