Cleared Traditional

K861121 - THE GOLDEN QUAD TEST (EBV)

K861121 is the FDA 510(k) clearance for THE GOLDEN QUAD TEST (EBV) by Microbiological Research Corp.. It is a Class 1 Microbiology device (product code GNP) cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K861121 · Microbiological Research Corp. · Microbiology device
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Feb 1987
Decision
314d
Days
Class 1
Risk

K861121 is an FDA 510(k) clearance for the THE GOLDEN QUAD TEST (EBV). Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Microbiological Research Corp. (Bountiful, US). The FDA issued a Cleared decision on February 2, 1987 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Microbiological Research Corp. devices

Submission Details

510(k) Number K861121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1986
Decision Date February 02, 1987
Days to Decision 314 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 102d · This submission: 314d
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 K861121.
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