Cleared Traditional

K861123 - THE GOLDEN QUAD TEST (CMV) (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861123 · Microbiological Research Corp. · Microbiology device
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Feb 1987
Decision
314d
Days
Class 2
Risk

K861123 is an FDA 510(k) clearance for the THE GOLDEN QUAD TEST (CMV). Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special 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 866.3175 - 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 K861123 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. No clinical trials required.

Device Classification

Product Code GQI Antiserum, Cf, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.