Cleared Traditional

K861122 - THE GOLDEN QUAD TEST (TOXO)

K861122 is an FDA 510(k) clearance for THE GOLDEN QUAD TEST (TOXO), manufactured by Microbiological Research Corp.. The device is a Class 2 Microbiology device with product code LJK cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K861122 · Microbiological Research Corp. · Microbiology device
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Feb 1987
Decision
314d
Days
Class 2
Risk

K861122 is an FDA 510(k) clearance for the THE GOLDEN QUAD TEST (TOXO). Classified as Antisera, If, Toxoplasma Gondii (product code LJK), 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 866.3780 - 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

FDA 510(k) Submission Details - K861122

510(k) Number K861122 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.

LJK Device Classification - Class 2, Special Controls

Product Code LJK Antisera, If, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
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.