Cleared Traditional

K864981 - TOXOPLASMA GONDII

K864981 is an FDA 510(k) clearance for TOXOPLASMA GONDII, manufactured by Virion (U.S.), Inc.. The device is a Class 2 Microbiology device with product code GMN cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K864981 · Virion (U.S.), Inc. · Microbiology device
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Oct 1987
Decision
312d
Days
Class 2
Risk

K864981 is an FDA 510(k) clearance for the TOXOPLASMA GONDII. Classified as Antigens, Cf, Toxoplasma Gondii (product code GMN), Class II - Special Controls.

Submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on October 30, 1987 after a review of 312 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 Virion (U.S.), Inc. devices

FDA 510(k) Submission Details - K864981

510(k) Number K864981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date October 30, 1987
Days to Decision 312 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 102d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMN Device Classification - Class 2, Special Controls

Product Code GMN Antigens, Cf, 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.