Cleared Traditional

TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN (K894261) - FDA 510(k) Clearance

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

K894261 · Microbix Biosystems, Inc. · Microbiology device
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Oct 1989
Decision
117d
Days
Class 2
Risk

K894261 is an FDA 510(k) clearance for the TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN. Classified as Antigens, Cf, Toxoplasma Gondii (product code GMN), Class II - Special Controls.

Submitted by Microbix Biosystems, Inc. (Flemington, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 117 days - within the typical 510(k) review window.

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. 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 Microbix Biosystems, Inc. devices

Submission Details

510(k) Number K894261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date October 16, 1989
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 102d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.