Cleared Traditional

TOXOGEN (K913467) - FDA 510(k) Clearance

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

K913467 · Biokit USA, Inc. · Microbiology device
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Jan 1993
Decision
525d
Days
Class 2
Risk

K913467 is an FDA 510(k) clearance for the TOXOGEN. Classified as Direct Agglutination Test, Toxoplasma Gondii (product code LLA), Class II - Special Controls.

Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on January 11, 1993 after a review of 525 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Biokit USA, Inc. devices

Submission Details

510(k) Number K913467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date January 11, 1993
Days to Decision 525 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
423d slower than avg
Panel avg: 102d · This submission: 525d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLA Direct Agglutination Test, 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.