Cleared Traditional

K790464 - FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO

K790464 is an FDA 510(k) clearance for FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO, manufactured by Intl. Diagnostic Technology. The device is a Class 2 Microbiology device with product code GLZ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K790464 · Intl. Diagnostic Technology · Microbiology device
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Jun 1979
Decision
100d
Days
Class 2
Risk

K790464 is an FDA 510(k) clearance for the FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO. Classified as Antigens, If, Toxoplasma Gondii (product code GLZ), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on June 13, 1979 after a review of 100 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 Intl. Diagnostic Technology devices

FDA 510(k) Submission Details - K790464

510(k) Number K790464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date June 13, 1979
Days to Decision 100 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 102d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GLZ Device Classification - Class 2, Special Controls

Product Code GLZ Antigens, 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.

Regulatory Peers - GLZ Antigens, If, Toxoplasma Gondii

All 8
Devices cleared under the same product code (GLZ) and FDA review panel - the closest regulatory comparables to K790464.
FIAX TOXO-M ANTIBODIES TEST KIT
K850591 · Intl. Diagnostic Technology · Apr 1985
ANTI-TOXOPLASMA GONDII KIT
K842664 · Amico Lab, Inc. · Aug 1984
TOXOPLASMA ANTIBODY TEST SYSTEM
K791571 · Zeus Scientific, Inc. · Sep 1979
QUANTAZYME TOXOPLASMA
K790360 · Bio-Rad · May 1979
IMMUNOZYME TOXOPLASMA ANTIBODY
K780352 · Millipore Corp. · Jun 1978
TOXO TEST
K772243 · Gull Laboratories, Inc. · Dec 1977