Cleared Traditional

K792249 - FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD

K792249 is an FDA 510(k) clearance for FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD, manufactured by Intl. Diagnostic Technology. The device is a Class 2 Microbiology device with product code GOL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K792249 · Intl. Diagnostic Technology · Microbiology device
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Jan 1980
Decision
77d
Days
Class 2
Risk

K792249 is an FDA 510(k) clearance for the FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD. Classified as Antigen, Ha (including Ha Control), Rubella (product code GOL), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intl. Diagnostic Technology devices

FDA 510(k) Submission Details - K792249

510(k) Number K792249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1979
Decision Date January 23, 1980
Days to Decision 77 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
25d faster than avg
Panel avg: 102d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GOL Device Classification - Class 2, Special Controls

Product Code GOL Antigen, Ha (including Ha Control), Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 - GOL Antigen, Ha (including Ha Control), Rubella

All 16
Devices cleared under the same product code (GOL) and FDA review panel - the closest regulatory comparables to K792249.
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
K801098 · Flow Laboratories, Inc. · Sep 1980
ANTIGEN CONTROL CELLS
K801507 · Ortho Diagnostics, Inc. · Aug 1980
MACRO-VUE RUBELLA CARD TEST
K800797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
RUBAZYME
K790976 · Abbott Laboratories · Aug 1979
CORDIA T
K790212 · Cordis Corp. · Apr 1979
CORDIA R
K780885 · Cordis Corp. · Jan 1979