Cleared Traditional

K812968 - FIAX RHEUMATOID FACTOR TEST KIT

K812968 is the FDA 510(k) clearance for FIAX RHEUMATOID FACTOR TEST KIT by Intl. Diagnostic Technology. It is a Class 2 Microbiology device (product code DHR) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K812968 · Intl. Diagnostic Technology · Microbiology device
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Nov 1981
Decision
15d
Days
Class 2
Risk

K812968 is an FDA 510(k) clearance for the FIAX RHEUMATOID FACTOR TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5775 - 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

Submission Details

510(k) Number K812968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1981
Decision Date November 06, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 88
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K812968.
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K812882 · Armkel, LLC · Oct 1981
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K810306 · Beckman Instruments, Inc. · Mar 1981