Cleared Traditional

K830668 - FIAX COMPLEMENT C3 TEST KIT

K830668 is the FDA 510(k) clearance for FIAX COMPLEMENT C3 TEST KIT by Intl. Diagnostic Technology. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K830668 · Intl. Diagnostic Technology · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
32d
Days
Class 2
Risk

K830668 is an FDA 510(k) clearance for the FIAX COMPLEMENT C3 TEST KIT. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - the FDA immunology 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 K830668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date April 05, 1983
Days to Decision 32 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 104d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 Immunology devices follow this clearance model.

Regulatory Peers - CZW Complement C3, Antigen, Antiserum, Control

All 33
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K830668.
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY
K871346 · Dako Corp. · Apr 1987
C3 ANTISERUM CONTROL
K834604 · Technicon Instruments Corp. · Jan 1984
RABBITT ANTISERUM TO HUMAN C3C
K831905 · Dako Corp. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3
K812491 · Dako Corp. · Sep 1981
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K801363 · J.T. Baker Chemical Co. · Jun 1980
COMPLEMENT C3 REAGENT SYSTEM
K800212 · Calbiochem-Behring Corp. · Feb 1980