Cleared Traditional

K830669 - FIAX COMPLEMENT C4 TEST KIT

K830669 is the FDA 510(k) clearance for FIAX COMPLEMENT C4 TEST KIT by Intl. Diagnostic Technology. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K830669 · Intl. Diagnostic Technology · Immunology device
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Apr 1983
Decision
35d
Days
Class 2
Risk

K830669 is an FDA 510(k) clearance for the FIAX COMPLEMENT C4 TEST KIT. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on April 8, 1983 after a review of 35 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 K830669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1983
Decision Date April 08, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBI Complement C4, 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 - DBI Complement C4, Antigen, Antiserum, Control

All 24
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K830669.
QUANTIMETRIC PLUS C4 REAGENT KIT
K855012 · Kallestad Laboratories, Inc. · Feb 1986
C4 ANTIGEN ANTIBODY CONTROL
K834605 · Technicon Instruments Corp. · Jan 1984
RABBIT ANTISERUM TO HUMAN C4
K831906 · Dako Corp. · Jul 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K801361 · J.T. Baker Chemical Co. · Jun 1980
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K772247 · Kallestad Laboratories, Inc. · Dec 1977