Cleared Traditional

K782041 - FIAX TEST KIT

K782041 is the FDA 510(k) clearance for FIAX TEST KIT by Idt, A Division of Whittaker M.A. Bioproducts. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K782041 · Idt, A Division of Whittaker M.A. Bioproducts · Immunology device
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Jan 1979
Decision
27d
Days
Class 2
Risk

K782041 is an FDA 510(k) clearance for the FIAX TEST KIT. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Idt, A Division of Whittaker M.A. Bioproducts (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Idt, A Division of Whittaker M.A. Bioproducts devices

Submission Details

510(k) Number K782041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1978
Decision Date January 03, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 104d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 54
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K782041.
LAB-TEK ANA TEST KIT
K792184 · Miles Laboratories, Inc. · Nov 1979
AUTOANTIBODY REAGENTS, AFT SYSTEM II
K790280 · Calbiochem-Behring Corp. · Apr 1979
TEST KIT, IIF-ANA
K782048 · Medica Corp. · Jan 1979
FLUORESCENT ANTI-NATIVE DNA TEST
K780899 · Kallestad Laboratories, Inc. · Sep 1978
TEST SYS. FOR NDNA ANTIBODY DETERM.
K780178 · Zeus Scientific, Inc. · Feb 1978
IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER
K780161 · Zeus Scientific, Inc. · Feb 1978