Cleared Traditional

K772219 - FIAX TEST FOR ANTI-RUBELLA ANTIBODY

K772219 is the FDA 510(k) clearance for FIAX TEST FOR ANTI-RUBELLA ANTIBODY 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 46-day FDA review.

K772219 · Idt, A Division of Whittaker M.A. Bioproducts · Immunology device
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Jan 1978
Decision
46d
Days
Class 2
Risk

K772219 is an FDA 510(k) clearance for the FIAX TEST FOR ANTI-RUBELLA ANTIBODY. 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 20, 1978 after a review of 46 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 K772219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1977
Decision Date January 20, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 104d · This submission: 46d
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 K772219.
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
IFA ANTI-NDNA
K771376 · Electro-Nucleonics Laboratories, Inc. · Oct 1977
ANA TEST
K771064 · Gull Laboratories, Inc. · Jun 1977
ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP
K760209 · Zeus Scientific, Inc. · Jul 1976