Cleared Traditional

K791928 - ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT

K791928 is an FDA 510(k) clearance for ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT, manufactured by Keith E. Abbott. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K791928 · Keith E. Abbott · Immunology device
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Nov 1979
Decision
47d
Days
Class 2
Risk

K791928 is an FDA 510(k) clearance for the ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Keith E. Abbott (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 47 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.

FDA 510(k) Submission Details - K791928

510(k) Number K791928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1979
Decision Date November 13, 1979
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 105d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K791928.
TEST KIT FOR DETECTION OF ANTINUCLEAR
K802527 · Bartels & Stout, Inc. · Jan 1981
ANATON
K801046 · Armkel, LLC · May 1980
LAB-TEK ANA TEST KIT
K792184 · Miles Laboratories, Inc. · Nov 1979
ANTI NUCLEAR ANTIBODY TEST
K791995 · Meda Stat Diagnostics, Inc. · Oct 1979
ANTI-NUCLEAR ANTIBODY TEST
K791493 · Meloy Laboratories, Inc. · Sep 1979
AUTOANTIBODY REAGENTS, AFT SYSTEM II
K790280 · Calbiochem-Behring Corp. · Apr 1979
K791928 · ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
Download PDF Keith E. Abbott