Cleared Traditional

K780899 - FLUORESCENT ANTI-NATIVE DNA TEST

K780899 is an FDA 510(k) clearance for FLUORESCENT ANTI-NATIVE DNA TEST, manufactured by Kallestad Laboratories, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K780899 · Kallestad Laboratories, Inc. · Immunology device
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Sep 1978
Decision
97d
Days
Class 2
Risk

K780899 is an FDA 510(k) clearance for the FLUORESCENT ANTI-NATIVE DNA TEST. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kallestad Laboratories, Inc. devices

FDA 510(k) Submission Details - K780899

510(k) Number K780899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1978
Decision Date September 07, 1978
Days to Decision 97 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
8d faster than avg
Panel avg: 105d · This submission: 97d
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 70
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K780899.
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
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