Cleared Traditional

K771064 - ANA TEST

K771064 is an FDA 510(k) clearance for ANA TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K771064 · Gull Laboratories, Inc. · Immunology device
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Jun 1977
Decision
11d
Days
Class 2
Risk

K771064 is an FDA 510(k) clearance for the ANA TEST. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1977 after a review of 11 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 Gull Laboratories, Inc. devices

FDA 510(k) Submission Details - K771064

510(k) Number K771064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1977
Decision Date June 24, 1977
Days to Decision 11 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
94d faster than avg
Panel avg: 105d · This submission: 11d
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 K771064.
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
NDNA IMMUNOPATH FLUORO-KIT
K770057 · Clinical Sciences, Inc. · Apr 1977
TEST, DETECTION, ANTINUCLEAR ANTIBODIES
K760206 · Intl. Diagnostic Technology · Aug 1976
ACID, NATIVE-DEOXYRIBONUCLEIC, IVDP
K760209 · Zeus Scientific, Inc. · Jul 1976