Cleared Traditional

K760206 - TEST

K760206 is the FDA 510(k) clearance for TEST by Intl. Diagnostic Technology. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K760206 · Intl. Diagnostic Technology · Immunology device
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Aug 1976
Decision
25d
Days
Class 2
Risk

K760206 is an FDA 510(k) clearance for the TEST, DETECTION, ANTINUCLEAR ANTIBODIES. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on August 3, 1976 after a review of 25 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 Intl. Diagnostic Technology devices

Submission Details

510(k) Number K760206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1976
Decision Date August 03, 1976
Days to Decision 25 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 104d · This submission: 25d
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 55
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K760206.
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
TEST, (IVDP) ANTINUCLEAR ANTIBODY
K760153 · Zeus Scientific, Inc. · Jul 1976