Cleared Traditional

K760681 - INDIRECT FLUORESCENT (IFA-ANA)

K760681 is an FDA 510(k) clearance for INDIRECT FLUORESCENT (IFA-ANA), manufactured by Wampole Laboratories. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K760681 · Wampole Laboratories · Immunology device
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Oct 1976
Decision
31d
Days
Class 2
Risk

K760681 is an FDA 510(k) clearance for the INDIRECT FLUORESCENT (IFA-ANA). Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Wampole Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 21, 1976 after a review of 31 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 Wampole Laboratories devices

FDA 510(k) Submission Details - K760681

510(k) Number K760681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1976
Decision Date October 21, 1976
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 105d · This submission: 31d
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 72
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K760681.
IFA ANTI-NDNA
K771376 · Electro-Nucleonics Laboratories, Inc. · Oct 1977
ANA TEST
K771064 · Gull Laboratories, Inc. · Jun 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
TEST, (IVDP) ANTINUCLEAR ANTIBODY
K760153 · Zeus Scientific, Inc. · Jul 1976