Cleared Traditional

K962276 - HEMAGEN ENA DSDNA KIT (EIA METHOD)

K962276 is the FDA 510(k) clearance for HEMAGEN ENA DSDNA KIT (EIA METHOD) by Hemagen Diagnostics, Inc.. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K962276 · Hemagen Diagnostics, Inc. · Immunology device
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Dec 1996
Decision
175d
Days
Class 2
Risk

K962276 is an FDA 510(k) clearance for the HEMAGEN ENA DSDNA KIT (EIA METHOD). Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on December 5, 1996 after a review of 175 days - an extended review 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: 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 Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K962276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1996
Decision Date December 05, 1996
Days to Decision 175 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 104d · This submission: 175d
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 51
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K962276.
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
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LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
K984400 · Bio-Rad · Dec 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145 · Immuno Concepts, Inc. · Feb 1998
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
K950979 · Immuno Concepts, Inc. · Jun 1995
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · Immuno Concepts, Inc. · Nov 1994
HEMAGEN ENA [JO-I] KIT
K902139 · Hemagen Diagnostics, Inc. · May 1990