Cleared Traditional

K944096 - HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

K944096 is an FDA 510(k) clearance for HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM, manufactured by Immuno Concepts, Inc.. The device is a Class 2 Microbiology device with product code DHN cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K944096 · Immuno Concepts, Inc. · Microbiology device
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Nov 1994
Decision
91d
Days
Class 2
Risk

K944096 is an FDA 510(k) clearance for the HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Irving, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5100 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immuno Concepts, Inc. devices

FDA 510(k) Submission Details - K944096

510(k) Number K944096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1994
Decision Date November 21, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 Microbiology 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 K944096.
MICRO21 WITH NDNA
K964165 · Triangle Biomedical Sciences, Inc. · Jan 1997
HEMAGEN ENA DSDNA KIT (EIA METHOD)
K962276 · Hemagen Diagnostics, Inc. · Dec 1996
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
K950979 · Immuno Concepts, Inc. · Jun 1995
DIASTAT ANTI-JO-1 KIT
K912292 · Shield Diagnostics, Ltd. · Jul 1991
HEMAGEN ENA [JO-I] KIT
K902139 · Hemagen Diagnostics, Inc. · May 1990
NOVA LITE(TM) ANA KSL
K901596 · Inova Diagnostics, Inc. · May 1990