Cleared Traditional

K950979 - HEP-2000 COLORZYME ANA-RO TEST SYSTEM

K950979 is an FDA 510(k) clearance for HEP-2000 COLORZYME ANA-RO TEST SYSTEM, manufactured by Immuno Concepts, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K950979 · Immuno Concepts, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
90d
Days
Class 2
Risk

K950979 is an FDA 510(k) clearance for the HEP-2000 COLORZYME 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 June 1, 1995 after a review of 90 days - within the typical 510(k) review window.

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 Immuno Concepts, Inc. devices

FDA 510(k) Submission Details - K950979

510(k) Number K950979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date June 01, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 105d · This submission: 90d
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 K950979.
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
K970198 · Scimedx Corp. · Feb 1997
MICRO21 WITH NDNA
K964165 · Triangle Biomedical Sciences, Inc. · Jan 1997
HEMAGEN ENA DSDNA KIT (EIA METHOD)
K962276 · Hemagen Diagnostics, Inc. · Dec 1996
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · Immuno Concepts, Inc. · Nov 1994
DIASTAT ANTI-JO-1 KIT
K912292 · Shield Diagnostics, Ltd. · Jul 1991
HEMAGEN ENA [JO-I] KIT
K902139 · Hemagen Diagnostics, Inc. · May 1990