Cleared Traditional

K972145 - HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

K972145 is the FDA 510(k) clearance for HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM by Immuno Concepts, Inc.. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K972145 · Immuno Concepts, Inc. · Immunology device
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Feb 1998
Decision
263d
Days
Class 2
Risk

K972145 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. (Sacramento, US). The FDA issued a Cleared decision on February 24, 1998 after a review of 263 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 Immuno Concepts, Inc. devices

Submission Details

510(k) Number K972145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1997
Decision Date February 24, 1998
Days to Decision 263 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
159d slower than avg
Panel avg: 104d · This submission: 263d
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 K972145.
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
K984398 · Bio-Rad · Dec 1998
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
K984399 · Bio-Rad · Dec 1998
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
K984400 · Bio-Rad · Dec 1998
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
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · Immuno Concepts, Inc. · Nov 1994