Cleared Traditional

HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY (K001556) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001556 · The Binding Site, Ltd. · Immunology device
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Aug 2000
Decision
95d
Days
Class 2
Risk

K001556 is an FDA 510(k) clearance for the HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on August 21, 2000 after a review of 95 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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K001556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2000
Decision Date August 21, 2000
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 104d · This submission: 95d
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 109
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K001556.
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
K201956 · Zeus Scientific, Inc. · Apr 2022
ImmuGlo HEp-2 Elite IFA
K172745 · Immco Diagnostics, Inc. · Jun 2018
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220 · Bio-Rad · Jan 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
K024217 · Bio-Rad · Jan 2003
LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
K024221 · Bio-Rad · Jan 2003
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
K024222 · Bio-Rad · Jan 2003