Cleared Traditional

K001556 - HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

K001556 is an FDA 510(k) clearance for HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHN..., manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 95-day FDA review.

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

FDA 510(k) Submission Details - K001556

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 105d · This submission: 95d
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 K001556.
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