Cleared Traditional

K022800 - VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM

K022800 is an FDA 510(k) clearance for VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM, manufactured by Hyperion, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K022800 · Hyperion, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
94d
Days
Class 2
Risk

K022800 is an FDA 510(k) clearance for the VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Hyperion, Inc. (Miami, US). The FDA issued a Cleared decision on November 25, 2002 after a review of 94 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 Hyperion, Inc. devices

FDA 510(k) Submission Details - K022800

510(k) Number K022800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2002
Decision Date November 25, 2002
Days to Decision 94 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 105d · This submission: 94d
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 72
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K022800.
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
K024229 · Bio-Rad · Jan 2003
LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
K024230 · Bio-Rad · Jan 2003
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
K024231 · Bio-Rad · Jan 2003
POLYTITER SYSTEM
K012163 · Polymedco, Inc. · Aug 2001
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
K001556 · The Binding Site, Ltd. · Aug 2000
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
K990915 · Stellar Bio Systems, Inc. · Apr 1999