Cleared Traditional

IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA (K041102) - FDA 510(k) Clearance

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

K041102 · Immco Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
182d
Days
Class 2
Risk

K041102 is an FDA 510(k) clearance for the IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 26, 2004 after a review of 182 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 Immco Diagnostics, Inc. devices

Submission Details

510(k) Number K041102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2004
Decision Date October 26, 2004
Days to Decision 182 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
78d slower than avg
Panel avg: 104d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 12
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K041102.
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K182353 · Phadia AB · Nov 2018
QUANTA FLASH CENTROMERE
K123880 · Inova Diagnostics, Inc. · Feb 2014
ANA EIA DIAGNOSTIC TEST KIT
K004019 · The Binding Site, Ltd. · Feb 2001
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
K003959 · Inova Diagnostics, Inc. · Jan 2001
THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K000879 · Zeus Scientific, Inc. · May 2000
THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K000880 · Zeus Scientific, Inc. · May 2000