Cleared Traditional

IMMULISA DSDNA ANTIBODY ELISA (K101319) - FDA 510(k) Clearance

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

K101319 · Immco Diagnostics, Inc. · Immunology device
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Dec 2010
Decision
212d
Days
Class 2
Risk

K101319 is an FDA 510(k) clearance for the IMMULISA DSDNA ANTIBODY ELISA. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on December 9, 2010 after a review of 212 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 K101319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2010
Decision Date December 09, 2010
Days to Decision 212 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 104d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code LRM Anti-dna Antibody (enzyme-labeled), 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K101319.
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
K062183 · The Binding Site, Ltd. · Nov 2006
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K993727 · The Binding Site, Ltd. · Dec 1999
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
K984396 · Bio-Rad · Dec 1998
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
K983422 · Zeus Scientific, Inc. · Nov 1998