Cleared Traditional

K101319 - IMMULISA DSDNA ANTIBODY ELISA

K101319 is an FDA 510(k) clearance for IMMULISA DSDNA ANTIBODY ELISA, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LRM cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K101319 · Immco Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K101319

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 105d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LRM Device Classification - Class 2, Special Controls

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 24
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K101319.
EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
K083381 · Euroimmun Us, Inc. · Apr 2009
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
K062183 · The Binding Site, Ltd. · Nov 2006
VARELISA SSDNA ANTIBODIES, MODEL 14896
K040811 · Pharmacia Deutschland GmbH · May 2004
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
K001900 · Helix Diagnostics, Inc. · Sep 2000
MDI DS-DNA TEST
K000477 · Micro Detect, Inc. · Mar 2000
DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
K994424 · Diamedix Corp. · Feb 2000