Cleared Traditional

K040811 - VARELISA SSDNA ANTIBODIES, MODEL 14896

K040811 is an FDA 510(k) clearance for VARELISA SSDNA ANTIBODIES, manufactured by Pharmacia Deutschland GmbH. The device is a Class 2 Immunology device with product code LRM cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K040811 · Pharmacia Deutschland GmbH · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
45d
Days
Class 2
Risk

K040811 is an FDA 510(k) clearance for the VARELISA SSDNA ANTIBODIES, MODEL 14896. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Pharmacia Deutschland GmbH (Freiburg, DE). The FDA issued a Cleared decision on May 13, 2004 after a review of 45 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmacia Deutschland GmbH devices

FDA 510(k) Submission Details - K040811

510(k) Number K040811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2004
Decision Date May 13, 2004
Days to Decision 45 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
60d faster than avg
Panel avg: 105d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 20
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K040811.
IMMULISA DSDNA ANTIBODY ELISA
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DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
K994424 · Diamedix Corp. · Feb 2000
BINDAZYME ANTI-DSDNA EIA KIT
K993727 · The Binding Site, Ltd. · Dec 1999
LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
K984396 · Bio-Rad · Dec 1998