Cleared Traditional

K050625 - VARELISA RECOMBI ANA PROFILE, MODEL 18496

K050625 is an FDA 510(k) clearance for VARELISA RECOMBI ANA PROFILE, manufactured by Sweden Diagnostics (Germany) GmbH. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K050625 · Sweden Diagnostics (Germany) GmbH · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
46d
Days
Class 2
Risk

K050625 is an FDA 510(k) clearance for the VARELISA RECOMBI ANA PROFILE, MODEL 18496. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on April 26, 2005 after a review of 46 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.

FDA 510(k) Submission Details - K050625

510(k) Number K050625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2005
Decision Date April 26, 2005
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 105d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

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 107
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K050625.
ANA SCREEN ELISA (IGG)
K131185 · Euroimmun US · Jul 2013
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188 · Phadia US, Inc. · Mar 2009
VARELISA RECOMBI CTD SCREEN, MODEL 13096
K050967 · Sweden Diagnostics (Germany) GmbH · Jun 2005
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
K041102 · Immco Diagnostics, Inc. · Oct 2004
AESKULISA ANA HEP-2
K040953 · Aesku, Inc. · Jun 2004
VARELISA HISTONE ANTIBODIES, MODEL 16496
K040810 · Pharmacia Deutschland GmbH · May 2004
K050625 · VARELISA RECOMBI ANA PROFILE, MODEL 18496
Download PDF FDA Summary Sweden Diagnostics (G…