Cleared Traditional

K042629 - VARELISA SM ANTIBODIES, MODEL 18296

K042629 is an FDA 510(k) clearance for VARELISA SM ANTIBODIES, manufactured by Sweden Diagnostics (Germany) GmbH. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K042629 · Sweden Diagnostics (Germany) GmbH · Immunology device
Download Printable Device Report (PDF)
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Dec 2004
Decision
72d
Days
Class 2
Risk

K042629 is an FDA 510(k) clearance for the VARELISA SM ANTIBODIES, MODEL 18296. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Sweden Diagnostics (Germany) GmbH (Freiburg, DE). The FDA issued a Cleared decision on December 8, 2004 after a review of 72 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 Sweden Diagnostics (Germany) GmbH devices

FDA 510(k) Submission Details - K042629

510(k) Number K042629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date December 08, 2004
Days to Decision 72 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
33d faster than avg
Panel avg: 105d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKP Device Classification - Class 2, Special Controls

Product Code LKP Anti-sm Antibody, Antigen And 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 - LKP Anti-sm Antibody, Antigen And Control

All 20
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K042629.
EIA SMDP IMMUNOASSAY
K132631 · Phadia US, Inc. · Aug 2014
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
K123593 · Inova Diagnostics, Inc. · Apr 2013
THERATEST EL-ANA PROFILES
K051066 · Theratest Laboratories, Inc. · Oct 2005
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · Bio-Rad · Jan 2003
VARELISA SM ANTIBODIES
K000312 · Pharmacia & Upjohn Co. · Mar 2000
AUTOSTAT II ANTI-SM ELISA
K990625 · Cogent Diagnotics , Ltd. · Apr 1999