Cleared Traditional

K944334 - VARELISA COMBINED DNA ANTIBODIES EIA

K944334 is an FDA 510(k) clearance for VARELISA COMBINED DNA ANTIBODIES EIA, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code LRM cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K944334 · Elias U.S.A., Inc. · Immunology device
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Apr 1995
Decision
223d
Days
Class 2
Risk

K944334 is an FDA 510(k) clearance for the VARELISA COMBINED DNA ANTIBODIES EIA. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on April 17, 1995 after a review of 223 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 Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K944334

510(k) Number K944334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1994
Decision Date April 17, 1995
Days to Decision 223 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 105d · This submission: 223d
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 19
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K944334.
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
K960091 · Helix Diagnostics, Inc. · Mar 1996
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
K960182 · Mardx Diagnostics, Inc. · Mar 1996
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
K952055 · American Laboratory Products Co., Ltd. · Jul 1995
VARELISA DSDNA ANTIBODIES (FARR VERSION)
K950031 · Elias U.S.A., Inc. · Mar 1995
ANTI-DNA MICROASSAY
K912020 · Diamedix Corp. · Sep 1991
UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE
K902897 · United Biotech, Inc. · Jul 1990