Cleared Traditional

K944171 - VARELISA CENTROMERE ANTIBODIES

K944171 is the FDA 510(k) clearance for VARELISA CENTROMERE ANTIBODIES by Elias U.S.A., Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K944171 · Elias U.S.A., Inc. · Immunology device
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Dec 1994
Decision
118d
Days
Class 2
Risk

K944171 is an FDA 510(k) clearance for the VARELISA CENTROMERE ANTIBODIES. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on December 22, 1994 after a review of 118 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K944171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date December 22, 1994
Days to Decision 118 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
14d slower than avg
Panel avg: 104d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K944171.
VARELISA LA (SS-B) ANTIBODIES
K944168 · Elias U.S.A., Inc. · Dec 1994
VARELISA RO (SS-A) ANTIBODIES
K944169 · Elias U.S.A., Inc. · Dec 1994
VARELISA SM ANTIBODIES
K944170 · Elias U.S.A., Inc. · Dec 1994
VARELISA SCL-70 ANTIBODIES
K944172 · Elias U.S.A., Inc. · Dec 1994
VARELISA JO-1 ANTIBODIES
K944173 · Elias U.S.A., Inc. · Dec 1994
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
K941509 · Bio-Rad · Jun 1994