Cleared Traditional

K953586 - VARELISA PR3-ANCA

K953586 is an FDA 510(k) clearance for VARELISA PR3-ANCA, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K953586 · Elias U.S.A., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
178d
Days
Class 2
Risk

K953586 is an FDA 510(k) clearance for the VARELISA PR3-ANCA. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 178 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 - K953586

510(k) Number K953586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date January 26, 1996
Days to Decision 178 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
73d slower than avg
Panel avg: 105d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 65
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K953586.
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
K954105 · Scimedx Corp. · Mar 1996
QUANTA LITE PR3
K955021 · Inova Diagnostics, Inc. · Mar 1996
QUANTA LITE MPO
K955022 · Inova Diagnostics, Inc. · Mar 1996
VARELISA MPO-ANCA
K953587 · Elias U.S.A., Inc. · Jan 1996
DIASTAT ANTI-PR3 (C-ANCA) KIT
K942813 · Shield Diagnostics, Ltd. · Mar 1995
DIASTAT ANTI-MPO (PANCA) KIT
K943630 · Shield Diagnostics, Ltd. · Mar 1995