Cleared Traditional

K954105 - EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES

K954105 is an FDA 510(k) clearance for EIA KIT FOR THE DETCTION OF ANTI-PR3 AN..., manufactured by Scimedx Corp.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K954105 · Scimedx Corp. · Immunology device
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Mar 1996
Decision
201d
Days
Class 2
Risk

K954105 is an FDA 510(k) clearance for the EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on March 19, 1996 after a review of 201 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 Scimedx Corp. devices

FDA 510(k) Submission Details - K954105

510(k) Number K954105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1995
Decision Date March 19, 1996
Days to Decision 201 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
96d slower than avg
Panel avg: 105d · This submission: 201d
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 59
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K954105.
MPO ELISA TEST SYSTEM
K961765 · Immunoprobe, Inc. · Aug 1996
NOVA LITE ANCA
K961340 · Inova Diagnostics, Inc. · Jul 1996
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
K954062 · Scimedx Corp. · Mar 1996
QUANTA LITE PR3
K955021 · Inova Diagnostics, Inc. · Mar 1996
QUANTA LITE MPO
K955022 · Inova Diagnostics, Inc. · Mar 1996
VARELISA PR3-ANCA
K953586 · Elias U.S.A., Inc. · Jan 1996