Cleared Traditional

K974167 - WIELISA PR-3 ANCA TEST SYSTEM

K974167 is an FDA 510(k) clearance for WIELISA PR-3 ANCA TEST SYSTEM, manufactured by Wieslab AB. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K974167 · Wieslab AB · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
104d
Days
Class 2
Risk

K974167 is an FDA 510(k) clearance for the WIELISA PR-3 ANCA TEST SYSTEM. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Wieslab AB (Frederick, US). The FDA issued a Cleared decision on February 17, 1998 after a review of 104 days - within the typical 510(k) review window.

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 Wieslab AB devices

FDA 510(k) Submission Details - K974167

510(k) Number K974167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1997
Decision Date February 17, 1998
Days to Decision 104 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 105d · This submission: 104d
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 50
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K974167.
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
K981328 · Inova Diagnostics, Inc. · Jun 1998
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
K981330 · Inova Diagnostics, Inc. · Jun 1998
WIELISA MPO ANCA TEST SYSTEM
K974166 · Wieslab AB · Feb 1998
ORGENTEC ANTI-MPO (P-ANCA) ELISA
K974701 · American Laboratory Products Co., Ltd. · Feb 1998
ORGENTEC ANTI-PR3 (C-ANCA) ELISA
K974702 · American Laboratory Products Co., Ltd. · Feb 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
K974463 · Immuno Concepts, Inc. · Feb 1998