Cleared Traditional

K981748 - WIELISA ANCA SCREENING KIT TEST SYSTEM

K981748 is an FDA 510(k) clearance for WIELISA ANCA SCREENING KIT 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 65-day FDA review.

K981748 · Wieslab AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
65d
Days
Class 2
Risk

K981748 is an FDA 510(k) clearance for the WIELISA ANCA SCREENING KIT 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 July 22, 1998 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wieslab AB devices

FDA 510(k) Submission Details - K981748

510(k) Number K981748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date July 22, 1998
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 105d · This submission: 65d
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 51
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