Cleared Traditional

K974169 - WIELISA ANTI-GBM TEST SYSTEM

K974169 is an FDA 510(k) clearance for WIELISA ANTI-GBM TEST SYSTEM, manufactured by Wieslab AB. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K974169 · Wieslab AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
104d
Days
Class 2
Risk

K974169 is an FDA 510(k) clearance for the WIELISA ANTI-GBM TEST SYSTEM. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), 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 - K974169

510(k) Number K974169 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.

DBL Device Classification - Class 2, Special Controls

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
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 - DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

All 17
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