Cleared Traditional

K983740 - IS-ANTI-PR3 IGG ELISA TEST SYSTEM

K983740 is an FDA 510(k) clearance for IS-ANTI-PR3 IGG ELISA TEST SYSTEM, manufactured by Columbia Bioscience, Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K983740 · Columbia Bioscience, Inc. · Immunology device
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Nov 1998
Decision
27d
Days
Class 2
Risk

K983740 is an FDA 510(k) clearance for the IS-ANTI-PR3 IGG ELISA TEST SYSTEM. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 27 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 Columbia Bioscience, Inc. devices

FDA 510(k) Submission Details - K983740

510(k) Number K983740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date November 18, 1998
Days to Decision 27 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
78d faster than avg
Panel avg: 105d · This submission: 27d
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 54
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K983740.
IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
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THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K984034 · Zeus Scientific, Inc. · Nov 1998
IS-ANTI-MPO IGG ELISA TEST SYSTEM
K983390 · Columbia Bioscience, Inc. · Nov 1998
WIELISA ANCA SCREENING KIT TEST SYSTEM
K981748 · Wieslab AB · Jul 1998
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
K981750 · Wieslab AB · Jul 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
K981029 · The Binding Site, Ltd. · Jul 1998