Cleared Traditional

K974463 - IMMUNO CONCEPTS ANCA TEST SYSTEM

K974463 is the FDA 510(k) clearance for IMMUNO CONCEPTS ANCA TEST SYSTEM by Immuno Concepts, Inc.. It is a Class 2 Immunology device (product code MOB) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K974463 · Immuno Concepts, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
75d
Days
Class 2
Risk

K974463 is an FDA 510(k) clearance for the IMMUNO CONCEPTS ANCA TEST SYSTEM. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Dallas, US). The FDA issued a Cleared decision on February 9, 1998 after a review of 75 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 Immuno Concepts, Inc. devices

Submission Details

510(k) Number K974463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1997
Decision Date February 09, 1998
Days to Decision 75 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
29d faster than avg
Panel avg: 104d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K974463.
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
K981330 · Inova Diagnostics, Inc. · Jun 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 SYSTEMS
K974478 · Immuno Concepts, Inc. · Feb 1998
VIRGO ANCA SCREEN KIT
K973822 · Hemagen Diagnostics, Inc. · Nov 1997
PR 3 ANTIBODY KIT
K973823 · Hemagen Diagnostics, Inc. · Nov 1997