Cleared Traditional

K961340 - NOVA LITE ANCA

K961340 is the FDA 510(k) clearance for NOVA LITE ANCA by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MOB) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K961340 · Inova Diagnostics, Inc. · Immunology device
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Jul 1996
Decision
107d
Days
Class 2
Risk

K961340 is an FDA 510(k) clearance for the NOVA LITE ANCA. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on July 10, 1996 after a review of 107 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K961340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1996
Decision Date July 10, 1996
Days to Decision 107 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 104d · This submission: 107d
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 35
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K961340.
MYELOPEROXIDASE ELISA TEST SYSTEM
K964446 · Zeus Scientific, Inc. · Apr 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448 · Zeus Scientific, Inc. · Apr 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449 · Zeus Scientific, Inc. · Apr 1997
QUANTA LITE PR3
K955021 · Inova Diagnostics, Inc. · Mar 1996
QUANTA LITE MPO
K955022 · Inova Diagnostics, Inc. · Mar 1996
VARELISA PR3-ANCA
K953586 · Elias U.S.A., Inc. · Jan 1996