Cleared Traditional

K981330 - QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT

K981330 is an FDA 510(k) clearance for QUANTA LITE MPO IGG (MYELOPEROXIDASE) T..., manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K981330 · Inova Diagnostics, Inc. · Immunology device
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Jun 1998
Decision
67d
Days
Class 2
Risk

K981330 is an FDA 510(k) clearance for the QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT. 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 June 19, 1998 after a review of 67 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 Inova Diagnostics, Inc. devices

FDA 510(k) Submission Details - K981330

510(k) Number K981330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1998
Decision Date June 19, 1998
Days to Decision 67 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
38d faster than avg
Panel avg: 105d · This submission: 67d
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 62
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K981330.
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
K981029 · The Binding Site, Ltd. · Jul 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
K981030 · The Binding Site, Ltd. · Jul 1998
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
K981328 · Inova Diagnostics, Inc. · Jun 1998
WIELISA MPO ANCA TEST SYSTEM
K974166 · Wieslab AB · Feb 1998
WIELISA PR-3 ANCA TEST SYSTEM
K974167 · Wieslab AB · Feb 1998
ORGENTEC ANTI-MPO (P-ANCA) ELISA
K974701 · American Laboratory Products Co., Ltd. · Feb 1998