Cleared Traditional

K002215 - AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ...

K002215 is the FDA 510(k) clearance for AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ... by Cogent Diagnotics , Ltd.. It is a Class 2 Immunology device (product code MOB) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K002215 · Cogent Diagnotics , Ltd. · Immunology device
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Sep 2000
Decision
66d
Days
Class 2
Risk

K002215 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian Eh26 0pl, GB). The FDA issued a Cleared decision on September 28, 2000 after a review of 66 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 Cogent Diagnotics , Ltd. devices

Submission Details

510(k) Number K002215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date September 28, 2000
Days to Decision 66 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: 104d · This submission: 66d
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 37
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K002215.
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM
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K990796 · Cogent Diagnotics , Ltd. · Apr 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
K984516 · Zeus Scientific, Inc. · Jan 1999