Cleared Traditional

K990796 - AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA

K990796 is the FDA 510(k) clearance for AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA by Cogent Diagnotics , Ltd.. It is a Class 2 Immunology device (product code MOB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K990796 · Cogent Diagnotics , Ltd. · Immunology device
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Apr 1999
Decision
49d
Days
Class 2
Risk

K990796 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on April 28, 1999 after a review of 49 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 K990796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date April 28, 1999
Days to Decision 49 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
55d faster than avg
Panel avg: 104d · This submission: 49d
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 K990796.
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THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
K984315 · Zeus Scientific, Inc. · Dec 1998
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K982898 · Immco Diagnostics, Inc. · Nov 1998