Cleared Traditional

K993085 - AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA

K993085 is the FDA 510(k) clearance for AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA by Cogent Diagnotics , Ltd.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K993085 · Cogent Diagnotics , Ltd. · Immunology device
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Feb 2000
Decision
139d
Days
Class 2
Risk

K993085 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Garden Grove, US). The FDA issued a Cleared decision on February 1, 2000 after a review of 139 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 Cogent Diagnotics , Ltd. devices

Submission Details

510(k) Number K993085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1999
Decision Date February 01, 2000
Days to Decision 139 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
35d slower than avg
Panel avg: 104d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MID System, Test, Anticardiolipin Immunological
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 - MID System, Test, Anticardiolipin Immunological

All 48
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K993085.
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449 · Diamedix Corp. · Oct 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450 · Diamedix Corp. · Oct 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
K012053 · Diamedix Corp. · Aug 2001
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
K992449 · Cogent Diagnotics , Ltd. · Nov 1999
AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
K992440 · Cogent Diagnotics , Ltd. · Sep 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692 · The Binding Site, Ltd. · Feb 1999