Cleared Traditional

K992440 - AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA

K992440 is an FDA 510(k) clearance for AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA, manufactured by Cogent Diagnotics , Ltd.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K992440 · Cogent Diagnotics , Ltd. · Immunology device
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Sep 1999
Decision
61d
Days
Class 2
Risk

K992440 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on September 21, 1999 after a review of 61 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

FDA 510(k) Submission Details - K992440

510(k) Number K992440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1999
Decision Date September 21, 1999
Days to Decision 61 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
44d faster than avg
Panel avg: 105d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

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 76
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K992440.
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K993085 · Cogent Diagnotics , Ltd. · Feb 2000
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K984102 · Louisville Apl Diagnostics, Inc. · Mar 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692 · The Binding Site, Ltd. · Feb 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
K983694 · The Binding Site, Ltd. · Feb 1999