Cleared Traditional

K092181 - HEMOSIL ACUSTAR CARDIOLIPIN IGG

K092181 is the FDA 510(k) clearance for HEMOSIL ACUSTAR CARDIOLIPIN IGG by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K092181 · Instrumentation Laboratory CO · Immunology device
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Mar 2010
Decision
233d
Days
Class 2
Risk

K092181 is an FDA 510(k) clearance for the HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on March 11, 2010 after a review of 233 days - an extended review 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: 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.

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Submission Details

510(k) Number K092181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2009
Decision Date March 11, 2010
Days to Decision 233 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 104d · This submission: 233d
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 26
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K092181.
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ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
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BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · The Binding Site, Ltd. · Sep 2003
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