Cleared Traditional

K091845 - CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL ...

K091845 is an FDA 510(k) clearance for CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL ..., manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K091845 · Phadia US, Inc. · Immunology device
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Jun 2010
Decision
350d
Days
Class 2
Risk

K091845 is an FDA 510(k) clearance for the CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Cleared decision on June 7, 2010 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Phadia US, Inc. devices

FDA 510(k) Submission Details - K091845

510(k) Number K091845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2009
Decision Date June 07, 2010
Days to Decision 350 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
246d slower than avg
Panel avg: 104d · This submission: 350d
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 72
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K091845.
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K103834 · Bio-Rad Laboratories · Mar 2012
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425 · Zeus Scientific, Inc. · Dec 2011
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181 · Instrumentation Laboratory CO · Mar 2010
EL-ACL SCREEN
K060176 · Theratest Laboratories, Inc. · Feb 2006
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
K032868 · Corgenix, Inc. · Oct 2003