Cleared Traditional

K012450 - DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST S...

K012450 is the FDA 510(k) clearance for DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST S... by Diamedix Corp.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K012450 · Diamedix Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
86d
Days
Class 2
Risk

K012450 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on October 26, 2001 after a review of 86 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 Diamedix Corp. devices

Submission Details

510(k) Number K012450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2001
Decision Date October 26, 2001
Days to Decision 86 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
18d faster than avg
Panel avg: 104d · This submission: 86d
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 43
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K012450.
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181 · Instrumentation Laboratory CO · Mar 2010
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 SCREEN TEST SYSTEM
K012053 · Diamedix Corp. · Aug 2001
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