Cleared Traditional

K020758 - VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

K020758 is an FDA 510(k) clearance for VARELISA CARDIOLIPIN IGM ANTIBODIES, manufactured by Pharmacia Deutschland GmbH. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K020758 · Pharmacia Deutschland GmbH · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
56d
Days
Class 2
Risk

K020758 is an FDA 510(k) clearance for the VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Pharmacia Deutschland GmbH (Freiburg, DE). The FDA issued a Cleared decision on May 2, 2002 after a review of 56 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 Pharmacia Deutschland GmbH devices

FDA 510(k) Submission Details - K020758

510(k) Number K020758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2002
Decision Date May 02, 2002
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 105d · This submission: 56d
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 77
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K020758.
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
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K022992 · Corgenix, Inc. · Sep 2002
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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