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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 93
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K020758.
QACA IGG/IGM ELISA KIT HRP
K021192 · Cheshire Diagnostics , Ltd. · May 2002
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
K020752 · Pharmacia Deutschland GmbH · May 2002
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
K020757 · Pharmacia Deutschland GmbH · May 2002
QACA IGG/IGM ELISA KIT
K020241 · Cheshire Diagnostics , Ltd. · Mar 2002
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
K020156 · Axis-Shield Diagnostics, Ltd. · Mar 2002
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449 · Diamedix Corp. · Oct 2001
K020758 · VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
Download PDF FDA Summary Pharmacia Deutschland…