Cleared Traditional

K062217 - AESKULSKA BETA2-GLYCO-A

K062217 is an FDA 510(k) clearance for AESKULSKA BETA2-GLYCO-A, manufactured by Aesku, Inc.. The device is a Class 2 Immunology device with product code MSV cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K062217 · Aesku, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
134d
Days
Class 2
Risk

K062217 is an FDA 510(k) clearance for the AESKULSKA BETA2-GLYCO-A. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Aesku, Inc. (Miami, US). The FDA issued a Cleared decision on December 13, 2006 after a review of 134 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K062217

510(k) Number K062217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date December 13, 2006
Days to Decision 134 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
29d slower than avg
Panel avg: 105d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSV Device Classification - Class 2, Special Controls

Product Code MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
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 - MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

All 45
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K062217.
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · Instrumentation Laboratory CO · May 2010
THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
K092757 · Thera-Test Laboratories, Inc. · Oct 2009
IGG ANTI-ATHEROX TEST KIT
K072032 · Corgenix, Inc. · Apr 2008
VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
K040449 · Pharmacia Deutschland GmbH · May 2004
VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
K040450 · Pharmacia Deutschland GmbH · May 2004
VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
K040451 · Pharmacia Deutschland GmbH · May 2004
K062217 · AESKULSKA BETA2-GLYCO-A
Download PDF FDA Summary Aesku, Inc.