Cleared Traditional

K091556 - HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I

Also marketed or referenced as:
IGG, IGM, IGG CONTROLS, IGM CONTROLS

K091556 is the FDA 510(k) clearance for HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code MSV) cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K091556 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
359d
Days
Class 2
Risk

K091556 is an FDA 510(k) clearance for the HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 359 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K091556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2009
Decision Date May 21, 2010
Days to Decision 359 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
255d slower than avg
Panel avg: 104d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K091556.
ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
K162788 · Immco Diagnostics, Inc. · Jun 2017
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
K152875 · Inova Diagnostics, Inc. · Dec 2015
QUANTA FLASH ¿2GP1-DOMAIN1
K141274 · Inova Diagnostics, Inc. · Feb 2015
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · Immco Diagnostics, Inc. · Sep 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
K030702 · Immco Diagnostics, Inc. · Sep 2003
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · Diamedix Corp. · Jan 2002