Cleared Traditional

K162788 - ImmuLisa Enhanced B2GP1 IgA Antibody ELISA

K162788 is an FDA 510(k) clearance for ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MSV cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K162788 · Immco Diagnostics, Inc. · Immunology device
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Jun 2017
Decision
259d
Days
Class 2
Risk

K162788 is an FDA 510(k) clearance for the ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antib.... Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on June 19, 2017 after a review of 259 days - an extended review 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: 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.

View all Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K162788

510(k) Number K162788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2016
Decision Date June 19, 2017
Days to Decision 259 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
155d slower than avg
Panel avg: 104d · This submission: 259d
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 35
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K162788.
Aptiva APS IgA Reagent
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EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
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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
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414 · Phadia US, Inc. · Jun 2012
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · Instrumentation Laboratory CO · May 2010