Cleared Traditional

K141274 - QUANTA FLASH ¿2GP1-DOMAIN1

Also marketed or referenced as:
CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1 CONTROLS.

K141274 is the FDA 510(k) clearance for QUANTA FLASH ¿2GP1-DOMAIN1 by Inova Diagnostics, Inc.. It is a Class 2 Immunology device (product code MSV) cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K141274 · Inova Diagnostics, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 2015
Decision
273d
Days
Class 2
Risk

K141274 is an FDA 510(k) clearance for the QUANTA FLASH ¿2GP1-DOMAIN1. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 13, 2015 after a review of 273 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 Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K141274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2014
Decision Date February 13, 2015
Days to Decision 273 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
169d slower than avg
Panel avg: 104d · This submission: 273d
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 14
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K141274.
Aptiva APS IgA Reagent
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EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K181329 · Phadia AB · Jun 2018
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
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · Instrumentation Laboratory CO · May 2010
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN
K013956 · Diamedix Corp. · Jan 2002
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM
K013628 · Diamedix Corp. · Dec 2001