Cleared Traditional

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (K181329) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181329 · Phadia AB · Immunology device
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Jun 2018
Decision
38d
Days
Class 2
Risk

K181329 is an FDA 510(k) clearance for the EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on June 25, 2018 after a review of 38 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.

View all Phadia AB devices

Submission Details

510(k) Number K181329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2018
Decision Date June 25, 2018
Days to Decision 38 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
66d faster than avg
Panel avg: 104d · This submission: 38d
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 Consultant

Phadia US, Inc.
Martin Robert Mann

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

All 12
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K181329.
Aptiva APS IgA Reagent
K243979 · Inova Diagnostics, Inc. · Feb 2026
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
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · Instrumentation Laboratory CO · May 2010
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801 · The Binding Site, Ltd. · May 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
K991802 · The Binding Site, Ltd. · May 2000