Cleared Traditional

K940403 - ELIAS CARDIOLIPIN ANTIBODIES

K940403 is an FDA 510(k) clearance for ELIAS CARDIOLIPIN ANTIBODIES, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K940403 · Elias U.S.A., Inc. · Immunology device
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Sep 1994
Decision
236d
Days
Class 2
Risk

K940403 is an FDA 510(k) clearance for the ELIAS CARDIOLIPIN ANTIBODIES. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 236 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 Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K940403

510(k) Number K940403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1994
Decision Date September 20, 1994
Days to Decision 236 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 105d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MID Device Classification - Class 2, Special Controls

Product Code MID System, Test, Anticardiolipin Immunological
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 - MID System, Test, Anticardiolipin Immunological

All 76
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K940403.
ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)
K933784 · Immco Diagnostics, Inc. · Mar 1995
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST
K933786 · Immco Diagnostics, Inc. · Mar 1995
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
K933788 · Immco Diagnostics, Inc. · Mar 1995
HEMAGEN ACL IGA CALIBRATOR
K941840 · Hemagen Diagnostics, Inc. · Jun 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · Elias U.S.A., Inc. · Jan 1994
ELIAS CARDIOLIPIN IGM ANTIBODIES
K933392 · Elias U.S.A., Inc. · Dec 1993