Cleared Traditional

K933392 - ELIAS CARDIOLIPIN IGM ANTIBODIES

K933392 is the FDA 510(k) clearance for ELIAS CARDIOLIPIN IGM ANTIBODIES by Elias U.S.A., Inc.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K933392 · Elias U.S.A., Inc. · Immunology device
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Dec 1993
Decision
149d
Days
Class 2
Risk

K933392 is an FDA 510(k) clearance for the ELIAS CARDIOLIPIN IGM 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 December 8, 1993 after a review of 149 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K933392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date December 08, 1993
Days to Decision 149 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
45d slower than avg
Panel avg: 104d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K933392.
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · Elias U.S.A., Inc. · Sep 1994
HEMAGEN ACL IGA CALIBRATOR
K941840 · Hemagen Diagnostics, Inc. · Jun 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · Elias U.S.A., Inc. · Jan 1994
ELIAS CARDIOLIPIN IGG ANTIBODIES
K933393 · Elias U.S.A., Inc. · Dec 1993
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
K932373 · Hemagen Diagnostics, Inc. · Jul 1993
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
K932225 · Immuno Concepts, Inc. · Jul 1993