Cleared Traditional

K924421 - SYNELISA CARDIOLIPIN ANTIBODIES

K924421 is an FDA 510(k) clearance for SYNELISA 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 90-day FDA review.

K924421 · Elias U.S.A., Inc. · Immunology device
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Nov 1992
Decision
90d
Days
Class 2
Risk

K924421 is an FDA 510(k) clearance for the SYNELISA 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 November 30, 1992 after a review of 90 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

FDA 510(k) Submission Details - K924421

510(k) Number K924421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date November 30, 1992
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
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 K924421.
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
QUANTA LITE(TM) IGA ACA
K922351 · Inova Diagnostics, Inc. · Sep 1992
QUANTA LITE ACA SCREEN
K923320 · Inova Diagnostics, Inc. · Sep 1992
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT
K923886 · Shield Diagnostics, Ltd. · Sep 1992