Cleared Traditional

K935288 - SYNELISA CARDIOLIPIN ANTIBODIES

K935288 is the FDA 510(k) clearance for SYNELISA CARDIOLIPIN 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 82-day FDA review.

K935288 · Elias U.S.A., Inc. · Immunology device
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Jan 1994
Decision
82d
Days
Class 2
Risk

K935288 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 January 24, 1994 after a review of 82 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 Elias U.S.A., Inc. devices

Submission Details

510(k) Number K935288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1993
Decision Date January 24, 1994
Days to Decision 82 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
22d faster than avg
Panel avg: 104d · This submission: 82d
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 K935288.
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
K933788 · Immco Diagnostics, Inc. · Mar 1995
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · Elias U.S.A., Inc. · Sep 1994
HEMAGEN ACL IGA CALIBRATOR
K941840 · Hemagen Diagnostics, Inc. · Jun 1994
ELIAS CARDIOLIPIN IGM ANTIBODIES
K933392 · Elias U.S.A., Inc. · Dec 1993
ELIAS CARDIOLIPIN IGG ANTIBODIES
K933393 · Elias U.S.A., Inc. · Dec 1993
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
K932373 · Hemagen Diagnostics, Inc. · Jul 1993