Cleared Traditional

K981020 - ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM

K981020 is an FDA 510(k) clearance for ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code MID cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K981020 · Zeus Scientific, Inc. · Immunology device
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May 1998
Decision
60d
Days
Class 2
Risk

K981020 is an FDA 510(k) clearance for the ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 18, 1998 after a review of 60 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K981020

510(k) Number K981020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1998
Decision Date May 18, 1998
Days to Decision 60 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
44d faster than avg
Panel avg: 104d · This submission: 60d
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 54
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K981020.
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
K984347 · Zeus Scientific, Inc. · Dec 1998
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
K981014 · Zeus Scientific, Inc. · Jun 1998
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
K981021 · Zeus Scientific, Inc. · Jun 1998
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
K973196 · Zeus Scientific, Inc. · Oct 1997
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784 · Zeus Scientific, Inc. · Jul 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
K970177 · Immco Diagnostics, Inc. · Jun 1997