Cleared Traditional

THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL (K983418) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983418 · Zeus Scientific, Inc. · Immunology device

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Nov 1998

Decision

50d

Days

Class 2

Risk

K983418 is an FDA 510(k) clearance for the THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTE.... Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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

Submission Details

510(k) Number	K983418 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 29, 1998
Decision Date	November 18, 1998
Days to Decision	50 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

54d faster than avg

Panel avg: 104d · This submission: 50d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DHR System, Test, Rheumatoid Factor
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.5775

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 - DHR System, Test, Rheumatoid Factor

All 39

Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K983418.

COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

K000534 · Roche Diagnostics Corp. · Apr 2000

ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01

K990587 · Bio-Rad · Apr 1999

K990035 · Abbott Laboratories · Mar 1999

QUANTA LITE RF IGG ELISA

K983083 · Inova Diagnostics, Inc. · Nov 1998

QUANTA LITE RF IGA ELISA

K983084 · Inova Diagnostics, Inc. · Nov 1998

QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)

K973464 · Instrumentation Laboratory CO · Oct 1997

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.