Cleared Traditional

K984034 - THE APTUS (AUTOMATED) APPLICATION OF TH...

K984034 is an FDA 510(k) clearance for THE APTUS (AUTOMATED) APPLICATION OF TH..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K984034 · Zeus Scientific, Inc. · Immunology device

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Nov 1998

Decision

18d

Days

Class 2

Risk

K984034 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN EN.... Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on November 30, 1998 after a review of 18 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 - K984034

510(k) Number	K984034 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 12, 1998
Decision Date	November 30, 1998
Days to Decision	18 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

86d faster than avg

Panel avg: 104d · This submission: 18d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

Product Code	MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
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 - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 41

Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K984034.

THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET

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THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE

K984315 · Zeus Scientific, Inc. · Dec 1998

IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM

K982898 · Immco Diagnostics, Inc. · Nov 1998

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K981029 · The Binding Site, Ltd. · Jul 1998

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K981030 · The Binding Site, Ltd. · Jul 1998

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K981328 · Inova Diagnostics, Inc. · Jun 1998

FDA 510(k) Resources - Immunology

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