Cleared Traditional

K983378 - THE APTUS (AUTOMATED) APPLICATION OF TH...

K983378 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 LJM cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K983378 · Zeus Scientific, Inc. · Immunology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Nov 1998

Decision

54d

Days

Class 2

Risk

K983378 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZ.... Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), 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 54 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 - K983378

510(k) Number	K983378 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 25, 1998
Decision Date	November 18, 1998
Days to Decision	54 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

50d faster than avg

Panel avg: 104d · This submission: 54d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code	LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.5100

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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 50

Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K983378.

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

K000880 · Zeus Scientific, Inc. · May 2000

RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11

K992041 · Immuno Concepts, Inc. · Jul 1999

AUTOSTAT II ANA SCREEN ELISA

K983655 · Cogent Diagnotics , Ltd. · Jan 1999

ELIAS ANA-HEP-2

K964385 · Elias U.S.A., Inc. · Mar 1997

HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE

K962450 · Hycor Biomedical, Inc. · Nov 1996

ORGENTEC ANTI-RNP/SM ELISA

K962057 · American Laboratory Products Co., Ltd. · Nov 1996

FDA 510(k) Resources - Immunology

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