Cleared Traditional

K983465 - THE APTUS (AUTOMATED) APPLICATION OF TH...

K983465 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 LKO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K983465 · Zeus Scientific, Inc. · Immunology device
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Nov 1998
Decision
48d
Days
Class 2
Risk

K983465 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME .... Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 48 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 - K983465

510(k) Number K983465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1998
Decision Date November 18, 1998
Days to Decision 48 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
56d faster than avg
Panel avg: 104d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKO Device Classification - Class 2, Special Controls

Product Code LKO Anti-rnp Antibody, Antigen And Control
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 - LKO Anti-rnp Antibody, Antigen And Control

All 8
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K983465.
Maverick RNP Assay and Maverick Diagnostic System
K191085 · Genalyte, Inc. · Oct 2019
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · Cogent Diagnotics , Ltd. · Apr 1999
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · Bio-Rad · Dec 1998
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · Hycor Biomedical, Inc. · Mar 1996
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · Elias U.S.A., Inc. · May 1993
DIASTAT ANTI-LA (SS-B)
K905193 · Shield Diagnostics, Ltd. · Dec 1990