Cleared Traditional

K983465 - THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

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
57d faster than avg
Panel avg: 105d · 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 17
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K983465.
VARELISA RNP ANTIBODIES
K993589 · Pharmacia & Upjohn Co. · Nov 1999
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · Cogent Diagnotics , Ltd. · Apr 1999
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · Bio-Rad · Dec 1998
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831 · Orgentec · May 1996
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · Hycor Biomedical, Inc. · Mar 1996
SYNELISA U1-SNRNP (68KDA)-ANTIBODIES
K930142 · Elias U.S.A., Inc. · May 1993