Cleared Traditional

K983420 - THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO

K983420 is an FDA 510(k) clearance for THE APTUS(AUTOMATED)APPLICATION OF THE ..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K983420 · Zeus Scientific, Inc. · Immunology device
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Nov 1998
Decision
50d
Days
Class 2
Risk

K983420 is an FDA 510(k) clearance for the THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IM.... Classified as Anti-sm Antibody, Antigen And Control (product code LKP), 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 866.5100 - 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 - K983420

510(k) Number K983420 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
55d faster than avg
Panel avg: 105d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKP Device Classification - Class 2, Special Controls

Product Code LKP Anti-sm 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 - LKP Anti-sm Antibody, Antigen And Control

All 21
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K983420.
VARELISA SM ANTIBODIES
K000312 · Pharmacia & Upjohn Co. · Mar 2000
AUTOSTAT II ANTI-SM ELISA
K990625 · Cogent Diagnotics , Ltd. · Apr 1999
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · Bio-Rad · Dec 1998
SERAQUEST ANTI-SM
K980540 · Quest Intl., Inc. · Jun 1998
SERAQUEST ANTI-SM/RNP
K980811 · Quest Intl., Inc. · May 1998
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830 · Orgentec · May 1996