Cleared Traditional

K983422 - THE APTUS (AUTOMATED) APPLICATIONS OF T...

K983422 is an FDA 510(k) clearance for THE APTUS (AUTOMATED) APPLICATIONS OF T..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code LRM cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K983422 · Zeus Scientific, Inc. · Immunology device
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Nov 1998
Decision
50d
Days
Class 2
Risk

K983422 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IM.... Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), 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 - K983422

510(k) Number K983422 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
54d faster than avg
Panel avg: 104d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRM Device Classification - Class 2, Special Controls

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 14
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K983422.
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K984396 · Bio-Rad · Dec 1998
IS-DSDNA TEST SYSTEM
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HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
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AUTOSTATTMII ANTI-DSDNA
K952567 · Cogent Diagnotics , Ltd. · Mar 1997