Cleared Traditional

K231616 - ZEUS IFA(TM) nDNA Test System

K231616 is an FDA 510(k) clearance for ZEUS IFA(TM) nDNA Test System, manufactured by Zeus Scientific. The device is a Class 2 Immunology device with product code KTL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K231616 · Zeus Scientific · Immunology device
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Aug 2023
Decision
90d
Days
Class 2
Risk

K231616 is an FDA 510(k) clearance for the ZEUS IFA(TM) nDNA Test System, ZEUS dIFine. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on August 31, 2023 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific devices

FDA 510(k) Submission Details - K231616

510(k) Number K231616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2023
Decision Date August 31, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTL Device Classification - Class 2, Special Controls

Product Code KTL Anti-dna Indirect Immunofluorescent Solid Phase
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 - KTL Anti-dna Indirect Immunofluorescent Solid Phase

All 11
Devices cleared under the same product code (KTL) and FDA review panel - the closest regulatory comparables to K231616.
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
K203599 · Immuno Concepts, N.A. , Ltd. · May 2023
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
K192916 · Inova Diagnostics, Inc. · Dec 2020
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
K172244 · Euroimmun Us, Inc. · Apr 2018
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
K172252 · Euroimmun Us, Inc. · Apr 2018
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
K013432 · Immuno Concepts, Inc. · Nov 2001
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
K930987 · The Binding Site, Ltd. · Aug 1993