Cleared Traditional

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (K172244) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172244 · Euroimmun Us, Inc. · Immunology device
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Apr 2018
Decision
268d
Days
Class 2
Risk

K172244 is an FDA 510(k) clearance for the EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on April 20, 2018 after a review of 268 days - an extended review 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: 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 Euroimmun Us, Inc. devices

Submission Details

510(k) Number K172244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2017
Decision Date April 20, 2018
Days to Decision 268 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
164d slower than avg
Panel avg: 104d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (KTL) and FDA review panel - the closest regulatory comparables to K172244.
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
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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 sensitive (anti-dsDNA) EUROPattern
K172252 · Euroimmun Us, Inc. · Apr 2018