Cleared Traditional

K172244 - EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

K172244 is an FDA 510(k) clearance for EUROIMMUN IFA: Crithidia luciliae (anti..., manufactured by Euroimmun Us, Inc.. The device is a Class 2 Immunology device with product code KTL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

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

FDA 510(k) Submission Details - K172244

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
163d slower than avg
Panel avg: 105d · This submission: 268d
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 12
Devices cleared under the same product code (KTL) and FDA review panel - the closest regulatory comparables to K172244.
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