Cleared Traditional

K172722 - Anti-Borrelia burgdorferi US EUROLINE-W...

K172722 is the FDA 510(k) clearance for Anti-Borrelia burgdorferi US EUROLINE-W... by Euroimmun Us, Inc.. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K172722 · Euroimmun Us, Inc. · Microbiology device
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Dec 2017
Decision
90d
Days
Class 2
Risk

K172722 is an FDA 510(k) clearance for the Anti-Borrelia burgdorferi US EUROLINE-WB (IgM). Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on December 10, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Euroimmun Us, Inc. devices

Submission Details

510(k) Number K172722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2017
Decision Date December 10, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSR Reagent, Borrelia Serological Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 Microbiology devices follow this clearance model.

Regulatory Peers - LSR Reagent, Borrelia Serological Reagent

All 51
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