Cleared Traditional

K142038 - EUROIMMUN LYME ELISA(IgG/IgM)

K142038 is the FDA 510(k) clearance for EUROIMMUN LYME ELISA(IgG/IgM) by Euroimmun US. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K142038 · Euroimmun US · Microbiology device
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May 2015
Decision
280d
Days
Class 2
Risk

K142038 is an FDA 510(k) clearance for the EUROIMMUN LYME ELISA(IgG/IgM). Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on May 4, 2015 after a review of 280 days - an extended review cycle.

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 devices

Submission Details

510(k) Number K142038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2014
Decision Date May 04, 2015
Days to Decision 280 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
178d slower than avg
Panel avg: 102d · This submission: 280d
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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