Cleared Traditional

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System (K190907) - FDA 510(k) Clearance

Also marketed or referenced as:
ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System

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

K190907 · Zeus Scientific, Inc. · Microbiology device
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Jul 2019
Decision
112d
Days
Class 2
Risk

K190907 is an FDA 510(k) clearance for the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on July 29, 2019 after a review of 112 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 Zeus Scientific, Inc. devices

Submission Details

510(k) Number K190907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2019
Decision Date July 29, 2019
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
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 34
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K190907.
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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System
K191398 · Zeus Scientific, Inc. · Jul 2019
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K183446 · Bio-Rad Laboratories · Mar 2019