Cleared Traditional

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System (K191398) - FDA 510(k) Clearance

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

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

K191398 · Zeus Scientific, Inc. · Microbiology device
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Jul 2019
Decision
66d
Days
Class 2
Risk

K191398 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 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zeus Scientific, Inc. devices

Submission Details

510(k) Number K191398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2019
Decision Date July 29, 2019
Days to Decision 66 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
36d faster than avg
Panel avg: 102d · This submission: 66d
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 36
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K191398.
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
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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
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BioPlex 2200 Lyme Total
K183446 · Bio-Rad Laboratories · Mar 2019
Sofia 2 Lyme FIA, Sofia Lyme Control Set
K173496 · Quidel Corporation · Aug 2018
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K180264 · Gold Standard Diagnostics · May 2018