Cleared Traditional

K230863 - ZEUS Solinas Borrelia VlsE1/pepC10 IgG/...

Also marketed or referenced as:
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

K230863 is an FDA 510(k) clearance for ZEUS Solinas Borrelia VlsE1/pepC10 IgG/..., manufactured by Zeus Scientific. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K230863 · Zeus Scientific · Microbiology device
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Jul 2023
Decision
106d
Days
Class 2
Risk

K230863 is an FDA 510(k) clearance for the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on July 13, 2023 after a review of 106 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 devices

FDA 510(k) Submission Details - K230863

510(k) Number K230863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2023
Decision Date July 13, 2023
Days to Decision 106 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
4d slower than avg
Panel avg: 102d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSR Device Classification - Class 2, Special Controls

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 63
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