Cleared Traditional

K100728 - ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC1...

K100728 is an FDA 510(k) clearance for ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC1..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K100728 · Zeus Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
113d
Days
Class 2
Risk

K100728 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on July 6, 2010 after a review of 113 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

FDA 510(k) Submission Details - K100728

510(k) Number K100728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2010
Decision Date July 06, 2010
Days to Decision 113 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 102d · This submission: 113d
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 59
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K100728.
Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
K173691 · Quidel Corporation · Feb 2018
Sofia Lyme FIA, Sofia Lyme Control Set
K163713 · Quidel Corporation · Oct 2017
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
K113397 · Zeus Scientific, Inc. · Jul 2012
PLATELIA LYME IGM
K081362 · Bio-Rad · Jun 2008
PLATELIA LYME IGG ASSAY
K080012 · Bio-Rad · May 2008
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · DiaSorin, Inc. · Apr 2007