Cleared Traditional

ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM (K093837) - FDA 510(k) Clearance

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

K093837 · Zeus Scientific, Inc. (Zeus) · Microbiology device
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Oct 2010
Decision
290d
Days
Class 2
Risk

K093837 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Zeus) (Raritan, US). The FDA issued a Cleared decision on October 1, 2010 after a review of 290 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 Zeus Scientific, Inc. (Zeus) devices

Submission Details

510(k) Number K093837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2009
Decision Date October 01, 2010
Days to Decision 290 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
188d slower than avg
Panel avg: 102d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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 - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 8
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K093837.
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K153730 · Abbott Laboratories · Jun 2016
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
K102283 · Zeus Scientific, Inc. · Feb 2011
CORDIA S4 -TREPONEMA PALLIDUM
K850329 · Cordis Corp. · Jul 1985