Cleared Traditional

K102283 - ZEUS SCIENTIFIC

K102283 is an FDA 510(k) clearance for ZEUS SCIENTIFIC, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K102283 · Zeus Scientific, Inc. · Microbiology device
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Feb 2011
Decision
182d
Days
Class 2
Risk

K102283 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on February 10, 2011 after a review of 182 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. devices

FDA 510(k) Submission Details - K102283

510(k) Number K102283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2010
Decision Date February 10, 2011
Days to Decision 182 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
80d slower than avg
Panel avg: 102d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIP Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K102283.
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
K153730 · Abbott Laboratories · Jun 2016
BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
K120439 · Bio-Rad Laboratories, Inc. · Mar 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361 · Siemens Healthcare Diagnostics · Dec 2009
BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K063866 · Bio-Rad Laboratories · Mar 2007
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · DiaSorin, Inc. · Jul 2006