Cleared Traditional

K050590 - ENZY-WELL SYPHILIS IGG, MODEL 91106

K050590 is an FDA 510(k) clearance for ENZY-WELL SYPHILIS IGG, manufactured by Diesse Diagnostica Senese S.P.A.. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 520-day FDA review.

K050590 · Diesse Diagnostica Senese S.P.A. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
520d
Days
Class 2
Risk

K050590 is an FDA 510(k) clearance for the ENZY-WELL SYPHILIS IGG, MODEL 91106. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Diesse Diagnostica Senese S.P.A. (Miami, US). The FDA issued a Cleared decision on August 10, 2006 after a review of 520 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

FDA 510(k) Submission Details - K050590

510(k) Number K050590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2005
Decision Date August 10, 2006
Days to Decision 520 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
418d slower than avg
Panel avg: 102d · This submission: 520d
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 34
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K050590.
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
K093837 · Zeus Scientific, Inc. (Zeus) · Oct 2010
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
TREP-SURE TREPONEMAL ANTIBODY EIA
K053570 · Phoenix Biotech Corp. · Aug 2006
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · DiaSorin, Inc. · Jul 2006
CAPTIAM SYPHILIS-G ASSAY
K014233 · Trinity Biotech, Plc · Jan 2002
K050590 · ENZY-WELL SYPHILIS IGG, MODEL 91106
Download PDF FDA Summary Diesse Diagnostica Se…