Cleared Traditional

K061247 - DIASORIN LIAISON TREPONEMA ASSAY

K061247 is the FDA 510(k) clearance for DIASORIN LIAISON TREPONEMA ASSAY by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LIP) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K061247 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
89d
Days
Class 2
Risk

K061247 is an FDA 510(k) clearance for the DIASORIN LIAISON TREPONEMA ASSAY. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on July 31, 2006 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K061247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2006
Decision Date July 31, 2006
Days to Decision 89 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
13d faster than avg
Panel avg: 102d · This submission: 89d
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 18
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K061247.
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
K102283 · Zeus Scientific, Inc. · Feb 2011
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
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1991
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1990