Cleared Traditional

K001525 - CAPTIA SYPHILIS-G ELISA TEST SYSTEM

K001525 is an FDA 510(k) clearance for CAPTIA SYPHILIS-G ELISA TEST SYSTEM, manufactured by Trinity Biotech, Plc. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K001525 · Trinity Biotech, Plc · Microbiology device
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Nov 2000
Decision
197d
Days
Class 2
Risk

K001525 is an FDA 510(k) clearance for the CAPTIA SYPHILIS-G ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Trinity Biotech, Plc (Jamestown, US). The FDA issued a Cleared decision on November 29, 2000 after a review of 197 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 Trinity Biotech, Plc devices

FDA 510(k) Submission Details - K001525

510(k) Number K001525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2000
Decision Date November 29, 2000
Days to Decision 197 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 102d · This submission: 197d
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 23
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K001525.
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
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