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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 33
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K001525.
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
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552 · Phoenix Biotech Corp. · Oct 2000
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317 · Pyramid Biological Corp. · Jun 1996
K001525 · CAPTIA SYPHILIS-G ELISA TEST SYSTEM
Download PDF FDA Summary Trinity Biotech, Plc