Cleared Special

K014233 - CAPTIAM SYPHILIS-G ASSAY

K014233 is an FDA 510(k) clearance for CAPTIAM SYPHILIS-G ASSAY, manufactured by Trinity Biotech, Plc. The device is a Class 2 Microbiology device with product code LIP cleared through the Special 510(k) pathway after a 29-day FDA review.

K014233 · Trinity Biotech, Plc · Microbiology device
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Jan 2002
Decision
29d
Days
Class 2
Risk

K014233 is an FDA 510(k) clearance for the CAPTIAM SYPHILIS-G ASSAY. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Trinity Biotech, Plc (Co. Wicklow, IE). The FDA issued a Cleared decision on January 24, 2002 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K014233

510(k) Number K014233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2001
Decision Date January 24, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K014233.
ENZY-WELL SYPHILIS IGG, MODEL 91106
K050590 · Diesse Diagnostica Senese S.P.A. · Aug 2006
TREP-SURE TREPONEMAL ANTIBODY EIA
K053570 · Phoenix Biotech Corp. · Aug 2006
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · DiaSorin, Inc. · Jul 2006
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · Trinity Biotech, Plc · Nov 2000
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552 · Phoenix Biotech Corp. · Oct 2000
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
K014233 · CAPTIAM SYPHILIS-G ASSAY
Download PDF Trinity Biotech, Plc