Cleared Traditional

K033106 - CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033106 · Trinity Biotech USA · Microbiology device
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Jul 2004
Decision
287d
Days
Class 2
Risk

K033106 is an FDA 510(k) clearance for the CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT. Classified as Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (product code MYF), Class II - Special Controls.

Submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on July 13, 2004 after a review of 287 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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 USA devices

Submission Details

510(k) Number K033106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date July 13, 2004
Days to Decision 287 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
185d slower than avg
Panel avg: 102d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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 - MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

All 9
Devices cleared under the same product code (MYF) and FDA review panel - the closest regulatory comparables to K033106.
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
K243575 · Biokit, S.A. · Feb 2025
Elecsys HSV-2 IgG (08948887160)
K220924 · Roche Diagnostics · Oct 2022
SeraQuest HSV Type 2 Specific IgG
K181514 · Quest International, Inc. · Jun 2019
ADVIA Centaur Herpes-2 IgG
K181334 · Biokit, S.A. · Aug 2018