Cleared Traditional

K033083 - BORRELIA BURGDORFERI IGG/IGM ELISA TEST...

K033083 is the FDA 510(k) clearance for BORRELIA BURGDORFERI IGG/IGM ELISA TEST... by Trinity Biotech USA. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K033083 · Trinity Biotech USA · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
58d
Days
Class 2
Risk

K033083 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 58 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 Trinity Biotech USA devices

Submission Details

510(k) Number K033083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 26, 2003
Days to Decision 58 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
44d faster than avg
Panel avg: 102d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSR Reagent, Borrelia Serological Reagent
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 - LSR Reagent, Borrelia Serological Reagent

All 51
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K033083.
PLATELIA LYME IGM
K081362 · Bio-Rad · Jun 2008
PLATELIA LYME IGG ASSAY
K080012 · Bio-Rad · May 2008
LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870
K062473 · DiaSorin, Inc. · Apr 2007
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
K994004 · Inova Diagnostics, Inc. · Jan 2000
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
K991180 · Zeus Scientific, Inc. · Sep 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185 · Zeus Scientific, Inc. · Sep 1999