Cleared Traditional

K051169 - BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT

K051169 is an FDA 510(k) clearance for BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT, manufactured by Viramed Biotech AG. The device is a Class 2 Microbiology device with product code LSR cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K051169 · Viramed Biotech AG · Microbiology device
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Aug 2005
Decision
104d
Days
Class 2
Risk

K051169 is an FDA 510(k) clearance for the BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Viramed Biotech AG (Oceanside, US). The FDA issued a Cleared decision on August 11, 2005 after a review of 104 days - within the typical 510(k) review window.

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 Viramed Biotech AG devices

FDA 510(k) Submission Details - K051169

510(k) Number K051169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2005
Decision Date August 11, 2005
Days to Decision 104 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 102d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSR Device Classification - Class 2, Special Controls

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 64
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K051169.
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K062473 · DiaSorin, Inc. · Apr 2007
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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