Cleared Traditional

K082329 - VIRAMED BIOTECH AG BORRELIA B31 IGM VIR...

K082329 is an FDA 510(k) clearance for VIRAMED BIOTECH AG BORRELIA B31 IGM VIR..., 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 356-day FDA review.

K082329 · Viramed Biotech AG · Microbiology device
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Aug 2009
Decision
356d
Days
Class 2
Risk

K082329 is an FDA 510(k) clearance for the VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE. 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 5, 2009 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K082329

510(k) Number K082329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date August 05, 2009
Days to Decision 356 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
254d slower than avg
Panel avg: 102d · This submission: 356d
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
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