Cleared Traditional

K163504 - Borrelia B31 ViraChip IgG Test Kit

K163504 is an FDA 510(k) clearance for Borrelia B31 ViraChip IgG Test Kit, 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 210-day FDA review.

K163504 · Viramed Biotech AG · Microbiology device
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Jul 2017
Decision
210d
Days
Class 2
Risk

K163504 is an FDA 510(k) clearance for the Borrelia B31 ViraChip IgG Test Kit. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Viramed Biotech AG (Planegg, DE). The FDA issued a Cleared decision on July 12, 2017 after a review of 210 days - an extended review 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: 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 - K163504

510(k) Number K163504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2016
Decision Date July 12, 2017
Days to Decision 210 days
Submission Type Traditional
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
108d slower than avg
Panel avg: 102d · This submission: 210d
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 Consultant

Viralab, Inc.
BARRY E. MENEFEE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LSR Reagent, Borrelia Serological Reagent

All 100
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