Cleared Traditional

K163695 - Borrelia B31 ViraChip IgM Test Kit

K163695 is an FDA 510(k) clearance for Borrelia B31 ViraChip IgM 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 237-day FDA review.

K163695 · Viramed Biotech AG · Microbiology device
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Aug 2017
Decision
237d
Days
Class 2
Risk

K163695 is an FDA 510(k) clearance for the Borrelia B31 ViraChip IgM 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 August 22, 2017 after a review of 237 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 - K163695

510(k) Number K163695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2016
Decision Date August 22, 2017
Days to Decision 237 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
135d slower than avg
Panel avg: 102d · This submission: 237d
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
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K163695.
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