Cleared Traditional

K943812 - VIDAS LYME SCREEN II

K943812 is the FDA 510(k) clearance for VIDAS LYME SCREEN II by Biomerieux Vitek, Inc.. It is a Class 2 Microbiology device (product code LSR) cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K943812 · Biomerieux Vitek, Inc. · Microbiology device
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Jun 1995
Decision
312d
Days
Class 2
Risk

K943812 is an FDA 510(k) clearance for the VIDAS LYME SCREEN II. Classified as Reagent, Borrelia Serological Reagent (product code LSR), Class II - Special Controls.

Submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 312 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 Biomerieux Vitek, Inc. devices

Submission Details

510(k) Number K943812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1994
Decision Date June 13, 1995
Days to Decision 312 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 102d · This submission: 312d
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 50
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