Cleared Traditional

K943812 - VIDAS LYME SCREEN II

K943812 is an FDA 510(k) clearance for VIDAS LYME SCREEN II, manufactured by Biomerieux Vitek, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K943812

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.

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 97
Devices cleared under the same product code (LSR) and FDA review panel - the closest regulatory comparables to K943812.
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