Cleared Traditional

K012351 - BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012351 · Becton, Dickinson & CO · Microbiology device
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Sep 2001
Decision
55d
Days
Class 2
Risk

K012351 is an FDA 510(k) clearance for the BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on September 18, 2001 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K012351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2001
Decision Date September 18, 2001
Days to Decision 55 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
47d faster than avg
Panel avg: 102d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSL Dna-reagents, Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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.