Cleared Traditional

K140448 - BD PROBETEC NEISSERIA GONORRHOEAE (GC) ...

K140448 is an FDA 510(k) clearance for BD PROBETEC NEISSERIA GONORRHOEAE (GC) ..., manufactured by Becton, Dickinson & CO. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K140448 · Becton, Dickinson & CO · Microbiology device
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May 2014
Decision
88d
Days
Class 2
Risk

K140448 is an FDA 510(k) clearance for the BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX 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 May 20, 2014 after a review of 88 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.

View all Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K140448

510(k) Number K140448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2014
Decision Date May 20, 2014
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LSL Dna-reagents, Neisseria

All 36
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