Cleared Special

K052481 - BD VIPER SYSTEM

K052481 is an FDA 510(k) clearance for BD VIPER SYSTEM, manufactured by Becton, Dickinson & CO. The device is a Class 2 Microbiology device with product code LSL cleared through the Special 510(k) pathway after a 80-day FDA review.

K052481 · Becton, Dickinson & CO · Microbiology device
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Nov 2005
Decision
80d
Days
Class 2
Risk

K052481 is an FDA 510(k) clearance for the BD VIPER SYSTEM. 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 November 28, 2005 after a review of 80 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K052481

510(k) Number K052481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date November 28, 2005
Days to Decision 80 days
Submission Type Special
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
22d faster than avg
Panel avg: 102d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K052481.
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
K061509 · Gen-Probe, Inc. · Oct 2006
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
K060652 · Gen-Probe, Inc. · Aug 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · Roche Diagnostics Corp. · Aug 2006
BD PROBE TEC URINE PRESERVATIVE TRANSPORT
K052224 · Becton, Dickinson & CO · Sep 2005
GEN-PROBE APTIMA COMBO 2 ASSAY
K043224 · Gen-Probe, Inc. · Aug 2005
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144 · Gen-Probe, Inc. · Mar 2005