Telavancin 30 Ug, Bbl Sensi-Disc
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100722 FDA 510(k)
- FDA Product Code
- JTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1620 FDA 510(k)
- Regulation Number
- 866.1620 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Telavancin 30 µg BBL Sensi-Disc is an antimicrobial susceptibility test disc used for in vitro agar diffusion testing. It is designed to determine bacterial susceptibility to telavancin, a lipoglycopeptide antibiotic, by measuring zone diameters on agar plates according to standardized microbiological methods.
This single-use disc is intended for laboratory use in microbiology settings and is supplied sterile. It is classified under product code JTN as a Class II device under FDA regulations (21 CFR 866.1620). The disc is authorized for use following FDA clearance via 510(k) submission K100722, issued on March 29, 2010, and is intended exclusively for in vitro diagnostic purposes as specified in the device’s regulatory submission.
Frequently asked questions
What is the Telavancin 30 µg BBL Sensi-Disc used for in a clinical lab setting?
The Telavancin 30 µg BBL Sensi-Disc is specifically designed for in vitro antimicrobial susceptibility testing. It helps determine whether bacteria are susceptible, intermediate, or resistant to telavancin by measuring the zone of inhibition around the disc on agar plates, following standardized microbiological methods. This aids in guiding appropriate antibiotic treatment decisions.
Is the Telavancin 30 µg BBL Sensi-Disc intended for single-use or can it be reused?
The Telavancin 30 µg BBL Sensi-Disc is explicitly labeled as a single-use disc. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and accuracy of test results.
How is the Telavancin 30 µg BBL Sensi-Disc supplied, and is it sterile?
The disc is supplied sterile and is intended for laboratory use in microbiology settings. Sterility ensures reliable and accurate antimicrobial susceptibility testing results, as contamination could invalidate the test.
What regulatory pathway was followed for the FDA clearance of this device?
The Telavancin 30 µg BBL Sensi-Disc received FDA clearance through a traditional 510(k) submission (K100722), filed on March 15, 2010, and approved on March 29, 2010. It was determined to be substantially equivalent to a predicate device under product code JTN, classified as a Class II device under 21 CFR 866.1620, with review by the Microbiology (MI) Advisory Committee.
What type of bacteria is this disc intended to test for susceptibility?
While the exact bacterial strains are not specified in the data, the Telavancin 30 µg BBL Sensi-Disc is designed for in vitro agar diffusion testing to evaluate bacterial susceptibility to telavancin—a lipoglycopeptide antibiotic. It follows standardized microbiological methods to measure zone diameters on agar plates, which helps assess susceptibility across relevant bacterial pathogens in clinical microbiology.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TELAVANCIN 30 UG, BBL SENSI-DISC - fda.innolitics.com, K100722 FDA 510 (k) - TELAVANCIN 30 UG, TELAVANCIN 30 UG, BBL SENSI-DISC 510(k) K100722 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100722 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K100722 24 fields · synced Sep 18, 2026