Bd Phoenix Automated Microbiology Systesm - Tigecycline (0.313-4ug/Ml) Gp
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142170 FDA 510(k)
- FDA Product Code
- LON FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1645 FDA 510(k)
- Regulation Number
- 866.1645 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Phoenix Automated Microbiology System – Tigecycline (0.313–4 µg/ml) GP is an automated antimicrobial susceptibility testing system designed for microbiology laboratories. It performs rapid identification and susceptibility testing of bacterial isolates, including resistance profiling to tigecycline and other antimicrobial agents, using sealed, self-inoculating polystyrene trays with dried reagents.
This system is supplied as a reusable instrument paired with single-use, non-refrigerated disposable panels containing 136 micro-wells. It operates under FDA 510(k) clearance (K142170) and is classified as a Class II medical device (regulation number 866.1645). Panels are intended for use in clinical microbiology settings and require no refrigeration before use.
Frequently asked questions
What types of bacterial isolates can the BD Phoenix Automated Microbiology System – Tigecycline test for resistance, and how does it perform the testing?
The BD Phoenix Automated Microbiology System – Tigecycline is designed to perform rapid identification and antimicrobial susceptibility testing for bacterial isolates, including resistance profiling to tigecycline (ranging from 0.313–4 µg/ml) and other antimicrobial agents. It uses sealed, single-use disposable panels with 136 micro-wells containing dried reagents, which automatically inoculate when the system is loaded, eliminating manual preparation steps.
Are the disposable panels for this system refrigerated before use, and how should they be stored?
No, the disposable panels for the BD Phoenix Automated Microbiology System do not require refrigeration before use. They are non-refrigerated and can be stored under standard laboratory conditions until ready for use, ensuring convenience for clinical microbiology settings.
How is the BD Phoenix Automated Microbiology System – Tigecycline supplied, and is the instrument itself reusable?
The system is supplied as a reusable instrument paired with single-use disposable panels, each containing 136 micro-wells. The reusable nature of the instrument reduces waste and maintenance costs, while the single-use panels ensure consistency and sterility for each test run.
What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?
The BD Phoenix Automated Microbiology System – Tigecycline was cleared through the FDA’s 510(k) pathway (K142170) under a traditional review process, determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under regulation number 866.1645, indicating moderate regulatory oversight.
What is the primary purpose of the disposable panels in this system, and why are they designed this way?
The disposable panels serve as sealed, self-inoculating trays with dried reagents that automate the antimicrobial susceptibility testing process. They are designed this way to eliminate manual inoculation errors, ensure sterility for each test, and simplify workflow by requiring no refrigeration or special handling before use.
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: Bd Phoenix Automated Microbiology Systesm - Tigecycline (0.313-4ug/Ml) Gp, Bd Phoenix Automated Microbiology Systesm - Tigecycline (0.313-4ug/ml ..., BD Phoenix™ Automated Identification and Susceptibility, BD (company) - Wikipedia, BD Phoenix™ Panels
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142170 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K142170 24 fields · synced Oct 6, 2026