MicroScan MicroStep Plus Panel New Antimicrobial - Vancomycin
by Dade Behring, Inc. 510(k)
Active
510(k) K020822
Overview
The MicroScan MicroStep Plus Panel New Antimicrobial - Vancomycin is a Manual Antimicrobial Susceptibility Test System (product code JWY) designed for in vitro determination of bacterial susceptibility to antimicrobial agents. It provides quantitative measurement of minimum inhibitory concentrations (MICs) to evaluate how bacteria respond to vancomycin and other antimicrobials, aiding in targeted antibiotic therapy selection. This system is classified under FDA regulation 866.1640 and falls under Class II medical devices with special controls, ensuring compliance with microbiology testing standards.
This panel is intended for use in clinical microbiology laboratories to assist in identifying bacterial resistance patterns. Supplied as a single-use, ready-to-use system, it requires manual handling and interpretation by trained personnel. The device is not intended for MRI use and must be stored under controlled conditions as specified by the manufacturer. Authorized for commercial distribution in the United States following FDA 510(k) clearance (K020822) under the Traditional pathway, with a decision date of May 8, 2002.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK020822 | Date8 May 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JWY
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the MicroScan MicroStep Plus Panel New Antimicrobial - Vancomycin used for?
This panel is designed for in vitro determination of bacterial susceptibility to antimicrobial agents, specifically measuring the minimum inhibitory concentration (MIC) of vancomycin and other antimicrobials. By quantifying how bacteria respond to these agents, clinicians can select targeted antibiotic therapy, helping to address bacterial resistance patterns in clinical microbiology laboratories.
How is the MicroScan MicroStep Plus Panel New Antimicrobial - Vancomycin supplied and prepared for use?
The panel is supplied as a single-use, ready-to-use system. It requires manual handling and interpretation by trained personnel in a clinical microbiology lab. No additional preparation is needed beyond following the manufacturer’s instructions for use.
Is the MicroScan MicroStep Plus Panel New Antimicrobial - Vancomycin sterile?
Yes, the panel is supplied in a sterile, single-use format. Sterility is maintained until the package is opened, ensuring reliable and safe antimicrobial susceptibility testing.
Can this panel be reused after a single test?
No, the MicroScan MicroStep Plus Panel New Antimicrobial - Vancomycin is intended for single-use only. Reusing the panel could compromise test accuracy and introduce contamination risks, which is why it is designed as a disposable system.
What storage conditions are required for this panel?
The panel must be stored under controlled conditions as specified by the manufacturer. This typically includes protection from extreme temperatures, moisture, and direct light to preserve its integrity and performance until use.