Microscan Synergies Plus Gram Negative Mic/Combo Panels with Ampicillin (0.25-128 Ug/Ml)
by Dade Behring, Inc. 510(k)
Active
510(k) K033482
Overview
The Microscan Synergies Plus Gram Negative MIC/Combo Panels With Ampicillin (0.25–128 µg/ml) is an automated antimicrobial susceptibility testing system designed for quantitative and qualitative assessment of antimicrobial resistance. These panels are intended for use with rapidly growing aerobic and facultative anaerobic Gram-negative bacilli, including Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. The system provides minimum inhibitory concentration (MIC) results to guide antimicrobial therapy decisions in clinical microbiology settings.
These panels are supplied as disposable, single-use reagents for use with the WalkAway® S7 System or compatible automated systems. They are not sterile and require manual preparation and inoculation by laboratory personnel. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance under the Special 510(k) pathway for microbiology applications. Storage and handling follow standard laboratory protocols for antimicrobial susceptibility testing reagents.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033482 | Date26 Nov 2003 | 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- Withdrawn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
- LON
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What is the Microscan Synergies Plus Gram-Negative MIC/Combo Panel with Ampicillin used for?
This panel is designed for quantitative and qualitative assessment of antimicrobial resistance in rapidly growing aerobic and facultative anaerobic Gram-negative bacilli. It includes Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. The results help guide antimicrobial therapy decisions in clinical microbiology settings by providing minimum inhibitory concentration (MIC) values for Ampicillin (0.25–128 µg/ml) and other antimicrobials.
How are the Microscan Synergies Plus Gram-Negative MIC/Combo Panels supplied and prepared?
The panels are supplied as disposable, single-use reagents. They are not sterile and require manual preparation and inoculation by laboratory personnel. This means each panel is intended for one-time use only and must be handled in a controlled laboratory environment following standard antimicrobial susceptibility testing protocols.
Are these panels compatible with specific automated systems?
Yes, these panels are designed for use with the WalkAway® S7 System or compatible automated systems. Compatibility ensures accurate and efficient processing of antimicrobial susceptibility testing, reducing manual intervention while maintaining reliable results.
Do these panels require special storage conditions?
The panels follow standard laboratory protocols for storage and handling, as outlined for antimicrobial susceptibility testing reagents. Proper storage conditions typically include protection from light, moisture, and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain reagent integrity and test accuracy.
What regulatory pathway was followed for this device?
The Microscan Synergies Plus Gram-Negative MIC/Combo Panels with Ampicillin received FDA 510(k) clearance under the Special 510(k) pathway for microbiology applications. This pathway is used for devices that are substantially equivalent to a predicate device already on the market, ensuring compliance with FDA regulations for Class II medical devices.