Dried Gram-Negative and Gram-Positive MIC/Combo Panels
by Dade Microscan, Inc. 4 variants
510(k) K010159
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010159 | Date27 Jul 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LTT
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is an Antimicrobial Susceptibility Test Panel designed to determine the minimum inhibitory concentrations (MIC) of antimicrobial agents against Gram-negative and Gram-positive bacteria. The panels contain dehydrated antimicrobial agents that, when inoculated with bacterial isolates, facilitate automated or manual testing to assess bacterial resistance patterns, aiding in targeted antibiotic therapy selection. The panels are categorized under Test, Susceptibility, Antimicrobial and are used in clinical microbiology settings for routine and critical isolate testing.
The panels are supplied as dried reagents, requiring inoculation with bacterial cultures prior to use. They are intended for single-use in microbiology laboratories and are classified as Class II medical devices under FDA regulations. Multiple panel variants exist, covering Enterobacteriaceae, non-Enterobacteriaceae, and urine/systemic reporting applications. Storage and handling follow standard aseptic practices, and their use is governed by FDA-cleared 510(k) authorization (K010159). No MRI safety considerations apply, as these are in vitro diagnostic devices.
Other devices from Dade Microscan, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Dade Microscan Gram-Negative and Gram-Positive MIC/Combo Panels?
These panels are designed to determine the minimum inhibitory concentrations (MIC) of antimicrobial agents against Gram-negative and Gram-positive bacteria. By testing bacterial isolates with dehydrated antimicrobial agents, they help clinicians identify resistance patterns, which is critical for selecting targeted antibiotic therapies. This aids in improving treatment efficacy and reducing unnecessary antibiotic use.
How are the Dade Microscan MIC/Combo Panels supplied and prepared for use?
The panels are supplied as dried reagents, meaning they require inoculation with bacterial cultures before use. Laboratories must follow aseptic practices to prepare the panels by adding the appropriate bacterial isolates, after which they can be used for automated or manual testing. This ensures accurate susceptibility results while maintaining sterility.
Are the Dade Microscan MIC/Combo Panels intended for single-use or reusable applications?
These panels are explicitly designed for single-use only. Each panel is meant to be used once with a specific bacterial isolate, after which it should be discarded. This design minimizes contamination risks and ensures consistent, reliable results for each test.
What types of bacterial testing do the Gram-Negative and Gram-Positive MIC/Combo Panels support?
The panels cover multiple clinical applications, including testing for Enterobacteriaceae, non-Enterobacteriaceae, and urine/systemic infections. This versatility allows microbiology labs to assess resistance patterns across a broad range of Gram-negative and Gram-positive pathogens, supporting routine and critical isolate evaluations.
How should the Dade Microscan MIC/Combo Panels be stored, and what precautions should be taken?
Storage follows standard aseptic practices for dried reagents, typically in a clean, dry environment protected from moisture and extreme temperatures. Since they are single-use and require inoculation before use, labs must ensure the packaging remains intact until preparation. Proper storage prevents degradation of the antimicrobial agents and maintains the integrity of the test results.