Mueller Hinton Broth
by Anarobe Systems 510(k)
Active
510(k) K842854
Overview
Mueller Hinton Broth is a culture medium classified as Mueller Hinton Agar/Broth under the Culture Media, Antimicrobial Susceptibility Test category. It is designed for quantitative susceptibility testing of rapidly growing aerobic and facultatively anaerobic bacteria, adhering to standardized microbiological protocols for antimicrobial resistance evaluation.
This sterile, ready-to-use broth is supplied for manual susceptibility testing procedures in microbiology laboratories. It contains cation-adjusted calcium and magnesium concentrations to meet Clinical and Laboratory Standards Institute (CLSI) recommendations, ensuring accurate antimicrobial susceptibility results. The product is intended for single-use applications and requires refrigerated storage as specified by the manufacturer. Authorized under FDA 510K clearance (K842854), it complies with regulatory standards for microbiological testing media.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842854 | Date17 Aug 1984 | 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- Withdrawn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
- JTZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1700
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Anarobe Systems
Questions
What is Mueller Hinton Broth used for?
Mueller Hinton Broth is specifically designed for quantitative susceptibility testing of rapidly growing aerobic and facultatively anaerobic bacteria. It helps microbiology laboratories evaluate antimicrobial resistance by providing a standardized culture medium that adheres to Clinical and Laboratory Standards Institute (CLSI) protocols. This ensures reliable and reproducible results for determining bacterial sensitivity to antibiotics.
How is Mueller Hinton Broth supplied and prepared for use?
The broth is supplied as a sterile, ready-to-use liquid medium, eliminating the need for additional preparation steps beyond opening the container. It is intended for single-use applications, meaning each vial or bottle should be used once and then discarded. This design ensures consistency and reduces the risk of contamination between tests.
Is Mueller Hinton Broth sterile and how should it be stored?
Yes, Mueller Hinton Broth is sterile upon packaging. To maintain sterility and product integrity, it must be stored refrigerated as specified by the manufacturer. Proper refrigeration prevents degradation and ensures the medium remains effective for its intended use in antimicrobial susceptibility testing.
Can Mueller Hinton Broth be reused after opening?
No, Mueller Hinton Broth is intended for single-use only. Reusing the broth after opening violates sterility protocols and could compromise the accuracy of antimicrobial susceptibility test results. Each vial or bottle should be used once and then discarded to maintain reliability and compliance with microbiological standards.
Does Mueller Hinton Broth require any special handling or regulatory compliance?
Mueller Hinton Broth is authorized under FDA 510K clearance (K842854) and is classified under the Culture Media, Antimicrobial Susceptibility Test category. It is designed to meet CLSI recommendations for cation-adjusted calcium and magnesium concentrations, ensuring compliance with regulatory standards for microbiological testing media. Laboratories using this product should follow established protocols to maintain accuracy and traceability in antimicrobial resistance testing.