Mueller-Hinton Agar
by American Laboratory Supply, Inc. 510(k)
Active
510(k) K791624
Overview
Mueller-Hinton Agar is a culture medium classified as an antimicrobial susceptibility test medium, specifically designed for bacterial growth and antibiotic susceptibility testing. It is standardized by the Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for evaluating bacterial responses to antimicrobial agents.
This dehydrated medium is supplied for laboratory use and requires preparation by reconstitution with sterile water. It is intended for single-use in microbiological testing environments, adhering to strict sterility and quality control protocols. The medium is regulated under FDA 510(k) clearance (K791624) and falls under device class II (JTZ product code) for antimicrobial susceptibility testing in microbiology settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791624 | Date24 Sep 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 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 American Laboratory Supply, Inc.
Questions
What is Mueller-Hinton Agar specifically used for in a clinical or laboratory setting?
Mueller-Hinton Agar is designed for bacterial growth and antibiotic susceptibility testing, meaning it helps determine how different bacteria respond to various antimicrobial agents. This standardized medium is widely used in microbiology labs to evaluate which antibiotics are effective against specific bacterial infections, ensuring accurate treatment guidance.
How is Mueller-Hinton Agar supplied and prepared for use?
It is supplied as a dehydrated powder for laboratory reconstitution. Before use, it must be mixed with sterile water to create a liquid medium, following the manufacturer’s instructions to ensure proper preparation and sterility. This ensures the medium is ready for single-use in microbiological testing environments.
Is Mueller-Hinton Agar intended for single-use or can it be reused?
The product is explicitly intended for single-use in microbiological testing. Reusing it could compromise sterility and accuracy, as it is designed to maintain strict quality control standards for bacterial culture and susceptibility testing.
What regulatory pathway does Mueller-Hinton Agar follow, and what does that mean for buyers?
Mueller-Hinton Agar is cleared under the FDA’s 510(k) pathway (K791624) as a Class II medical device, categorized under antimicrobial susceptibility testing media. This means it has undergone review by the FDA’s Microbiology (MI) advisory committee and is considered substantially equivalent to a predicate device, ensuring it meets established safety and performance standards for clinical use.
How should Mueller-Hinton Agar be stored to maintain its integrity?
Since it is a dehydrated medium, it should be stored in a cool, dry place away from direct sunlight and moisture to prevent degradation. Proper storage ensures the powder retains its effectiveness when reconstituted for testing, adhering to the manufacturer’s guidelines for shelf life and handling.