ETEST Benzylpenicillin
by Ab Biodisk 510(k)
Active
510(k) K980335
Overview
The ETEST Benzylpenicillin is a manual antimicrobial susceptibility test system designed to determine bacterial susceptibility to benzylpenicillin. It falls under the category of Manual Antimicrobial Susceptibility Test Systems, providing quantitative measurement of minimum inhibitory concentrations (MICs) for clinical microbiology applications. This strip-based method allows for precise interpretation of bacterial resistance or sensitivity, aiding in targeted antibiotic therapy decisions. The device adheres to regulatory standards for microbiological testing, ensuring reliable and reproducible results.
The ETEST Benzylpenicillin is supplied as a single-use, non-sterile test system intended for use in clinical microbiology laboratories. It is classified as a Class II medical device under FDA regulations (product code JWY) and requires adherence to standard microbiological practices for handling and storage. Each test strip is designed for in-vitro use with bacterial cultures and must be stored according to manufacturer instructions to maintain efficacy. The device received FDA 510(k) clearance (K980335) in 1998, confirming its compliance with applicable regulatory requirements for antimicrobial susceptibility testing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980335 | Date15 Jun 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JWY
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ab Biodisk
Questions
What is the ETEST Benzylpenicillin used for?
The ETEST Benzylpenicillin is a strip-based system for determining bacterial susceptibility to benzylpenicillin. It provides quantitative minimum inhibitory concentration (MIC) values, helping clinicians assess whether bacteria are resistant or sensitive to the antibiotic. This aids in guiding targeted antibiotic therapy decisions in clinical microbiology settings.
Is the ETEST Benzylpenicillin strip single-use or reusable?
The ETEST Benzylpenicillin is designed as a single-use test system. Each strip is intended for one in-vitro use with bacterial cultures, ensuring accuracy and preventing cross-contamination between tests. Discard used strips according to standard microbiological waste protocols.
What are the storage requirements for the ETEST Benzylpenicillin strips?
The strips must be stored according to the manufacturer’s instructions to maintain efficacy. Since they are non-sterile, they should be kept in a clean, dry environment protected from direct light and extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise test reliability.
How is the ETEST Benzylpenicillin classified under FDA regulations?
The ETEST Benzylpenicillin is classified as a Class II medical device under FDA regulations, with the product code JWY. This classification reflects its role as a manual antimicrobial susceptibility test system, requiring adherence to standard microbiological practices for safe and effective use in clinical settings.
Can the ETEST Benzylpenicillin be used with any bacterial culture?
The ETEST Benzylpenicillin is intended for in-vitro use with bacterial cultures to determine susceptibility to benzylpenicillin. However, its applicability depends on the specific bacterial species being tested, as not all bacteria respond predictably to this antibiotic. Always follow the manufacturer’s guidelines and clinical microbiology standards for proper use and interpretation of results.