MIC-Bio-Plate
by Pasco Laboratories, Inc. 510(k)
Active
510(k) K844903
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844903 | Date24 Dec 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- JWY
- 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
The MIC-Bio-Plate is a Manual Antimicrobial Susceptibility Test System, designed for determining the minimum inhibitory concentration (MIC) of antimicrobial agents against bacterial isolates. It provides a quantitative method for evaluating bacterial resistance or susceptibility to antibiotics by measuring the lowest concentration of a drug that inhibits visible bacterial growth on agar plates.
This device is supplied as a sterile, single-use system and is intended for use in microbiology laboratories. It adheres to 21 CFR 866.1640 and has received FDA 510(k) clearance under the product code JWY, with a decision date of December 24, 1984. The plates are non-magnetic and do not contain components that would interfere with MRI environments, though their use in MRI settings is not explicitly endorsed. Storage and handling follow standard aseptic techniques for microbiological media.
Other devices from Pasco Laboratories, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the MIC-Bio-Plate used for?
The MIC-Bio-Plate is designed to determine the minimum inhibitory concentration (MIC) of antimicrobial agents against bacterial isolates. This quantitative method helps microbiology laboratories evaluate whether bacteria are resistant or susceptible to specific antibiotics by identifying the lowest drug concentration that prevents visible bacterial growth on agar plates.
How is the MIC-Bio-Plate supplied and what are its sterility and usage guidelines?
The MIC-Bio-Plate is supplied as a sterile, single-use system, ensuring contamination-free testing. It adheres to standard aseptic techniques for microbiological media, meaning it must be handled in a clean environment to maintain sterility. Single-use ensures each test is performed with a fresh, uncontaminated plate, reducing the risk of cross-contamination between samples.
Is the MIC-Bio-Plate safe for use in MRI environments?
The MIC-Bio-Plate is non-magnetic and does not contain components that would interfere with MRI environments. However, its use in MRI settings is not explicitly endorsed by the manufacturer, so caution should be exercised if proximity to MRI machines is a concern. Always follow local guidelines for handling non-MRI-safe materials in such environments.
What regulatory approval does the MIC-Bio-Plate hold?
The MIC-Bio-Plate has received FDA 510(k) clearance under product code JWY, with a decision date of December 24, 1984. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and complies with applicable regulations, including 21 CFR 866.1640 for manual antimicrobial susceptibility test systems.
Are there different sizes or models of the MIC-Bio-Plate available?
The provided data does not specify multiple sizes or models for the MIC-Bio-Plate. It is described as a singular system for determining MIC values, so it is likely offered in a standardized format. For specific variations or custom options, contact Pasco Laboratories, Inc. directly, as their product catalog may include additional details or variations not reflected in the regulatory documentation.