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HardyDisk Rifampin, 5MCG

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003537

by Hardy Diagnostics

Identifiers

510(k) Number
K003537 FDA 510(k)
FDA Product Code
JTN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1620 FDA 510(k)
Regulation Number
866.1620 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HardyDisk Rifampin, 5mcg is an antimicrobial susceptibility test disc used for semi-quantitative in vitro susceptibility testing of bacterial pathogens. Classified as a susceptibility test disc under the FDA’s device classification (JTN), it adheres to the Kirby-Bauer agar diffusion method to evaluate bacterial response to rifampin. This disc is designed for microbiology applications, specifically to assess resistance patterns in rapidly growing and fastidious bacteria.

Supplied in cartridges compatible with BBL single or multiple disk dispensers, each cartridge contains 50 spring-loaded discs for reliable dispensing. The device is intended for single-use in clinical microbiology laboratories and requires sterile handling. Regulated under FDA’s 510(k) clearance (K003537), it falls under Class II medical devices (regulation number 866.1620) and is distributed for use in microbiology settings. No MRI safety or reusable specifications are indicated.

Frequently asked questions

What is the HardyDisk Rifampin 5mcg disc used for?

The HardyDisk Rifampin 5mcg disc is designed for semi-quantitative in vitro susceptibility testing of bacterial pathogens. It evaluates bacterial resistance patterns to rifampin, specifically for rapidly growing and fastidious bacteria, using the Kirby-Bauer agar diffusion method. This helps microbiologists determine appropriate antibiotic treatment strategies.

How is the HardyDisk Rifampin 5mcg disc supplied and how should it be handled?

The disc is supplied in cartridges compatible with BBL single or multiple disk dispensers. Each cartridge contains 50 spring-loaded discs, ensuring reliable dispensing in clinical microbiology laboratories. Due to its single-use nature, sterile handling is required to maintain accuracy and prevent contamination.

Is the HardyDisk Rifampin 5mcg disc reusable or intended for single-use?

The HardyDisk Rifampin 5mcg disc is explicitly intended for single-use only. This design ensures consistent and reliable results, as reuse could compromise sterility and accuracy in susceptibility testing. Laboratories must adhere to single-use protocols to maintain proper microbiological practices.

What regulatory clearance does the HardyDisk Rifampin 5mcg disc hold?

The HardyDisk Rifampin 5mcg disc holds FDA 510(k) clearance under the classification of susceptibility test discs (JTN). It is classified as a Class II medical device under regulation number 866.1620, with a clearance number of K003537. This clearance confirms its substantial equivalence to a predicate device and compliance with FDA standards for antimicrobial susceptibility testing.

Can this disc be used with any microbiology testing system?

The disc is specifically designed to work with BBL single or multiple disk dispensers, which are commonly used in microbiology laboratories. While it adheres to the Kirby-Bauer agar diffusion method—a widely accepted standard—compatibility with other systems should be verified by the laboratory to ensure accurate and reliable results. Always follow manufacturer guidelines for optimal performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HardyDisks™ for Antibiotic Resistance/Antibiotic ... - Hardy Diagnostics, HARDYDISK RIFAMPIN, 5MCG (K003537) — FDA 510 (k) | Innolitics, HARDY DIAGNOSTICS FDA Filings - FDA.report, FDA 510 (k) Applications Submitted by Hardy Diagnostics, 510 (K) Premarket Notification

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hardy Diagnostics

Sources (1)

  • FDA 510(k) K003537 24 fields · synced Oct 1, 2026