← Back to catalogue

MRSASelect II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171061

by Bio-Rad

Identifiers

510(k) Number
K171061 FDA 510(k)
FDA Product Code
JSO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1700 FDA 510(k)
Regulation Number
866.1700 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MRSASelect II Medium is a selective and differential chromogenic culture medium designed for the qualitative detection of methicillin-resistant Staphylococcus aureus (MRSA). It employs chromogenic substrates to visually identify MRSA colonies within 18–28 hours, enhancing sensitivity and specificity compared to traditional methods. This medium is classified as an antimicrobial susceptibility test culture medium under FDA’s device classification (JSO, Class II).

Supplied as 20 plates (90 mm diameter), the medium is intended for laboratory use in microbiology settings. It is not sterile upon receipt and requires preparation as directed by the manufacturer. The device is regulated under FDA’s 510(k) clearance (K171061) and falls under the regulatory framework for culture media (21 CFR 866.1700). No MRI safety or single-use/reusable designation is specified in the data.

Frequently asked questions

What is the MRSASelect II Medium used for in a clinical lab setting?

The MRSASelect II Medium is designed specifically for the qualitative detection of methicillin-resistant *Staphylococcus aureus* (MRSA) in microbiology labs. It uses chromogenic substrates to visually distinguish MRSA colonies from other bacteria within 18–28 hours, improving accuracy compared to traditional culture methods. This makes it ideal for identifying MRSA infections in clinical samples.

How is the MRSASelect II Medium supplied, and does it require any preparation before use?

The MRSASelect II Medium is supplied as 20 non-sterile plates (90 mm diameter) per package. Since it is not sterile upon receipt, it must be prepared according to the manufacturer’s instructions before use in the lab. This ensures proper functionality and reliability for MRSA detection.

Is the MRSASelect II Medium intended for single-use or can it be reused?

The provided data does not explicitly state whether the MRSASelect II Medium is designed for single-use or reuse. However, given that it is a culture medium intended for microbiological testing, it is typically used once per sample to avoid contamination risks. Always follow the manufacturer’s guidelines for proper usage.

What regulatory pathway does the MRSASelect II Medium follow, and how is it classified?

The MRSASelect II Medium is classified under FDA’s device classification as a culture medium for antimicrobial susceptibility testing (product code JSO, Class II). It received 510(k) clearance (K171061) under the traditional review pathway, determined to be *substantially equivalent* to a predicate device. This classification applies to its use in microbiology labs for MRSA detection.

Are there any special storage requirements for the MRSASelect II Medium before opening?

The data does not specify storage conditions explicitly, but non-sterile culture media like this typically require protection from moisture, extreme temperatures, and contamination. It should be stored in a cool, dry place (e.g., 2–8°C if refrigerated) until use, following the manufacturer’s instructions to maintain integrity until preparation.

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: MRSASelect II Medium | Bio-Rad, MRSASelect II Medium #63758 | Bio-Rad, MRSASelect II (K171061) — FDA 510(k) | Innolitics, Multicenter Evaluation of MRSASelect II Chromogenic Agar for ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K171061 24 fields · synced Sep 20, 2026