# K171061: MRSASelect II

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 28, 2017 after 262 days
- Product code: JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)
- Device class: 2
- Regulation: 21 CFR 866.1700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K863821 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081212: Mrsaselect - Extended Incubation, Bio-Rad (2008) Summary page 5.
- K100589: Mrsa Select - Skin and Soft Tissue Wound Specimens, Bio-Rad (2010) Summary page 5.

## Recalls of this device
- Jun 8, 2018 · Class II · Z-1743-2019: Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

## Indications for use
MRSASelect™II is a selective and differential chromogenic medium for: A) The qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test can be performed on anterior nares specimens from patients to screen for MRSA colonization. MRSASelect™II is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary to recover organisms for identification, antimicrobial susceptibility testing, or epidemiological typing. Results can be interpreted after 18 to 28 hours incubation. B) The qualitative detection of methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue wound specimens. The MRSASelect™II is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. Concomitant cultures and antimicrobial susceptibility testing are necessary for all skin and soft-tissue wound specimens. MRSASelect™II is not intended to guide, or monitor treatment for MRSA infection, or provide results of susceptibility to methicillin. Results can be interpreted after 18 to 28 hours incubation.

Source page: https://510kreport.com/device/K171061
Methodology: https://510kreport.com/methodology