# K100589: Mrsa Select - Skin and Soft Tissue Wound Specimens

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Oct 29, 2010 after 241 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K863821 (1986). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 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 1.

## Most influential descendants
- K171061: MRSASelect II (2017), 0 descendants of its own
- K151688: chromID MRSA (2016), 0 descendants of its own

## Indications for use
MRSASelect is a selective and differential chromogenic medium for the qualitative detection of methicillin resistant Staphylococcus aureus (MRSA) from skin and soft-tissue wound specimens. The MRSASelect 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 susceptibility testing are necessary for all skin and soft-tissue wound specimens. MRSASelect is not intended to guide, or monitor treatment for MRSA infection, or provides results of susceptibility to methicillin. Results can be interpreted after 18 to 28 hours incubation.

Source page: https://510kreport.com/device/K100589
Methodology: https://510kreport.com/methodology