# K081212: Mrsaselect - Extended Incubation

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 13, 2008 after 45 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: 3 generations back to K863821 (1986). 3 ancestors in all.
3 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)
- K070361: Mrsaselect, Bio-Rad (2007) Summary page 2.

## Most influential descendants
- K100589: Mrsa Select - Skin and Soft Tissue Wound Specimens (2010), 2 descendants of its own
- K171061: MRSASelect II (2017), 0 descendants of its own
- K151688: chromID MRSA (2016), 0 descendants of its own

## Recalls of this device
- Jun 8, 2018 · Class II · Z-1742-2019: Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.

## Indications for use
MRSASelect is a selective and differential chromogenic medium for 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 and healthcare workers to screen for MRSA colonization. MRSASelect is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection. Results are interpreted after 18 - 28 hours incubation.

Source page: https://510kreport.com/device/K081212
Methodology: https://510kreport.com/methodology