# K092767: BBL Chromagar Mrsa II

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Aug 20, 2010 after 345 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: 2 generations back to K863821 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042812: Bblchromagar Mrsa, Becton, Dickinson & CO (2004) Summary page 1.
- K863821: Mueller Hinton Agar W/4%Nacl and Oxacillin, Gibco Laboratories Life Technologies, Inc. (1986) Summary page 1.

## Indications for use
BBL CHROMagar MRSA II is a selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test is performed on anterior nares swab specimens from patients to screen for MRSA colonization. BBL CHROMagar MRSA II is not intended to diagnose, guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary for organism identification, susceptibility testing or epidemiological typing.

Source page: https://510kreport.com/device/K092767
Methodology: https://510kreport.com/methodology