# K042812: Bblchromagar Mrsa

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 22, 2004 after 41 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: 1 generation back to K863821 (1986). 1 ancestor in all.
12 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K070361: Mrsaselect (2007), 4 descendants of its own
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), 3 descendants of its own
- K081212: Mrsaselect - Extended Incubation (2008), 3 descendants of its own
- K100589: Mrsa Select - Skin and Soft Tissue Wound Specimens (2010), 2 descendants of its own
- K101879: Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 (2010), 2 descendants of its own

## Indications for use
BBLTI CHROMagar TM MRSA is a selective and differential 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 and healthcare workers to screen for MRSA colonization. BBLTM CHROMagar TM MRSA is not intended to diagnose MRSA infection nor to guide or monitor treatment for infections.

Source page: https://510kreport.com/device/K042812
Methodology: https://510kreport.com/methodology