# K120563: Keypath Mrsa/Mssa Blood Culture Test-BT

- Pathway: 510(k) (Traditional)
- Applicant: Microphage, Inc.
- Decided: Mar 30, 2012 after 35 days
- Product code: OUS (Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood  Culture Test Bt)
- Device class: 1
- Regulation: 21 CFR 866.2050
- 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 K020322 (2002). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102342: Keypath (TM) Mrsa/Mssa Blood Culture Test- BT, Microphage, Inc. (2011) Summary page 1.

## Indications for use
The KeyPath TM MRSA/MSSA Blood Culture Test - BT is a qualitative in vitro diagnostic test for the timely identification of Staphylococcus aureus (S. aureus) and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures. The Test uses bacteriophage amplification to identify the presence of S. aureus and assess the phenotypic response of the target organism to cefoxitin, an indicator of oxacillin (a methicillin analog) resistance. The assay is performed directly on positive blood culture specimens that are determined as Gram Positive Cocci in singles (GPC) or as Gram Positive Cocci in Clusters (GPCC) by Gram stain. The KeyPath TM MRSA/MSSA Blood Culture Test - BT is performed directly on positive blood culture specimens from BD BACTEC blood culture bottles (Plus Aerobic/F, Plus Anaerobic/F, Standard/10 Aerobic/F and Standard Anaerobic/F). The Test is indicated for use in conjunction with other laboratory and clinical data available to the physician as an aid in the detection of MRSA/MSSA from positive blood cultures. Subculturing of positive blood cultures is necessary for additional susceptibility test determinations, differentiation of mixed growth and for epidemiological typing

Source page: https://510kreport.com/device/K120563
Methodology: https://510kreport.com/methodology