# K102342: Keypath (TM) Mrsa/Mssa Blood Culture Test- BT

- Pathway: 510(k) (Traditional)
- Applicant: Microphage, Inc.
- Decided: May 5, 2011 after 260 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: 3 generations back to K020322 (2002). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071026: BD Geneohm Staphsr Assay, Bd Diagnostics (Geneohm Sciences Canada, Inc) (2007) Summary page 2.
- K851949: Staphaurex ZL30, Wellcome Diagnostics (1985) Summary page 2.
- K011710: Oxoid PBP2 1 Latex Agglutination Test, Oxoid, Ltd. (2002)
- (no number) Coagulase Test and Catalase Test (multiple manufacturers): named in the summary without a submission number
- (no number) BD BBL 30 µg cefoxitin Sensi-Disc: named in the summary without a submission number
- (no number) BD BBL 1 µg oxacillin Sensi-Disc: named in the summary without a submission number

## Most influential descendants
- K120563: Keypath Mrsa/Mssa Blood Culture Test-BT (2012), 0 descendants of its own

## Indications for use
The KeyPath T M 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 TMMRSA/MSSA Blood Culture Test - BT is performed directly on positive blood culture specimens from BD BACTECTM blood culture bottles (Plus Aerobic/F and Plus 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/K102342
Methodology: https://510kreport.com/methodology