510(k) K120563
K120563 is an FDA 510(k) premarket notification submitted by Microphage, Inc. for the device "KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT". The FDA issued a decision of Substantially Equivalent on March 30, 2012. The device falls under product code OUS (Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt), a Class I device regulated under 21 CFR 866.2050. Microphage, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2012
- Date Received
- February 24, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
- Device Class
- Class I
- Regulation Number
- 866.2050
- Review Panel
- MI
- Submission Type
The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.