510(k) K093346
K093346 is an FDA 510(k) premarket notification submitted by Bd Diagnostics (Geneohm Sciences, Inc.) for the device "BD GENEOHM MRSA ACP ASSAY". The FDA issued a decision of Substantially Equivalent on December 15, 2009. The device falls under product code NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen), a Class II device regulated under 21 CFR 866.1640. Bd Diagnostics (Geneohm Sciences, Inc.) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2009
- Date Received
- October 26, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.