510(k) K113371
K113371 is an FDA 510(k) premarket notification submitted by Advandx, Inc. for the device "STAPHYLOCOCCUS QUICKFISH BC". The FDA issued a decision of Substantially Equivalent on April 3, 2012. The device falls under product code NXX (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus), a Class I device regulated under 21 CFR 866.3700. Advandx, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2012
- Date Received
- November 16, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
- Device Class
- Class I
- Regulation Number
- 866.3700
- Review Panel
- MI
- Submission Type
The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).