Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
The FISH (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, RNA, Staphylococcus Aureus (product code NXX) is a qualitative nucleic acid hybridization assay used for the presumptive identification of Staphylococcus aureus from blood cultures with gram-positive cocci in clusters. It is classified as FDA Class 1, regulated under 21 CFR 866.3700 within the Microbiology specialty, and is not exempt from 510(k) requirements per 21 CFR part 866.9(c)(6). The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NXX
- Device Class
- FDA class 1
- Regulation Number
- 866.3700
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
Definition
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K113371 | STAPHYLOCOCCUS QUICKFISH BC | Apr 03, 2012 | Substantially Equivalent | Advandx, Inc. |
| K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | Nov 23, 2009 | Substantially Equivalent | Advandx, Inc. |
| K091827 | S. AUREUS PNA FISH | Aug 18, 2009 | Substantially Equivalent | Advandx, Inc. |
| K060099 | S. AUREUS PNA FISH | May 08, 2006 | Substantially Equivalent | Advandx, Inc. |