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U.S. Department of Health and Human Services

Product Classification

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Device fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus
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).
Physical State Kit box containing 1.5 ml Fixation Solution, S. aureus-specific PNA probe in hybridization solution, Wash Solution and Mounting Medium. One-well microscope slides, fluorescent microscope equipped with a Dual Band Filter, and Control Slides are required and are available from the manufacturer.
Technical Method Fluorescent In Situ Hybridization using protein nucleic acid (PNA) probes.
Target Area Systemic blood culture
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNXX
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(K) Exempt
Regulation Number 866.3700
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible