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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, enterococcus faecalis
Definition E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.
Physical State A mixture of fluoroscein-labeled E. faecalis specific PNA probe and a rhodamine-labeled PNA probe specific for Enterococcus species is added to a fixed smear prepared from a positive blood culture showing gram positive cocci. Hybridization is followed by a wash step. The smear is mounted and examined by fluorescent microscopy.
Technical Method E. faecalis PNA FISH is a multicolor fluorescence in situ hybridization method using protein nucleic acid probes hybridizing to E. faecalis-specific ribosomal RNA sequences and to ribosomal sequences of other Enterococcus species.
Target Area Smears made from positive blood cultures showing gram positive cocci.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOAH
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(K) Exempt
Regulation Number 866.3740
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