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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, yeast
Regulation Description Microorganism differentiation and identification device.
Definition Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Physical State Kit contains 3 ml bottle fixation solution, 1.5 ml bottle fluorescein labeled PNA probe in hybridization solution, 50 ml concentrated wash solution. One well, Teflon coated microscope slides available from manufacturer.
Technical Method PNA probe is added to a fixed smear prepared from liquid blood culture media with yeast. Hybridization is performed during a 90 minute incubation at 55 degrees C in an incubator or slide warmer. The slide is examined by fluorescent microscopy within 2 hrs. C. albicans is identified as bright green fluorescent yeast cells, whereas non C.albicans will not fluoresce.
Target Area systemic blood cultures
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNZS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 866.2660
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    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.
Third Party Review Not Third Party Eligible
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