NTH · System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Immunology · 21 CFR 866.4700 · Class 2
Overview
| Product Code | NTH |
|---|---|
| Device Name | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays |
| Regulation | 21 CFR 866.4700 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.
Special Controls
The device is classified as Class II under regulation 21 CFR 866.4700 with special controls. The special control guidance document " Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems" is available at www.fda.gov/cdrh/oivd/guidance/1550.pdf.
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescence*in situ* Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130775 | DUET SYSTEM | Bioview , Ltd. | May 9, 2014 | SESE |
| K122554 | GENASIS SCANVIEW SYSTEM | Applied Spectral Imaging , Ltd. | Feb 7, 2013 | SESE |
| K110345 | SCANVIEW SYSTEM | Applied Spectral Imaging | Oct 19, 2011 | SESE |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Applied Spectral Imaging , Ltd. | Nov 23, 2010 | SESE |
| K080909 | ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 | Ikonisys, Inc. | Oct 17, 2008 | SESE |
| K043519 | ARIOL HER-2/NEU FISH | Applied Imaging Corp. | Apr 25, 2005 | SESE |
| K042542 | CYTOVISION FOR CEP XY | Applied Imaging Corp. | Jan 10, 2005 | SESE |
| DEN040010 | VYSIS AUTOVYSION SYSTEM | Vysis | Dec 13, 2004 | DENG |
Top Applicants
- Applied Imaging Corp. — 2 clearances
- Applied Spectral Imaging , Ltd. — 2 clearances
- Applied Spectral Imaging — 1 clearance
- Bioview , Ltd. — 1 clearance
- Ikonisys, Inc. — 1 clearance
