21 CFR 866.4700 — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Immunology (IM) · Part 866 Subpart E—Immunology Laboratory Equipment and Reagents · § 866.4700
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | 2 | 8 | |
| OYU | Dna-Probe Kit, Human Chromosome | 2 | 3 |
Special Controls
NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
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.
De Novo Order DEN040010
NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
*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.
eCFR
NTH — System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
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.
Ecfr Llm
OYU — Dna-Probe Kit, Human Chromosome
*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.
eCFR
