Identifiers
- 510(k) Number
- K130775 FDA 510(k)
- FDA Product Code
- NTH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.4700 FDA 510(k)
- Regulation Number
- 866.4700 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Duet System is an automated scanning microscope and image analysis system for fluorescence in situ hybridization (FISH) assays. It is used for in-vitro diagnostic purposes, aiding pathologists in reviewing and interpreting digital images of slides by detecting, classifying, and counting cells of interest based on color, intensity, size, pattern, and shape.
The Duet System is supplied with FDA 510(k) authorization and is classified as a class 2 device. It is intended for use in immunology laboratory settings, with a product code of NTH and regulation number 866.4700. The system is used for FISH-based cancer diagnostics and is available with a registration number of 3003909093, 3005248192, and 9615060.
Frequently asked questions
What is the Duet System used for?
The Duet System is used for in-vitro diagnostic purposes, specifically for FISH-based cancer diagnostics, to detect, classify, and count cells of interest.
Is the Duet System supplied sterile?
The description does not mention sterility, so it should be assumed the system is not supplied sterile, but rather for use in a laboratory setting with appropriate protocols.
What type of settings is the Duet System intended for?
The Duet System is intended for use in immunology laboratory settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Company — BioView | Cell Imaging Since 2000, DUET SYSTEM (K130775) — FDA 510(k) | Innolitics, Intended Use - BioView
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130775 | Class II | Active |
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Manufacturer
- Manufacturer
- BioView Ltd.
- FDA Applicant
- Bioview , Ltd.
Sources (1)
- FDA 510(k) K130775 24 fields · synced Sep 21, 2026