Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart E — Immunology Laboratory Equipment and Reagents](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents) → [21 CFR 866.4700](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4700) → OYU — Dna-Probe Kit, Human Chromosome

# OYU · Dna-Probe Kit, Human Chromosome

_Immunology · 21 CFR 866.4700 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/OYU

## Overview

- **Product Code:** OYU
- **Device Name:** Dna-Probe Kit, Human Chromosome
- **Regulation:** [21 CFR 866.4700](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4700)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K010288](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/OYU/K010288.md) | ANEUVYSION MULITICOLOR DNA PROBE KIT | Vysis | Apr 13, 2001 | SESE |
| [K972200](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/OYU/K972200.md) | ANEUVYSION | Vysis | Oct 20, 1997 | SESE |
| [K953591](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/OYU/K953591.md) | CEP 8 SPECTRUMORANGE DNA PROBE KIT | Vysis | Nov 29, 1996 | SESE |

## Top Applicants

- Vysis — 3 clearances

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/OYU](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/OYU)

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