(137 days)
The Duet™ System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic usc as an aiding tool to the pathologist in the detection, classification and counting of cells of interest based on color, intensity, size, pattern, and shape. The Duet™ System is intended to detect:
- Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from ccll suspension.
- Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
- Cells in urine specimens, stained by FISH (using the Vysis UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus), from subjects with transitional cell carcinoma of the bladder.
The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide screening by making a significant reduction in time and labor currently required. The Duet™ scans in high resolution and in full color cell samples at high speed both in bright light illumination and in fluorescent illumination. Duet™ suggests classification of the cells according to their morphological features, their staining (Giemsa, IHC) and fluorescent signals, and allows the user to quickly examine the results, correct them as needed and generate a report summarizing the sample's data. The unique feature of the Duet system allows the presents combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.
Here's a detailed breakdown of the acceptance criteria and the studies performed for the Duet™ system, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit from Study Design) | Reported Device Performance (Duet™ System) |
|---|---|
| Equivalence to manual scoring for detection and enumeration of FISH signals in urine specimens (UroVysion™ Kit) | Overall Agreement: 0.918 Kappa value (P-value |
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).