900UDX URINE PATHOLOGY SYSTEM

K960054 · Intl. Remote Imaging Systems · KQO · Mar 22, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960054
• Device Name: 900UDX URINE PATHOLOGY SYSTEM
• Applicant: Intl. Remote Imaging Systems
• Product Code: KQO · Clinical Chemistry
• Decision Date: Mar 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.

Device Story

Automated urinalysis system; performs routine urine chemistry, specific gravity, and sediment microscopic examination. System utilizes autosampler for specimen aspiration; replaces manual pouring. Integrates chemistry results from external Boehringer Mannheim Hitachi CHEMSTRIP Super UA Urine Analyzer. Microscopic images processed and displayed on independent ViewStation computer with high resolution. Operators review, confirm, and release reports off-line. Enhances workflow efficiency; consolidates data management; improves detection sensitivity for renal epithelial cells and crystals compared to predicate.

Clinical Evidence

Bench testing compared 900UDx microscopic analysis performance against the Yellow IRIS Urinalysis Workstation. Results showed equivalent detection for RBC, WBC, squamous epithelial cells, pathologic casts, and yeast. 900UDx demonstrated greater sensitivity for renal epithelial cells, crystals, and overall abnormal urine detection. Reproducibility was equivalent to the predicate.

Technological Characteristics

Automated urinalysis system; includes autosampler for specimen handling and ViewStation computer for image processing/data management. Integrates with external chemistry analyzer. Features automated intelligent microscopy. Class I device per 21 CFR 862.2900 and 862.3600.

Indications for Use

Indicated for patients requiring routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Predicate Devices

• The Yellow IRIS Urinalysis Workstation with CHEMSTRIP Reader
• IRIS Flow Microscope

Reference Devices

• Boehringer Mannheim Hitachi CHEMSTRIP Super UA Urine Analyzer

Submission Summary (Full Text)

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K960054

International Remote Imaging Systems, Inc.

9162 Eton Avenue, Chatsworth, CA 91311

800-776-4747 818-709-1244 FAX [phone]

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# 510(k) SUMMARY

## 510(k) Submission K960054

### IRIS 900UDx™ Urine Pathology System

**General Information:**

**Date of Submission:** December 30, 1995

**Trade Name of Device:** 900UDx Urine Pathology System

**Common Name of Device:** Automated urinalysis system

**Classification Name:** Automated urinalysis system, 21 CFR 862.2900, Class I Microscope, 21 CFR 862.3600, Class I

**Submitter’s Name:** Alan E. Koontz, Ph.D.
Vice President, Marketing and Business Development
International Remote Imaging Systems, Inc.
9162 Eton Avenue, Chatsworth, CA 91311

**Intended Use:** The 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.

**Substantial Equivalence to Predicate Device:** The 900UDx Urine Pathology System is substantially equivalent under Section 510(k) of the Food, Drug, and Cosmetic Act to The Yellow IRIS® Urinalysis Workstation with CHEMSTRIP® Reader, and the IRIS Flow Microscope.

**Summary of Technological Characteristics:** The 900UDx Urine Pathology System provides automatic sample handling for automated intelligent microscopy and improved data presentation and management. Specimens are

510(k) Summary, 900UDx Urine Pathology System

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aspirated by an autosampler rather than poured manually. Microscopic examination results are displayed on an independent ViewStation computer with higher image resolution, and operators can confirm and release reports off-line for enhanced convenience. Chemistry results from the external Boehringer Mannheim Hitachi CHEMSTRIP® Super UA Urine Analyzer™ are automatically consolidated by the ViewStation for display and reporting.

**Performance Studies:**
Microscopic analysis performance of the 900UDx Urine Pathology System was compared with that of The Yellow IRIS Urinalysis Workstation.

**Conclusions Drawn From Clinical Tests:**
Detection of RBC, WBC, squamous epithelial cells, pathologic casts, and yeast was found to be equivalent to that of the predicate device. The 900UDx Urine Pathology System had greater sensitivity for detection of renal epithelial cells and crystals as well as for overall detection of abnormal urines. Reproducibility was equivalent to that of the predicate device. The 900UDx Urine Pathology System has been shown to be suitable for its intended use.

510(k) Summary, 900UDx Urine Pathology System