THE YELLOW IRIS URINALYSIS WORKSTATION

K972141 · Intl. Remote Imaging Systems · KQO · Aug 25, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972141
• Device Name: THE YELLOW IRIS URINALYSIS WORKSTATION
• Applicant: Intl. Remote Imaging Systems
• Product Code: KQO · Clinical Chemistry
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations. It is capable of detecting and reporting all types of formed urine sediment elements and of quantitating such elements, when desired, based on observed proportion of total particulate count. The Yellow IRIS is intended to replace the conventional intensive manipulatively manual complete urinalysis procedure as well as the abbreviated.

Device Story

The Yellow IRIS urinalysis workstation automates complete urinalysis, replacing manual microscopy and chemistry procedures. It processes urine samples to perform chemistry analysis, specific gravity determination, and sediment microscopy. The system detects and quantitates formed urine sediment elements based on particulate count proportions. Operated by trained personnel in clinical laboratory settings, the device provides automated results that assist clinicians in identifying abnormal microscopic content, such as red blood cells, white blood cells, and bacteria. By providing higher sensitivity for detecting these elements compared to traditional dipstick screening algorithms, the device aids in more accurate clinical assessment of urinary abnormalities.

Clinical Evidence

Clinical study of >18,000 abnormal urine specimens across >100 clinical laboratories. Compared The Yellow IRIS flow microscopy against urine test strip chemistry and dipstick screening algorithms. Results showed increased sensitivity for detecting abnormal red blood cells (37.9%), white blood cells (80.8%), and bacteria (555.5%) compared to chemical dipstick methods. The device also identified 29.4% and 13.4% more specimens with abnormal content than three-part and six-part dipstick screening algorithms, respectively.

Technological Characteristics

Urinalysis workstation integrating chemistry analysis, specific gravity measurement, and automated flow microscopy. System performs automated detection and quantification of urine sediment elements. Operates as a laboratory-based diagnostic workstation.

Indications for Use

Indicated for use by competent human operators to perform complete urinalysis, including chemistry, sediment microscopy, and specific gravity, for the detection and quantification of urine sediment elements.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

K972141

AUG 25 :097

Supplement to K972141 June 17, 1997 (Amended on August 22, 1997)

Device Name: The Yellow IRIS urinalysis workstation

## K. 510(k) summary statement

This submission supports the position of increased sensitivity in the detection of abnormal microscopic content using The Yellow IRIS urinalysis workstation, an already existing commercial in-vitro diagnostic device, compared to what can be obtained both by individual surrogate measures carried out on unne test strips and combinations of their measures in popular screening algorithms.

It reports a study which comprises compansons of detection of microscopic abnormalities in a population of more than 18,000 abnormal unine specimens by dipstick screening and by visual observation of flow microscopy using The Yellow IRIS. The comparative measures were carried out among more than 100 clinical laboratories, in which both unine test strips and The Yellow IRIS are used to perform a complete routine unnalysis.

The Yellow IRIS shows 37.9%, 80.8%, and 555.5% greater sensitivity in the microscopic detection of abnormal numbers of red blood cells, (hematuria), white blood cells, (pyuna or leukocyturia) and bacteria (bacteriuria) in unne than does chemical detection by surrogate measures using urine test strips. The Yellow IRIS also finds 29.4% and 13.4% more specimens which contain abnormal compositions of red blood cells and/or white blood cells and/or bacteria content than does a three part and six-part dipstick screening algorithm, respectively.

372-01

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

President International Remote AUG 25 1997 Imaging System, Inc. 9162 Eton Avenue Chatsworth, California 91311 Re : K972141 Trade Name: The Yellow IRIS Urinalysis Workstation Requlatory Class: I Product Code: KQO Dated: June 3, 1997 Received: June 6, 1997

Dear Mr. Deindoerfer:

Mr. Fred H. Deindoerfer

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

{2}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Supplement to K972141 June 17, 1997

The Yellow IRIS urinalysis workstation Device Name:

- J. Indications for use
The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations.

It is capable of detecting and reporting all types of formed urine sediment elements and of quantitating such elements, when desired, based on observed proportion of total particulate count.

The Yellow IRIS is intended to replace the conventional intensive manipulatively manual complete urinalysis procedure as well as the abbreviated.

Peter E. Madin

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -