SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER

K053135 · Sysmex America, Inc. · LKM · Jan 4, 2006 · Hematology

Device Facts

• Record ID: K053135
• Device Name: SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
• Applicant: Sysmex America, Inc.
• Product Code: LKM · Hematology
• Decision Date: Jan 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-100i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell.

Device Story

Sysmex UF-100i is an automated urine cell analyzer used in clinical laboratories. It processes random urine samples to identify and quantify microscopic formed elements. The device utilizes laser flow cytometry (forward scatter and fluorescence) and impedance technology to analyze urine constituents. It provides quantitative results for RBC, WBC, Epithelial Cells, Cast, and Bacteria, while flagging potential presence of Pathologic Cast, Crystal, Sperm, Small Round Cell, and Yeast-like cells. The system is designed to be used in conjunction with a reagent strip reader to generate a comprehensive urinalysis profile. Healthcare providers use these outputs to screen patient urine samples, aiding in the assessment of urinary tract health and the identification of abnormalities. The device streamlines laboratory workflows by automating microscopic analysis, reducing manual labor, and providing standardized, objective results for clinical decision-making.

Clinical Evidence

Bench testing only. Performance was established via comparison to the predicate device (UF-100), demonstrating excellent correlation for all analyzed parameters.

Technological Characteristics

Automated urine cell analyzer utilizing laser flow cytometry (forward scatter and fluorescence) and impedance. Reagents: URINOSHEATH, URINOSEARCH, URINOPACK. Hardware includes front upper cover and hinge modifications; laser transformer removed. Connectivity: interfaces with reagent strip reader. In vitro diagnostic use.

Indications for Use

Indicated for in vitro diagnostic screening of urine samples in clinical laboratory settings to analyze RBC, WBC, Epithelial Cells, Cast, and Bacteria, and to flag Pathologic Cast, Crystal, Sperm, Small Round Cell, and Yeast-like cells.

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

• Sysmex UF-100

Submission Summary (Full Text)

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#### JAN 4 2006

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 053135

| 1. Submitted by: | Sysmex America, Inc.<br>One Nelson C. White Parkway<br>Mundelein, IL 60060<br>Phone: [phone]; FAX: [phone]<br>Contact person: Nina Gamperling<br>Date prepared: November 4, 2005 |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® Automated Urine Cell<br>Analyzer, UF-100i |
| | Common name: Automated Urine Cell Analyzer. |
| | Classification name: Sysmex® UF-100i, Automated Urine Cell<br>Analyzer, is a Urine Particle Counter (21 CFR 864.5200) is a<br>Class II medical device. |
| 3. Predicate Method: | The Sysmex® UF-100i claims substantial equivalence to the UF-<br>100, the predicate method. |
| 4. Device Description: | The Sysmex® UF-100i, automated urine cell analyzer is a<br>dedicated system for the analysis of microscopic formed elements<br>in urine specimens. It accomplishes this by the principles of<br>Laser Flow Cytometry and Impedance. The UF-100i attached to<br>a commercially available reagent strip reader provides all that is<br>required to perform an automated urinalysis profile consisting of<br>chemistries and microscopic results. |
| 5. Intended Use: | The Sysmex® UF-100i is an automated urine cell analyzer for in<br>vitro diagnostic use in screening patient populations found in<br>clinical laboratories. The UF-100i analyzes the following<br>parameters in urine samples: RBC, WBC, Epithelial Cells, Cast,<br>and Bacteria and flags the presence of the following: Pathologic<br>Cast, Crystal, Sperm, Small Round Cell, Yeast like cell. |
| 6. Substantial<br>equivalence-similarities<br>and differences: | The following table compares the UF-100i with the UF-100, the<br>predicate method. |

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

| Sysmex UF-100 | | Sysmex UF-100i |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate | Modification of Predicate |
| Intended Use | The SysmexTM UF-100 is intended for<br>in vitro diagnostic use in clinical<br>laboratories. The UF-100 analyzes the<br>following parameters: RBC, WBC,<br>Epithelial Cells, Cast, and Bacteria<br>and flags the presence of the<br>following: Pathologic Cast, Crystal,<br>Yeast like cell, Sperm and Small<br>Round Cell. | The Sysmex® UF-100i is an<br>automated urine cell analyzer for<br>in vitro diagnostic use in screening<br>patient populations found in<br>clinical laboratories. The UF-100i<br>analyzes the following parameters<br>in urine samples: RBC, WBC,<br>Epithelial Cells, Cast, and Bacteria<br>and flags the presence of the<br>following: Pathologic Cast, Crystal,<br>Sperm, Small Round Cell, Yeast like<br>cell. |
| Methodology | The UF-100 uses the technique of<br>flow cytometry measuring forward<br>scatter and fluorescence and<br>impedance. | The UF-100i uses the same<br>methodology as the UF-100. |
| Reagents | URINOSHEATH<br>URINOSEARCH<br>URINOPACK | The UF-100i uses the same reagents<br>as the UF-100. |
| Software/<br>Hardware<br>Differences | --- | New front upper cover and hinge, no<br>laser transformer, screen and labeling<br>changes. |
| Specimen Type | Random urine sample | Same as UF-100 |
| Accuracy | Performance was established in the<br>previous 510(k) submission. | Comparison to the UF-100<br>demonstrated excellent correlation. |

# Comparison Table to Predicate Method

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

JAN 4 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nina M. Gamperling Manager, Regulatory Affairs Sysmex American, Inc. One Nelson C. White Parkway Mundelein, IL 60060

Re: k053135

Trade/Device Name: Sysmex® UF-100i, Automated Urine Cell Analyzer Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: November 04, 2005 Received: November 08, 2005

Dear Ms. Gamperling:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

K053135 510(k) Number (if known):

Device Name: Sysmex® UF-100i, Automated Urine Cell Analyzer

### Indications For Use:

The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-100i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CHRD, Office of Device Evaluation (ODE)

Prescription Use X

OR

Over-The-Counter Use

Robert L. Beckerf
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 11

Sysmex UF-100i, Automated Urine Cell Analyzer
510(k) FDA Submission

510(k) <053/35