SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE

K080887 · Sysmex America, Inc. · LKM · May 2, 2008 · Hematology

Device Facts

• Record ID: K080887
• Device Name: SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
• Applicant: Sysmex America, Inc.
• Product Code: LKM · Hematology
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i 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 and Mucus.

Device Story

Device modification involves addition of Urinalysis WAM (work area management) software system to existing urinalysis device. WAM software enables data processing and LIS (Laboratory Information System) interface. Device operates in laboratory setting; managed by laboratory personnel. Software facilitates automated data management and connectivity between urinalysis instrumentation and laboratory information systems. Modification does not alter fundamental scientific technology of parent device.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm modification impact and adherence to predetermined acceptance criteria.

Technological Characteristics

Urinalysis WAM software system; provides data processing and LIS interface capabilities. Software-based modification to existing urinalysis instrumentation.

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, Yeast-like cell, and Mucus.

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.

Submission Summary (Full Text)

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## 510(k) SUMMARY of the UF-1000i with Urinalysis WAM

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: K# 080889

| 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: March 28, 2008 |
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| 2. Name of Device: | Trade or proprietary name: Sysmex® UF-1000i with Urinalysis WAM<br>Common name: Automated urine particle analyzer.<br>Classification name:<br>Urine Particle Counter (21 CFR 864.5200, Product Code LKM)<br>Related Items:<br>Sheath: UFII SHEATH (Product code: GIF)<br>Stain: UFII SEARCH -SED (Product code: GJH)<br>Diluent: UFII PACK -SED (Product code: GIF)<br>Stain: UFII SEARCH -BAC (Product code: GJH)<br>Diluent: UFII PACK -BAC (Product code: GIF)<br>QC Material: UFII CONTROL (Product code: JIW)<br>Calibrator: UFII CALIBRATOR (Product code: JJW)<br>Option:<br>Graph printer<br>Bar code Reader<br>Rack Sampler Unit (UASU-3/UASU-4)<br>PU-17<br>Urinalysis WAM software |
| 3. Predicate Method: | Sysmex® UF-1000i (K#070910-Cleared May 25, 2007) |
| 4. Device Description<br>and Methodology: | The Sysmex® UF-1000i, an automated urine particle analyzer, is a<br>dedicated system for the analysis of microscopic formed elements in<br>urine specimens. The instrument consists for three principal units: (1)<br>Main Unit which aspirates, dilutes, mixes and analyzes urine samples;<br>(2) Auto Sampler Unit supplies samples to the Main Unit automatically;<br>(3) IPU (Information Processing Unit) which processes data from the<br>Main Unit and provides the operator interface with the system. The UF-<br>1000i is equipped with a Sampler that provides continuous automated<br>sampling for up to 50 tubes.<br><br>The instrument utilizes Sysmex flow cytometry using a red<br>semiconductor laser for analyzing organized elements of urine. Particle<br>characterization and identification is based on detection of forward<br>scatter, fluorescence and adaptive cluster analysis. Using its own<br>reagents, the UF-1000i automatically classifies organized elements of<br>urine and carries out all processes automatically from aspiration of the<br>sample to outputting the results.<br><br>Analysis results and graphics are displayed on the IPU screen. They |
| | can be printed on any of the available printers or transmitted to a Host<br>computer. |
| 5. Description of<br>Modification: | The modification that was made is the addition of the Urinalysis WAM<br>software on the IPU of the UF-1000i. This software is a modular work<br>area management (WAM) system for data processing and acts as an<br>independent data manager system that interfaces with the UF-1000i and<br>the LIS (Laboratory Information System). This data manager has the<br>capability for patient demographics, test orders and test results. It<br>provides a library of rules for reflex orders for repeats or additional<br>testing. |
| 6. Intended Use: | The Sysmex® UF-1000i is an automated urine particle analyzer for in<br>vitro diagnostic use in screening patient populations found in clinical<br>laboratories. The UF-1000i analyzes the following parameters in urine<br>samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the<br>presence of the following: Pathologic Cast, Crystal, Sperm, Small<br>Round Cell, Yeast like cell and Mucus. |
| 7. Substantial<br>equivalence-<br>Similarities and<br>Differences: | Design validation studies were completed and sample integrity study<br>was performed. and there is no difference between the UF-1000i and<br>the UF-1000i with Urinalysis WAM software. |
| 8. Conclusion | The UF-1000i with Urinalysis WAM software demonstrates substantial<br>equivalence to the UF-1000i without the Urinalysis WAM software. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

**MAY - 2 2008**

Sysmex America, Inc. C/O Nina Gamperling One Nelson C. White Parkway Mundelein, Illinois 60060

Re: k080887

Trade/Device Name: Sysmex® UF-1000i, Automated Urine Particle Analyzer with Urinalysis WAM Regulation Number: 21 CFR 864.5200 Regulation Name: Automated Urine Particle Analyzer Regulatory Class: Class II Product Code: LKM Dated: March 28, 2008 Received: April 1, 2008

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Robert Becker

Robert L. Becker, Jr., M.D., Ph.D. 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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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- Division ------D.O. D.O.

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## Indications for Use

510(k) Number (if known): K080887

Device Name: Sysmex® UF-100i,Automated Urine Particle Analyzer with Urinalysis WAM

Indications for Use:

Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i 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 and Mucus.

Steerline Buntader

Division Sign-Off

**Office of In Vitro Diagnostic Device**
Evaluation and Safety

510(k) K080887

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)