SYSMEX MODEL UF1000I

K070910 · Sysmex America, Inc. · LKM · May 25, 2007 · Hematology

Device Facts

• Record ID: K070910
• Device Name: SYSMEX MODEL UF1000I
• Applicant: Sysmex America, Inc.
• Product Code: LKM · Hematology
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• 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

The Sysmex UF-1000i is an automated urine particle analyzer used in clinical laboratories to analyze microscopic formed elements in urine. The system comprises a main unit for aspiration, dilution, mixing, and analysis; an auto-sampler for up to 50 tubes; and an Information Processing Unit (IPU) for data processing and operator interface. The device utilizes flow cytometry with a red semiconductor laser to analyze urine elements. Inputs include urine samples; the system transforms these via forward scatter, fluorescence, and side-scattered light signals (using a dedicated bacteria channel) into classified particle counts. Adaptive cluster analysis identifies and classifies elements. Results are displayed on the IPU, printed, or transmitted to a host computer. By automating the identification of RBCs, WBCs, bacteria, and other elements, the device assists clinicians in screening for urinary tract conditions, improving laboratory efficiency and diagnostic throughput.

Clinical Evidence

Bench testing only. Performance was established through comparison to the predicate UF-100. Data provided includes carryover, linearity, accuracy, and reproducibility studies, which demonstrated excellent correlation with the predicate device and met manufacturer specifications.

Technological Characteristics

Flow cytometry; red semiconductor laser; automated aspiration/dilution/mixing. Parameters: RBC, WBC, Epithelial Cells, Casts, Bacteria. Connectivity: IPU for data processing/operator interface. Software: Moderate Level of Concern. Calibration: Factory-set (UFII Calibrator). QC: UFII Control (2 levels). Throughput: 100 samples/hour.

Indications for Use

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

Predicate Devices

• Sysmex® UF-100 (K961054)

Submission Summary (Full Text)

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## 5. 510(k) SUMMARY of the UF-1000i

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:

| 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 30, 2007 |
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| 2. Name of Device: | Trade or proprietary name: Sysmex® UF-1000i<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 |
| 3. Predicate Method: | Sysmex® UF-100 (K961054-Cleared October 28, 1996) |
| 4. Device Description: | 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<br>can be printed on any of the available printers or transmitted to a Host |
| | computer. |
| 5. 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. |
| 6. Substantial<br>equivalence-<br>Similarities and<br>Differences: | Table 1 shows substantial equivalence of the UF-1000i to the UF-100. |
| 7. Conclusion | The UF-1000i demonstrates substantial equivalence to the predicate<br>device. |

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| Table 1: Substantial Equivalence—Similarities and Difference to UF-100 | | | |
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| | Sysmex UF-100<br>Predicate | Sysmex UF-1000i<br>Modification of Predicate | Similarity/<br>Difference |
| Intended Use | The Sysmex™ UF-100 is<br>intended for <i>in vitro</i><br>diagnostic use in clinical<br>laboratories. The UF-100<br>analyzes the following<br>parameters: RBC, WBC,<br>Epithelial Cells, Cast, and<br>Bacteria and flags the<br>presence of the following:<br>Pathologic Cast, Crystal,<br>Yeast like cell, Sperm and<br>Small Round Cell. | The Sysmex® UF-1000i is an<br>automated urine particle<br>analyzer for <i>in vitro</i><br>diagnostic use in screening<br>patient populations found in<br>clinical laboratories. The UF-<br>1000i analyzes the following<br>parameters in urine samples:<br>RBC, WBC, Epithelial Cells,<br>Cast, and Bacteria and flags<br>the presence of the following:<br>Pathologic Cast, Crystal,<br>Sperm, Small Round Cell,<br>Yeast like cell and Mucus. | The intended use<br>statement is the same.<br>The UF-1000i<br>analyzes the same<br>basic parameters but<br>has the addition of a<br>mucus flag. |
| Methodology | The instrument utilizes<br>Sysmex flow cytometry<br>using an argon laser for<br>analyzing organized<br>elements of urine. In<br>combination with flow<br>cytometry the UF-100 uses<br>an impedance<br>measurement.<br>The UF-100 uses flow<br>cytometry with impedance<br>measurement using a<br>double stain with two<br>fluorescent dyes. Particle<br>characterization and<br>identification is based on<br>detection of forward scatter,<br>fluorescence and<br>impedance signals and on<br>adaptive cluster analysis. | The instrument utilizes<br>Sysmex flow cytometry using<br>a red semiconductor laser for<br>analyzing organized elements<br>of urine. Particle<br>characterization and<br>identification is based on<br>detection of forward scatter,<br>fluorescence and adaptive<br>cluster analysis.<br>The UF-1000i uses the same<br>methodology as the UF-100<br>with the addition of a new<br>bacteria channel and side<br>scattered light signal. | Both systems use the<br>same methodology<br>but the UF-1000i has<br>an additional bacteria<br>channel and side<br>scattered light signal. |
| Reagents | URINOSHEATH<br>URINOSEARCH<br>URINOPACK | UFII SHEATH<br>UFII SEARCH -SED<br>UFII PACK -SED<br>UFII SEARCH -BAC<br>UFII PACK -BAC | The UF-100 reagents<br>have been modified<br>for use on the UF-<br>1000i with the<br>addition of UF II<br>SEARCH -BAC and<br>UF II PACK-BAC for<br>the bacteria channel. |
| Quality<br>Control/<br>Calibrator | UF-CHECK—3 levels<br>UF-CAL | UFII CONTROL—2 levels<br>UFII CALIBRATOR | UF-1000i control<br>material has a similar<br>formulation for two |

| Table 1: Substantial Equivalence-Similarities and Difference to UF-100 | | |
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| | | | control levels instead<br>of three. Calibrator<br>material is similar. |
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| Software/<br>Hardware<br>Differences | One channel for sediment<br>only. | Two channels for bacteria and<br>sediment. | The UF-1000i has a<br>separate channel for<br>the detection of<br>bacteria. |
| Specimen<br>Type | Random urine sample | Random urine sample | Both systems use the<br>same specimen type. |
| Throughput | Approx. 100 samples/hour | Same as UF-100 | Both systems have the<br>same throughput. |
| Equivalency<br>Data: | Performance was<br>established in the UF-100<br>510(k) submission<br>(K961054). | Comparison to the UF-100<br>demonstrated excellent<br>correlation. | Data consisting of<br>carryover, linearity,<br>accuracy and<br>reproducibility show<br>performance to the<br>manufacturer's<br>specifications. This<br>analysis supports the<br>claim that the UF-<br>1000i is substantially<br>equivalent to the UF-<br>100. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 5 2007

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

Re: k070910

Trade/Device Name: Sysmex ® UF-1000i Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: March 30, 2007 Received: April 2, 2007

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

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Page 2 - Nina M. Gamperling

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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/dsma/dsmamain.html.

Sincerely yours,

Robe Rete

Robert L. Becker, Jr., MD, PhD 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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## 4. INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K070910 |
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Device Name: Sysmex® UF-1000i, Automated Urine Particle Analyzer

## 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 servering 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.

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Concurrence of CHRD, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
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OR

| Over-The-Counter Use | |
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Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K070910 |
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Sysmex UF-1000i, Automated Urine Particle Analyzer 510(k) FDA Submission