Sysmex UF-5000 Fully Automated Urine Particle Analyzer

K171883 · Sysmex America, Inc. · LKM · Apr 23, 2018 · Hematology

Device Facts

• Record ID: K171883
• Device Name: Sysmex UF-5000 Fully Automated Urine Particle Analyzer
• Applicant: Sysmex America, Inc.
• Product Code: LKM · Hematology
• Decision Date: Apr 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.

Device Story

Sysmex UF-5000 is a fully automated urine particle analyzer for clinical laboratories; utilizes flow cytometry with 488 nm blue semiconductor laser. Input: urine samples (manual or automated sampler). Operation: particles pass through sheath-like laminar flow; laser irradiation generates four signals: forward scatter (size/permeability), side scatter (thickness/structure), fluorescence (stainability), and depolarized side scatter (birefringence). Algorithm: adaptive cluster analysis classifies particles into quantitative parameters (RBC, WBC, EC, Cast, Bacteria) and flags (Pathologic Cast, Crystal, Sperm, Yeast-like cell, Mucus). Output: quantitative counts and flags displayed on operator interface; alerts operator to need for further review or testing. Benefits: provides rapid screening of abnormal samples; reduces manual microscopy workload; improves laboratory efficiency.

Clinical Evidence

Bench testing only. Analytical validation included Limits of Blank, Detection, and Quantitation (LoB/LoD/LoQ), linearity, precision (repeatability and reproducibility), carryover, specimen stability, reference intervals, and method comparison against the predicate device. Results demonstrate performance, functionality, and reliability substantially equivalent to the predicate.

Technological Characteristics

Flow cytometry; 488 nm blue semiconductor laser; two-channel analysis (CR channel for WBC, EC, Bacteria; SF channel for RBC, Cast). Materials: reagents (UF-CELLSHEATH, UF-CELLPACK, UF-Fluorocell). Connectivity: Windows-based OS, barcode reader. Safety: IEC 60825-1 (laser), IEC 61010-1/2-081/2-101 (electrical/IVD safety), IEC 61326-2-6 (EMC).

Indications for Use

Indicated for in vitro diagnostic screening of urine samples in clinical laboratories to quantitate RBC, WBC, Epithelial cells, Cast, and Bacteria, and to flag for Pathologic Cast, Crystals, Sperm, Yeast-like cells, and Mucus. For prescription use only.

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-1000i, Automated Urine Particle Analyzer (K070910)

Submission Summary (Full Text)

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April 23, 2018

Sysmex America, Inc. Sharita Brooks Senior Manager, Regulatory Affairs 577 Aptakisic Road Lincolnshire, Illinois 60069

Re: K171883

Trade/Device Name: Sysmex UF-5000 Fully Automated Urine Particle Analyzer Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: June 23, 2017 Received: June 23, 2017

Dear Sharita Brooks:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Leonthena R. Carrington -S

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K171883

### Device Name

Sysmex® UF-5000 Fully Automated Urine Particle Analyzer

## Indications for Use (Describe)

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is provided below.

#### SUBMITTER 1.

Sysmex America Inc. (SAI) 577 Aptakisic Road Lincolnshire, IL 60069

Contact Person: Sharita Brooks Phone: [phone] Email: [e-mail] Date Prepared: June 21, 2017

#### 2. DEVICE

Name of Device: Sysmex® UF-5000 Fully Automated Urine Particle Analyzer Common Name: Automated Cell Counter Classification Regulation: 21 CFR 864.5200 Regulatory Class: II Product Code: LKM Panel: Hematology

#### PREDICATE DEVICE 3.

Predicate Device: Sysmex® UF-1000i, Automated Urine Particle Analyzer (K070910)

No reference devices were used in this submission.

#### DEVICE DESCRIPTION 4.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer that is used in the clinical laboratory to analyze formed elements in urine samples quantitatively and flag for the presence of particles/cells in the sample. It provides screening of abnormal samples, as well as automation and better efficiency in the laboratory. The analyzer reports analysis results on five enumerated parameters in urine: RBC (Red Blood Cells), WBC (White Blood Cells), EC (Epithelial Cells), CAST and BACT (Bacteria). It also reports flagging information on the following parameters in urine: Pathologic Cast; Crystal; Sperm; Yeast like cell; and Mucus. This flagging information alerts the operator for the need of further testing and/or review.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is a dedicated system for the analysis of microscopic formed elements in urine and uses a Microsoft® Windows Operating System. The analyzer consists of the following units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples and processes data from the main unit and provides the

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operator interface with the system; (2) Sampler Unit which supplies samples to the main unit automatically; and (3) Pneumatic Unit which supplies pressure and vacuum to the main unit.

The analyzer uses five reagents-UF-CELLSHEATH (sheath reagent), UF-CELLPACK CR and UF-CELLPACK SF (diluents) and UF-Fluorocell CR and UF-Fluorocell SF (both stains). The quality control material is UF-CONTROL.

#### INDICATION FOR USE 5.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer and its predicate device, the Sysmex® UF-1000i automated urine particle analyzer (K070910), have the same fundamental technology and comparable performance characteristics. The modifications consist of an analyzer with a higher throughput, smaller sample aspiration volume and a smaller minimum particle size detected. Table 1 below compares the subject Sysmex® UF-5000 analyzer with the predicate Sysmex® UF-1000i analyzer.

| Predicate Device | Proposed Device | Similarities/ Difference | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K070910 (SE on May 25, 2007) | -- | |
| Applicant | Sysmex America, Inc. | Sysmex America, Inc. | |
| Trade Name | Sysmex® UF-1000i, Automated<br>Urine Particle Analyzer | Sysmex® UF-5000, Fully<br>Automated Urine Particle<br>Analyzer | |
| Classification<br>Regulation | 21 CFR 864.5200 | 21 CFR 864.5200 | |
| Product Code | LKM | LKM | |
| Indications/<br>Intended Use | The Sysmex® UF-1000i is an<br>automated urine particle analyzer for<br><i>in vitro</i> diagnostic use in screening<br>patient populations found in clinical<br>laboratories. The UF-1000i analyzes<br>the following parameters in urine<br>samples: RBC, WBC, Epithelial<br>cells, Cast and Bacteria and flags the<br>presence of the following: Pathologic<br>Cast, Crystal, Sperm, Small Round<br>Cell, Yeast like cell and Mucus. | The Sysmex® UF-5000 Fully<br>Automated Urine Particle<br>Analyzer is an automated urine<br>particle analyzer for <i>in vitro</i><br>diagnostic use in screening<br>patient populations found in<br>clinical laboratories. The<br>Sysmex® UF- 5000 Fully<br>Automated Urine Particle<br>Analyzer analyzes the following<br>parameters in urine samples:<br>RBC, WBC, Epithelial cells,<br>Cast and Bacteria and flags the<br>presence of the following: | Similarities: RBC, WBC,<br>Epithelial cells, Cast, Bacteria and<br>flags Pathologic Cast, Crystal,<br>Sperm, Yeast like cells and Mucus.<br>Differences: The Sysmex® UF-<br>5000 does not have a flag for Small<br>Round Cell. |
| | Predicate Device | Proposed Device | Similarities/ Difference |
| | | Pathologic Cast, Crystal, Sperm,<br>Yeast like cells and Mucus. | |
| Parameters | Quantitative parameters: RBC,<br>WBC, Epithelial cells, Cast, Bacteria<br>in urine | Quantitative parameters: RBC,<br>WBC, Epithelial cells, Cast,<br>Bacteria in urine. | Similarities: Same quantitative<br>parameters. |
| | Flags: Pathologic Cast, Crystal,<br>Sperm, Small Round Cell, Yeast like<br>cell, Mucus | Flags: Pathologic Cast, Crystal,<br>Sperm, Yeast like cell and<br>Mucus. | Differences: The Sysmex® UF-<br>5000 does not have a flag for Small<br>Round Cell. |
| Test<br>Methodology | The instrument utilizes Sysmex®<br>flow cytometry using a red<br>semiconductor laser (wavelength<br>635nm) for analyzing organized<br>elements of urine. Particle<br>characterization and identification is<br>based on detection of forward<br>scatter, fluorescence and adaptive<br>cluster analysis. There is also a<br>bacteria channel and side scattered<br>light signal. | The instrument utilizes<br>Sysmex® flow cytometry using<br>a blue semiconductor laser<br>(wavelength 488nm) for<br>analyzing organized elements of<br>urine. Particle characterization<br>and identification is based on<br>detection of forward scatter,<br>fluorescence and adaptive cluster<br>analysis. There are two<br>channels- CR channel for WBC,<br>EC, Bacteria and SF channel for<br>RBC, Cast. | Similarities:<br>• Uses Flow Cytometry<br>method to quantitate RBC,<br>WBC, EC, CAST, and<br>BACT<br>• Principles of urine particle<br>analysis<br>• Hydraulic System (Sheath<br>Flow)<br>• Electrical system<br>• Analysis flow<br>• Sensor signal<br>• Particle signal waveform<br>Differences:<br>• Optical system is different:<br>Sysmex® UF-5000 uses a<br>blue semiconductor laser<br>(wavelength: 488nm).<br>• Aspiration, reagent amounts,<br>time & temperature |
| Reagents | UFII SHEATH (sheath) UFII<br>PACK -SED (diluent) UFII<br>SEARCH -SED (stain)<br>UFII PACK -BAC (diluent) UFII<br>SEARCH -BAC<br>(stain) | UF-CELLSHEATH (sheath)<br>UF-CELLPACK CR (diluent)<br>UF-Fluorocell CR (stain)<br>UF-CELLPACK SF (diluent)<br>UF-Fluorocell SF (stain) | Differences: Reagents |
| Quality Control | UFII CONTROL-2 levels- 5<br>parameters | UF-CONTROL-2 levels- 5<br>parameters | Differences: Controls |
| Measuring<br>Channels | SED channel: WBC, RBC, EC,<br>CAST<br>BAC channel: Bacteria | CR channel: WBC,<br>EC, Bacteria<br>SF channel: RBC, Cast | Differences: No dedicated channel<br>for bacteria. The non-nucleated<br>parameters are measured in the SF<br>Channel and the nucleated<br>parameters are measured in the CR<br>Channel. |
| Specimen Type | Random urine specimens | Random urine<br>specimens | Similarities: Urine |
| | Predicate Device | Proposed Device | Similarities/ Difference |
| Throughput | 100 samples / hour | 105 samples / hour | Similarities: Urine Differences:<br>Higher throughput |
| Minimum<br>particle size<br>detected | $0.633 \mu m$ | $0.488 \mu m$ | Differences: Smaller Particles<br>Detected |
| Aspiration<br>volume | 0.8 mL | 0.45 mL | Differences: Smaller sample<br>aspiration |
| Sample<br>Aspiration/<br>Fluidic<br>Pathway | Single pathway | Single pathway | Similarities: Single pathway |
| Dimensions (W x D x H mm) | 580 x 710 x 615 | 760 x 800 x 855 (single<br>sampler) | Differences: Larger analyzer |
| Weight (kg) | 75.5 | Approximately: 90 | Differences: Heavier analyzer |

Table 1: Device Comparison Table

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#### 7. PERFORMANCE DATA

Clinical and analytical validation testing were conducted on the Sysmex® UF-5000 Fully Automated Urine Particle Analyzer to show equivalent performance to the predicate Sysmex® UF-1000i analyzer. Testing included:

- Limits of Blank, Detection, and Quantitation (LoB/LoD/LoO) ●
- Linearity
- Precision (Repeatability and Reproducibility) ●
- Carryover ●
- Specimen Stability ●
- Reference Interval ●
- Method Comparison

Evaluation of the performance characteristics establishes that the performance, functionality, and reliability of the Sysmex® UF-5000 Fully Automated Urine Particle Analyzer are substantially equivalent to the predicate device. The evaluation included accuracy (method comparison), precision, linearity, carryover, stability, LoB, LoQ, and establishment of reference intervals.

#### CONCLUSIONS 8.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer and its predicate device, the Sysmex® UF-1000i automated urine particle analyzer (K070910), have nearly the same Intended Use, fundamental technology, and comparable performance characteristics. The modifications consist of an analyzer with a higher throughput, smaller sample aspiration volume and a smaller minimum particle size detected. The Sysmex® UF-5000 automated urine particle analyzer does

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not raise new questions of safety and effectiveness relative to the predicate device. Clinical and analytical validation testing were conducted on the Sysmex® UF-5000 analyzer to show equivalent performance to the Sysmex® UF-1000i analyzer. The evaluation included accuracy (method comparison), precision (repeatability and reproducibility), linearity, carryover, stability, Limits of Blank, Detection, and Quantitation (LoB/LoD/LoQ) and establishment of reference intervals.

Evaluation of the performance characteristics established that the Sysmex® UF-5000 analyzer is substantially equivalent to the Sysmex® UF-1000i analyzer and is suitable for the labeled indication for use.