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 Description

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 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.

AI/ML Overview

The provided text describes the performance data and conclusions for the Sysmex® UF-5000 Fully Automated Urine Particle Analyzer, seeking to prove its substantial equivalence to the predicate device, the Sysmex® UF-1000i. This is a submission for a 510(k) premarket notification, which focuses on demonstrating equivalence rather than establishing novel claims.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of specific acceptance criteria (e.g., target accuracy percentages, precision ranges) that the Sysmex® UF-5000 had to meet. Instead, it describes general categories of performance testing conducted to demonstrate "equivalent performance" to the predicate device:

Performance Category	Reported Device Performance
Limits of Blank, Detection, Quantitation (LoB/LoD/LoQ)	Testing was conducted. (Specific values or comparison to predicate's LoD/LoQ are not detailed in this summary, but the implication is that they are comparable or better, consistent with the smaller minimum particle size detected.)
Linearity	Testing was conducted. (Specific ranges or linearity coefficients are not detailed.)
Precision (Repeatability & Reproducibility)	Testing was conducted. (Specific CVs or precision limits are not detailed.)
Carryover	Testing was conducted. (Specific thresholds or results are not detailed.)
Specimen Stability	Testing was conducted. (Specific stability periods or criteria are not detailed.)
Reference Interval	Establishment of reference intervals was part of the evaluation. (The specific intervals or how they were established are not detailed.)
Method Comparison (Accuracy)	Clinical and analytical validation testing were conducted to show equivalent performance to the predicate Sysmex® UF-1000i analyzer. "Accuracy (method comparison)" was included in the evaluation. (Specific correlation coefficients, bias, or agreement rates for parameters like RBC, WBC, etc., are not provided in this summary section of the 510(k). It only states that the evaluation "established that the performance, functionality, and reliability... are substantially equivalent.")

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set. It mentions "Clinical and analytical validation testing" and "Method Comparison" but provides no numbers of samples or patients.

Regarding data provenance: The document identifies Sysmex America Inc. (Illinois, USA) as the submitter. While it doesn't explicitly state the country of origin for the clinical samples, it's highly likely to be the USA, given the submitter's location and the FDA submission context. The study is implicitly prospective in nature, as it involves newly conducted validation testing for a new device to demonstrate its performance characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set. For a device like an automated cell counter, the "ground truth" for method comparison studies is typically established by comparing its results against a "gold standard" or reference method, which might be manual microscopy performed by trained laboratory professionals (medical technologists, clinical pathologists), or by comparing against the predicate device itself. However, the text does not elaborate on this.

4. Adjudication method for the test set

The document does not describe any adjudication method. Given that the device is an automated cell counter, the "ground truth" would likely be established through a reference laboratory method rather than a panel of human adjudicators in the way an imaging AI might use.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging devices where human interpretation is a primary component of the diagnostic pathway. For an automated laboratory analyzer, the performance is assessed against reference methods and statistical agreement with the predicate.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the studies described are inherently "standalone" in the context of the device's operation. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated device designed to analyze urine samples and report parameters directly. The performance evaluation (LoB/LoD/LoQ, linearity, precision, carryover, method comparison) assesses the device's analytical performance on its own, without direct real-time human intervention in the analysis process itself. Human interpretation of the results (e.g., flagging information leading to further testing) is part of its intended use, but the analytical performance is standalone.

7. The type of ground truth used

The document implies that the ground truth for the performance studies, particularly "Method Comparison," would be established by comparing the Sysmex® UF-5000's results against those of the predicate device (Sysmex® UF-1000i) and/or other established laboratory reference methods for urine particle analysis. It does not explicitly state which ultimate ground truth was used (e.g., pathology, manual microscopy, or clinical outcomes data). For quantitative parameters like RBC and WBC counts in urine, the "ground truth" often refers to the accepted values obtained from a reference measurement method.

8. The sample size for the training set

This document describes a 510(k) submission for an automated laboratory instrument, not a machine learning or AI model in the modern sense that typically involves "training sets." The "algorithm" or measurement principles (flow cytometry, laser detection, specific reagents) are embedded in the device's design. Therefore, the concept of a "training set" as it applies to AI models is not relevant here, and no information on a training set sample size is provided.

9. How the ground truth for the training set was established

As explained above, the concept of a "training set" for the Sysmex® UF-5000 as an automated instrument is not applicable in the same way it would be for AI/ML algorithms. The device's operational parameters and internal algorithms are based on established scientific principles of flow cytometry and are likely refined during product development and engineering, rather than "trained" on a dataset in the AI sense.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: 224-543-9618 Email: brookss@sysmex.com 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.

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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.

INDICATION FOR USE 5.

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, AutomatedUrine Particle Analyzer	Sysmex® UF-5000, FullyAutomated Urine ParticleAnalyzer
ClassificationRegulation	21 CFR 864.5200	21 CFR 864.5200
Product Code	LKM	LKM
Indications/Intended Use	The Sysmex® UF-1000i is anautomated urine particle analyzer forin vitro diagnostic use in screeningpatient populations found in clinicallaboratories. The UF-1000i analyzesthe following parameters in urinesamples: RBC, WBC, Epithelialcells, Cast and Bacteria and flags thepresence of the following: PathologicCast, Crystal, Sperm, Small RoundCell, Yeast like cell and Mucus.	The Sysmex® UF-5000 FullyAutomated Urine ParticleAnalyzer is an automated urineparticle analyzer for in vitrodiagnostic use in screeningpatient populations found inclinical laboratories. TheSysmex® UF- 5000 FullyAutomated Urine ParticleAnalyzer analyzes the followingparameters in urine samples:RBC, WBC, Epithelial cells,Cast and Bacteria and flags thepresence of the following:	Similarities: RBC, WBC,Epithelial cells, Cast, Bacteria andflags Pathologic Cast, Crystal,Sperm, Yeast like cells and Mucus.Differences: The Sysmex® UF-5000 does not have a flag for SmallRound Cell.
	Predicate Device	Proposed Device	Similarities/ Difference
		Pathologic Cast, Crystal, Sperm,Yeast like cells and Mucus.
Parameters	Quantitative parameters: RBC,WBC, Epithelial cells, Cast, Bacteriain urine	Quantitative parameters: RBC,WBC, Epithelial cells, Cast,Bacteria in urine.	Similarities: Same quantitativeparameters.
	Flags: Pathologic Cast, Crystal,Sperm, Small Round Cell, Yeast likecell, Mucus	Flags: Pathologic Cast, Crystal,Sperm, Yeast like cell andMucus.	Differences: The Sysmex® UF-5000 does not have a flag for SmallRound Cell.
TestMethodology	The instrument utilizes Sysmex®flow cytometry using a redsemiconductor laser (wavelength635nm) for analyzing organizedelements of urine. Particlecharacterization and identification isbased on detection of forwardscatter, fluorescence and adaptivecluster analysis. There is also abacteria channel and side scatteredlight signal.	The instrument utilizesSysmex® flow cytometry usinga blue semiconductor laser(wavelength 488nm) foranalyzing organized elements ofurine. Particle characterizationand identification is based ondetection of forward scatter,fluorescence and adaptive clusteranalysis. There are twochannels- CR channel for WBC,EC, Bacteria and SF channel forRBC, Cast.	Similarities:• Uses Flow Cytometrymethod to quantitate RBC,WBC, EC, CAST, andBACT• Principles of urine particleanalysis• Hydraulic System (SheathFlow)• Electrical system• Analysis flow• Sensor signal• Particle signal waveformDifferences:• Optical system is different:Sysmex® UF-5000 uses ablue semiconductor laser(wavelength: 488nm).• Aspiration, reagent amounts,time & temperature
Reagents	UFII SHEATH (sheath) UFIIPACK -SED (diluent) UFIISEARCH -SED (stain)UFII PACK -BAC (diluent) UFIISEARCH -BAC(stain)	UF-CELLSHEATH (sheath)UF-CELLPACK CR (diluent)UF-Fluorocell CR (stain)UF-CELLPACK SF (diluent)UF-Fluorocell SF (stain)	Differences: Reagents
Quality Control	UFII CONTROL-2 levels- 5parameters	UF-CONTROL-2 levels- 5parameters	Differences: Controls
MeasuringChannels	SED channel: WBC, RBC, EC,CASTBAC channel: Bacteria	CR channel: WBC,EC, BacteriaSF channel: RBC, Cast	Differences: No dedicated channelfor bacteria. The non-nucleatedparameters are measured in the SFChannel and the nucleatedparameters are measured in the CRChannel.
Specimen Type	Random urine specimens	Random urinespecimens	Similarities: Urine
	Predicate Device	Proposed Device	Similarities/ Difference
Throughput	100 samples / hour	105 samples / hour	Similarities: Urine Differences:Higher throughput
Minimumparticle sizedetected	$0.633 \mu m$	$0.488 \mu m$	Differences: Smaller ParticlesDetected
Aspirationvolume	0.8 mL	0.45 mL	Differences: Smaller sampleaspiration
SampleAspiration/FluidicPathway	Single pathway	Single pathway	Similarities: Single pathway
Dimensions (W x D x H mm)	580 x 710 x 615	760 x 800 x 855 (singlesampler)	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.

Regulation Number and Section

§ 864.5200 Automated cell counter.

(a)
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.(b)
Classification. Class II (performance standards).