AUTION EYE AI-4510 Urine Particle Analysis System

K232416 · Arkray, Inc. · LKM · May 3, 2024 · Hematology

Device Facts

• Record ID: K232416
• Device Name: AUTION EYE AI-4510 Urine Particle Analysis System
• Applicant: Arkray, Inc.
• Product Code: LKM · Hematology
• Decision Date: May 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples. A trained operator can set criteria for flagging specimens. All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist. The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

Device Story

Fully automated urine particle analyzer; uses flow cell digital imaging technology; clinical laboratory setting. Input: urine samples. Operation: urine passes through flow cell; illuminated by strobe lamp; three CMOS cameras capture images at different focal points. Processing: locked sorting algorithm clusters and classifies formed elements. Output: quantitative, semi-quantitative, or qualitative counts of particles; images displayed on screen. Workflow: automated classification; trained technologist reviews and reclassifies images as necessary. Benefits: standardized particle analysis; reduced manual microscopy workload; improved laboratory efficiency.

Clinical Evidence

Bench and clinical method comparison studies conducted at three CLIA-moderate complexity labs. Precision (repeatability, within-lab, reproducibility) evaluated per CLSI EP05-A3. Linearity (CLSI EP06-A2) and LoD/LoQ (CLSI EP17-A2) established. Method comparison (n=1474) against iQ200 and manual microscopy showed acceptable agreement; PPA/NPA for qualitative elements ranged from 80.2% to 99.6%. Interference and carryover testing confirmed performance within predefined acceptance criteria.

Technological Characteristics

Flow cell digital imaging; CMOS image sensors; strobe lamp illumination. Dimensions: 530x600x650 mm. Connectivity: standalone or integrated with AUTION MAX AX-4060. Software: locked sorting algorithm for clustering/classification. Power: 100-240 V AC. Indoor use only.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for the automated analysis of urine particles. Intended for quantitative measurement of RBC, WBC, and SQEC; semi-quantitative measurement of bacteria and crystals; and qualitative measurement of WBCC, NSE, hyaline casts, non-hyaline casts, yeast, mucus, and sperm in urine samples.

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

• iQ200 Urine Analyzer (K093861)

Submission Summary (Full Text)

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May 3, 2024

Arkray Inc. % Daya Ranamukhaarachi VP/Science and Regulatory Affairs ARKRAY, Inc. 5198 West 76th Street Minneapolis, Minnesota 55439

Re: K232416

Trade/Device Name: AUTION EYE AI-4510 Urine Particle Analysis System Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: April 5, 2024 Received: April 5, 2024

Dear Daya Ranamukhaarachi:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Min Wu-S

Min Wu Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K232416

Device Name

AUTION EYE AI-4510 Urine Particle Analysis System

#### Indications for Use (Describe)

AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.

A trained operator can set criteria for flagging speciment analyte image decisions should be reviewed and reclassified as necessary by a trained technologist.

The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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#### 510(k) Summary

This 510(k) Summary of the AUTION EYE AI-4510 Urine Particle Analysis System is submitted in compliance with 21 CFR807.92 for the purposes of safety and effectiveness.

| Date Prepared: | April 03, 2024 | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Establishment: | ARKRAY Factory Inc.<br>1480 Koji, Konan-cho,<br>Koka-shi<br>Shiga Japan, 520-3306 | |
| Submitter: | ARKRAY Inc.<br>Yousuien-nai, 59 Gansuin-cho,<br>Kamigyo-ku<br>Kyoto Japan, 602-0008 | |
| Official US Agent: | Daya Ranamukhaarachchi, PhD<br>ARKRAY Factory USA Inc.<br>Title: VP/Science and Regulatory Affairs<br>Phone [phone]<br>Email: [e-mail] | |
| Primary Contact: | Ryan Hanson<br>ARKRAY Factory USA Inc.<br>Title: Science Affairs Manager<br>Phone [phone]<br>Email: [e-mail] | |
| Secondary Contact: | Marissa Brooks<br>ARKRAY Factory USA Inc.<br>Title: Regulatory Affairs Project Manager<br>Phone [phone]<br>Email: [e-mail] | |

# Device Name:

Trade Name: AUTION EYE AI-4510 Urine Particle Analysis System

Common Name: Automated cell counter (Urine particle counter)

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## Predicate Device:

| Trade Name: | iQ200 Urine Analyzer (K093861) |
|--------------|--------------------------------|
| Common Name: | Automated Urinalysis System |

### 5.1 Regulatory Information:

Regulatory Classification for Automated cell counter (Urine particle counter) and each of the tests are listed in Table 1.

### Table 1. Regulatory Classification for the AI-4510 System

| Test<br>Description | Product Code | Device Class | Regulation | Device Panel |
|-----------------------------------|--------------|--------------|--------------------|----------------|
| Urine Particle<br>Counter | LKM | Class II | 21 CFR<br>864.5200 | 81- Hematology |
| Automated<br>Urinalysis<br>System | KQO | Class I | 21 CFR<br>862.2900 | 75- Chemistry |

## 5.2 Intended Use

AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (RBC), white blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HY AL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples.

A trained operator can set criteria for flagging specimens. All instrument analyte image decisions should be reviewed and reclassified as necessary by a trained technologist.

The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

### 5.3 Device Description

The AI-4510 System (AUTION EYE AI-4510) is a fully automated urine particle analyzer for in vitro diagnostic use that uses flow cell digital imaging technology in a clinical laboratory setting. Based on images captured in the flow method, the instrument automatically classifies the images of various formed elements. The AI-4510 System can

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quantitatively measure RBC, WBC, and SQEC; semi-quantitatively measure BACT, and CRYS; and qualitatively measure WBCC, NSE, HYAL, NHC, YST, MUCS and SPRM in urine samples. In addition, the AI-4510 System allows trained operators to manually review and reclassify all the element images collected by the system.

### 5.4 Substantial Equivalence

The following Table 2 shows the comparisons between the predicate and candidate devices and identifies the major technological and performance characteristics.

| COMPONENT/<br>CHARACTERISTIC | PROPOSED | PREDICATE |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K232416 | K093861 |
| Device | AUTION EYE AI-4510 Urine<br>Particle Analysis System | iQ200 System with Lamina<br>Cradle |
| Device Type | Automated Cell Counter | Automated Cell Counter |
| FDA Product Code | LKM, KQO | LKM, KQO |
| FDA Authorization Use | Laboratory Use | Laboratory Use |
| Intended Use and<br>Indication for Use | AUTION EYE AI-4510 Urine<br>Particle Analysis System is a<br>fully automated urine particle<br>analyzer for <i>in vitro</i> diagnostic<br>use. AUTION EYE AI-4510 is<br>intended for the quantitative<br>measurement of red blood cells<br>(RBC), white blood cells<br>(WBC) and squamous<br>epithelial cells (SQEC), the<br>semi-quantitative measurement<br>of bacteria (BACT) and crystals<br>(CRYS) and the qualitative<br>measurement of white blood<br>cell clumps (WBCC), non-<br>squamous epithelial cells<br>(NSE), hyaline casts (HYAL),<br>non-hyaline casts (NHC), yeast | The iQ®200 System is an <i>in-vitro</i> diagnostic device used to<br>automate the complete<br>urinalysis profile, including<br>urine test strip chemistry panel<br>and microscopic sediment<br>analysis. |
| (YST), mucus (MUCS) and<br>sperm (SPRM) in urine<br>samples.<br>A trained operator can set<br>criteria for flagging specimens.<br>All instrument analyte image<br>decisions should be reviewed<br>and reclassified as necessary by<br>a trained technologist.<br>The AUTION EYE AI-4510<br>analyzer can be used as a<br>standalone unit or combined<br>with an AUTION MAX AX-<br>4060 urine chemistry analyzer. | Optionally, the iQ200 analyzer<br>can be used as a stand-alone unit,<br>or the results from the iQ200<br>analyzer can be combined with<br>other urine chemistry results<br>received from an LIS. It<br>produces quantitative or<br>qualitative counts of all formed<br>sediment elements present in<br>urine, including cells, casts,<br>crystals, and organisms. A<br>competent human operator can<br>set criteria for auto-reporting and<br>flagging specimens for review.<br>All instrument analyte image<br>decisions may be reviewed and<br>overridden by a trained<br>technologist. | |
| Measurement Principle | Same as predicate | Flow digital imaging |
| Parameters | Red blood cells (RBC), White<br>blood cells (WBC), White blood<br>cell clumps (WBCC), Squamous<br>epithelial cells (SQEC), Non-<br>squamous epithelial cells (NSE),<br>Hyaline casts (HYAL), non-<br>hyaline casts (NHC ), Bacteria<br>(BACT), Crystals (CRYS), Yeast<br>(YST),<br>Mucus (MUCS) and<br>Sperm (SPRM) | Red blood cells (RBC), White<br>blood cells (WBC), White blood<br>cell clumps (WBCC), Squamous<br>epithelial cells (SQEC), Non-<br>squamous epithelial cells (NSE),<br>Hyaline casts (HYAL),<br>Unclassified casts (NHC or<br>UNCC),<br>Bacteria (BACT), Crystals<br>(CRYS), Yeast (YST), Mucous<br>(MUCS),<br>Sperm (SPRM),<br>Dysmorphic RBC and<br>Unclassified Crystals |
| Automatic Classification | Red blood cells (RBC), white<br>blood cells (WBC), white blood<br>cell clumps (WBCC),<br>squamous epithelial cells<br>(SQEC), non-squamous epithelial<br>cells (NSE), hyaline casts<br>(HYAL), non-hyaline casts<br>(NHC), bacteria (BACT), crystal<br>(CRYS), yeast (YST), mucus<br>(MUCS) and sperm (SPRM) | Red Blood Cells (RBC), White<br>Blood Cells (WBC), White<br>Blood Cell Clumps (WBCC),<br>Squamous Epithelial Cells<br>(SQEC), Non |
| | (While a dysmorphic red blood<br>cell is counted as a red blood cell,<br>the flag can be automatically<br>assigned for the dysmorphic red<br>blood cell.) | Squamous Epithelial Cells<br>(NSE), Bacteria (BACT),<br>Crystals (UNCX), Hyaline Cast<br>(HYAL), Unclassified Cast<br>(UNCC), Yeast (BYST/HYST),<br>Sperm<br>(SPRM), Mucus (MUCS) |
| Manual Classification | Red blood cells: 2 items<br>Dysmorphic red blood cells<br>(DRBC) and red blood cell<br>clumps (RBCC) | Red blood cells: 2 items<br>Dysmorphic red blood cells<br>(DRBC) and red blood cell<br>clumps (RBCC) |
| | Crystal: 10 items Calcium oxalate<br>crystal (CAOX), calcium<br>phosphate crystal (CAPH),<br>magnesium ammonium<br>phosphate crystal (TPO4),<br>leucine crystal (LEUC), uric acid<br>crystal (URIC), calcium<br>carbonate crystal (CACB),<br>cystine crystal (CYST), tyrosine<br>crystal (TYRO),<br>amorphous salts (phosphoric<br>acid, uric acid) (AMOR) and<br>unclassified crystal (UNCX) | Crystal: 10 items Calcium<br>oxalate crystal (CAOX),<br>calcium phosphate crystal<br>(CAPH), magnesium<br>ammonium phosphate crystal<br>(TPO4), leucine crystal (LEUC),<br>uric acid crystal (URIC),<br>calcium carbonate crystal<br>(CACB), cystine crystal<br>(CYST), tyrosine crystal<br>(TYRO),<br>amorphous salts (phosphoric<br>acid, uric acid) (AMOR) and<br>unclassified crystal (UNCX) |
| | Casts: 6 items<br>Granular casts (GRAN), waxy<br>casts (WAXY), RBC casts<br>(RBCT), WBC casts (WBCT),<br>epithelial casts (EPIC) and fatty<br>casts (FATC) | Casts: 6 items<br>Granular casts (GRAN), waxy<br>casts (WAXY), RBC casts<br>(RBCT), WBC casts (WBCT),<br>epithelial casts (EPIC) and fatty<br>casts (FATC) |
| | Yeast: 1 item<br>Budding yeast (BYST) | Yeast: 1 item<br>Budding yeast (BYST) |
| | Epithelial cells: 2 items Renal<br>tubular epithelial cells (REEP),<br>transitional epithelial cells<br>(TREP) | Epithelial cells: 2 items Renal<br>tubular epithelial cells (REEP),<br>transitional epithelial cells<br>(TREP) |
| | Fat: 2 items | Fat: 2 items |
| | Fat (FAT) and oval fat body<br>(OVFB) | Fat (FAT) and oval fat body<br>(OVFB) |
| | Other categories: 5 items<br>Trichomonas (TRCH), inclusion | Other categories: 5 items |
| | cells (INCC), parasite (PARA),<br>artifact (ART) and unclassified<br>(UNCL) | Trichomonas (TRCH), inclusion<br>cells (INCC), parasite (PARA),<br>artifact (ART) and unclassified<br>(UNCL) |
| Specimen Type /<br>Measurement Object | Urine | Urine |
| Reagents | AUTION EYE Sheath Solution<br>Concentrated Washing Solution 3<br>AUTION EYE Calibrator | iQ Lamina Iris Diluent Iris<br>System Cleanser<br>iQ Focus Solution |
| Quality Control Solution | AUTION EYE Control Solution<br>(It consists of High and Low<br>levels.) | iQ Positive control,<br>iQ Negative control |
| Sample Consumption<br>Volume | Maximum 1 mL | Approximately 1.3 mL |
| Required Volume | 2 mL or more | Minimum volume 3 mL |
| Measurement Time | Approximately 45 seconds/test<br>(Excluding cases in which large<br>numbers of formed elements are<br>present or in the case of control<br>measurement) | 101 seconds/test |
| Warm up time | Maximum 10 minutes (Duration<br>after the power is turned ON. The<br>warm- up time is extended if a<br>readjustment process is added<br>during startup.) | The iQ200 System should be<br>allowed to warm up for 1 or 2<br>hours if it was turned off for<br>more than 6 hours. |
| Memory Capacity | Measurement results (Normal):<br>10,000 tests | Onboard storage of up to 10,000<br>patient results |
| Number of Captured<br>Images | Three digital cameras capture<br>1,500 frames per sample | A digital camera captures 500<br>frames per sample |
| Capturing Images | Takes images with 3 different<br>focal points using 3 digital<br>cameras | Presents a specimen to a<br>microscope coupled to a 1.3-<br>megapixel CCD (charge<br>coupling device) digital camera |
| Power | 100 - 240 V AC, 50/60 Hz<br>(Including fluctuations of<br>±10%) | Microscopy module - 90-240<br>VAC 50-60 Hz<br>200 watts max |
| Intended<br>Environment | Indoor use only | Indoor use only |
| Measurement<br>Environment | Temperature: 59 to 86 °F,<br>Humidity: 20 to 80% (No<br>condensation) | Temperature: 15-30°C (59-86°F)<br>Humidity: 20% - 80% non-<br>condensing |
| Measurement<br>source | Strobe lamp | Strobe lamp |
| Dimensions | 530 (W) × 600 (D) × 650 (H) mm<br>(including the sampler)<br><br>530 (W) × 200 (D) × 135 (H) mm<br>(sampler only) | Microscopy module - 56 H x 59<br>W x 64.8 D cm (22 H x 23 W x<br>25.5 D in.) |
| Weight | Analyzer (with the sampler):<br>Approx. 57 kg Sampler: Approx.<br>4 kg | Microscopy module -<br>45.4 kg (100 lbs.) |

Table 2. Comparison Between AUTION EYE AI-4510 and iQ200 SYSTEM

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## 5.5 Test Principle and Technology

The principle of operation of the AI-4510 System is based on image capture and the digital processing of images for particle analysis and recognition from a locked sorting algorithm for clustering and classification.

The instrument uses flow digital imaging technology with a flow cell and Complementary Metal- Oxide- Semiconductor (CMOS) image sensors. As the urine passes through the flow cell, it is illuminated by a strobe lamp. Color images are recorded from three different focal points by the CMOS image sensors. The software processes the recorded images, automatically identifying and classifying the formed elements based on the sorting algorithm. The images and the classification of the formed elements are also displayed on the device screen for the operator. The results of the measurements of formed elements for each sample can be centrally controlled by the computer. Images that could not be classified automatically can be classified manually.

### 5.6 Summary of Performance Data

Clinical and bench testing were conducted to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate device.

### Precision

Precision for the AI-4510 System was evaluated to estimate repeatability, within-laboratory precision, and reproducibility for quantitative analytes: Red Blood Cell (RBC), White Blood Cell (WBC), and Squamous Epithelial Cells (SQEC), and repeatability for all semi-quantitative and qualitative elements: Bacteria (BACT), Crystals (CRYS), White blood cell clumps (WBCC), Nonsquamous epithelial cells (NSE), Hyaline casts (HYAL), non-hyaline casts (NHC), Yeast (YST), Mucus (MUCS) and Sperm (SPRM).

Precision studies were conducted in accordance with the general guidelines established in CLSI EP05-A3; (Third Edition)- Evaluation of Precision Devices; Approved Guideline

Precision studies were conducted to evaluate measurement imprecision using both controlled materials and clinical samples, with all results meeting the predefined acceptance criteria.

There were three major studies conducted to demonstrate the precision of the AI-4510 System:

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Repeatability Study- (Quantitative, Semiquantitative, and Qualitative Elements) Results were collected with one (1) instrument, at one (1) site, with one (1) operator and 10 replicates, using clinical urine samples in the evaluation of repeatability for all twelve (12) elements from low to high concentrations.

Within-Laboratory Precision Study- (Quantitative Elements) Results collected over twenty (20) days with two (2) runs per day and two (2) replicates per run using ARKAY control materials prepared using clinical samples.

Reproducibility Study-(Quantitative Elements) Results collected from three (3) sites, with one (1) analyzer per site, and testing conducted over five (5) days with two (2) runs per day and three (3) replicates per run using commercially available control materials and ARKRAY control materials prepared using clinical samples.

Results from the analysis conducted for each study is presented in Tables 3-6 below.

| Element | Test Level | Mean Value (/μL) | Repeatability | |
|---------|------------|------------------|---------------|------|
| | | | SD | %CV |
| RBC | Low | 7.5 | 1.2 | 16.2 |
| | MDL | 42.1 | 3.2 | 7.7 |
| | Mid | 468.8 | 16.6 | 3.5 |
| | High | 858.7 | 30.6 | 3.6 |
| WBC | Low | 7.8 | 1.3 | 17.2 |
| | MDL | 38.5 | 4.8 | 12.5 |
| | Mid | 425.2 | 7.8 | 1.8 |
| | High | 918.7 | 17.5 | 1.9 |
| SQEC | Low | 6.1 | 0.9 | 14.7 |
| | MDL | 39.6 | 3.7 | 9.4 |
| | Mid | 91.6 | 4.4 | 4.8 |
| | High | 161.5 | 6.9 | 4.3 |

Table 3. Repeatability Results - Quantitative Elements

Table 4. Repeatability Results - Semi-Quantitative and Qualitative Elements

| Element | n | Test Level | Avg. Conc.<br>(/μL) | % Agreement with expected<br>rank |
|---------|----|------------|---------------------|-----------------------------------|
| BACT | 10 | Level 1 | 0.0 | 100.0% |
| | 10 | Level 2 | 55.7 | 100.0% |
| | 10 | Level 3 | 78.9 | 100.0% |
| | 10 | Level 4 | 166.5 | 100.0% |
| CRYS | 10 | Level 1 | 0.0 | 100.0% |
| | 10 | Level 2 | 41.7 | 100.0% |
| | 10 | Level 3 | 118.1 | 100.0% |
| | 10 | Level 4 | 200.7 | 100.0% |
| | 10 | Level 5 | 330.1 | 100.0% |

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| Element | n | Test Level | Avg. Conc.<br>(/μL) | % Agreement with expected<br>rank |
|---------|----|---------------|---------------------|-----------------------------------|
| NSE | 10 | Negative | 0.0 | 100.0% |
| NSE | 10 | Low positive | 4.8 | 80.0% |
| NSE | 10 | High Positive | 15.5 | 100.0% |
| HYAL | 10 | Negative | 0.0 | 100.0% |
| HYAL | 10 | Low positive | 1.2 | 100.0% |
| HYAL | 10 | High Positive | 8.2 | 100.0% |
| NHC | 10 | Negative | 0.0 | 100.0% |
| NHC | 10 | Low positive | 1.2 | 100.0% |
| NHC | 10 | High Positive | 12.9 | 100.0% |
| WBCC | 10 | Negative | 0.0 | 100.0% |
| WBCC | 10 | Low positive | 3.3 | 100.0% |
| WBCC | 10 | High Positive | 15.5 | 100.0% |
| YST | 10 | Negative | 0.0 | 100.0% |
| YST | 10 | Low positive | 11.4 | 70.0% |
| YST | 10 | High Positive | 49.3 | 100.0% |
| MUCS | 10 | Negative | 0.1 | 100.0% |
| MUCS | 10 | Low positive | 32.8 | 100.0% |
| MUCS | 10 | High Positive | 106.2 | 100.0% |
| SPRM | 10 | Negative | 0.0 | 100.0% |
| SPRM | 10 | Low positive | 7.4 | 100.0% |
| SPRM | 10 | High Positive | 32.2 | 100.0% |

Table 5. Within-Laboratory Precision Results

| | Mean Value | Repeatability | | Between Run | | Between Day | | Within Laboratory | |
|--------------|------------|---------------|------|-------------|------|-------------|-----|-------------------|------|
| Level | (/μL) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| RBC<br>Low | 8.1 | 2.0 | 24.7 | 0.3 | 3.7 | 0.2 | 2.3 | 2.0 | 25.1 |
| RBC<br>MDL | 43.1 | 4.2 | 9.8 | 2.9 | 6.7 | 0.0 | 0.0 | 5.1 | 11.9 |
| RBC<br>High | 515.7 | 22.8 | 4.4 | 18.4 | 3.6 | 13.2 | 2.6 | 32.2 | 6.2 |
| WBC<br>Low | 7.9 | 1.7 | 21.9 | 1.2 | 14.8 | 0.0 | 0.0 | 2.1 | 26.4 |
| WBC<br>MDL | 42.9 | 3.4 | 7.9 | 4.0 | 9.3 | 1.5 | 3.5 | 5.5 | 12.7 |
| WBC<br>High | 470.1 | 13.4 | 2.8 | 23.8 | 5.1 | 10.6 | 2.3 | 29.3 | 6.2 |
| SQEC<br>Low | 8.6 | 1.4 | 16.1 | 0.0 | 0.0 | 0.5 | 5.7 | 1.5 | 17.0 |
| SQEC<br>MDL | 39.5 | 3.1 | 7.9 | 0.7 | 1.7 | 1.1 | 2.7 | 3.4 | 8.5 |
| SQEC<br>High | 158.0 | 6.3 | 4.0 | 2.0 | 1.3 | 2.2 | 1.4 | 7.0 | 4.4 |

{14}------------------------------------------------

| Level | Mean<br>Value<br>(cells/µL) | Repeatability | | Between Run | | Between Day | | Between Site | | Reproducibility | |
|-----------|-----------------------------|---------------|------|-------------|-----|-------------|-----|--------------|-----|-----------------|------|
| | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| RBC Low | 8.4 | 2.0 | 23.4 | 0.0 | 0.0 | 0.7 | 8.0 | 0.5 | 6.2 | 2.1 | 25.5 |
| RBC Mid | 86.2 | 6.6 | 7.6 | 1.5 | 1.7 | 0.9 | 1.1 | 6.5 | 7.5 | 9.4 | 10.9 |
| RBC High | 675.7 | 53.9 | 8.0 | 0.0 | 0.0 | 13.4 | 2.0 | 64.3 | 9.5 | 85.0 | 12.6 |
| WBC Low | 5.7 | 1.4 | 24.5 | 0.5 | 8.2 | 0.3 | 4.8 | 0.2 | 3.2 | 1.5 | 26.5 |
| WBC Mid | 86.8 | 6.4 | 7.4 | 2.8 | 3.2 | 1.7 | 2.0 | 1.9 | 2.2 | 7.4 | 8.6 |
| WBC High | 645.0 | 20.9 | 3.2 | 20.4 | 3.2 | 13.8 | 2.1 | 37.6 | 5.8 | 49.6 | 7.7 |
| SQEC Low | 14.9 | 2.1 | 14.4 | 0.0 | 0.0 | 0.3 | 2.0 | 0.6 | 4.2 | 2.3 | 15.1 |
| SQEC High | 87.2 | 6.5 | 7.4 | 2.8 | 3.2 | 0.0 | 0.0 | 7.6 | 8.7 | 10.3 | 11.9 |

Table 6. All Sites Combined - Reproducibility Study Results

### Linearity

Linearity testing was performed for the AI-4510 System using one instrument to establish the linear interval for quantitative elements: RBC, WBC, and SQEC. The study was conducted following CLSI EP06-2" Edition and met the predefined acceptance criteria, establishing the linearity interval of the AI-4510 System quantitative elements as shown in Table 7 below.

| Table 7. AI-4510 System Linearity Interval | |
|--------------------------------------------|----------------|
| Quantitative Element | Linear Range |
| RBC | 5-1,000 RBC/μL |
| WBC | 5-1,000 WBC/μL |
| SQEC | 5-180 SQEC/μL |

7 AI 4510 System Linearity Interval

### Limit of Detection

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) were conducted for the AI-4510 System quantitative (RBC, WBC, SQEC) and semiquantitative (CRYS, BACT) elements following CLSI-EP17-A2 Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline -Second Edition. Based on the results of the study, as shown below in Table 8, all elements met the predefined acceptance criteria, thereby establishing the LoB, LoD, and LoQ for each element.

| Table 8. Results of Detection Limits | | | |
|--------------------------------------|-----|-----|-----|
| Element(cells/µL) | LoB | LoD | LoQ |
| RBC | 0.0 | 2.3 | 2.3 |
| WBC | 0.0 | 1.5 | 1.5 |
| SQEC | 0.2 | 1.6 | 1.6 |

| | | Table 8. Results of Detection Limits | |
|--|--|--------------------------------------|--|
|--|--|--------------------------------------|--|

{15}------------------------------------------------

| Element(cells/µL) | LoB | LoD | LoQ |
|-------------------|-----|-----|-----|
| CRYS | 0.0 | 6.4 | 6.4 |
| BACT | 0.0 | 6.0 | 6.0 |

### Carryover

Carryover testing was performed for the AI-4510 System to confirm that there are no carryover contaminations for all twelve (12) elements. This testing was conducted using pre-prepared concentrations of high-level and low-level samples which were aliquoted into 5 tubes each and measured alternatively as shown in Table 9 for each tested element. Based on the predefined acceptance criteria, no carryover effect was detected.

| Measurement sequence | Sample placement in rack |
|----------------------|-------------------------------|
| Set 1 | H1 L1 H2 L2 H3 L3 H4 L4 H5 L5 |
| Set 2 | H1 L1 H2 L2 H3 L3 H4 L4 H5 L5 |
| Set 3 | H1 L1 H2 L2 H3 L3 H4 L4 H5 L5 |
| Set 4 | H1 L1 H2 L2 H3 L3 H4 L4 H5 L5 |
| Set 5 | H1 L1 H2 L2 H3 L3 H4 L4 H5 L5 |

H: High level sample, L: Low level sample

### Interference

Interference testing was performed on the AI-4510 System to evaluate the influence of interfering substances on the measurement of twelve (12) particle elements using the AI-4510 System. A dose dependency evaluation was performed for those substances which were confirmed to have interference effects on the measurements to determine the highest concentration at which no interference effect is observed.

The results of this interference study are summarized in Tables 10-12 below.

| Element | Interferent | Concentration<br>Limit with No<br>Significant<br>Interference | Concentration of Interferent and Observed Effect |
|---------|-----------------|---------------------------------------------------------------|------------------------------------------------------------------------------|
| RBC | Trichomonas | 50 /μL | At 120 /µL falsely increased for negative samples |
| | Turbidity | 1+ ** | At 2+ falsely decreased for positive samples |
| | Bacteria | 4000 /μL…