Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control

K142543 · ACON Laboratories, Inc. · KQO · May 11, 2015 · Clinical Chemistry

Device Facts

• Record ID: K142543
• Device Name: Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
• Applicant: ACON Laboratories, Inc.
• Product Code: KQO · Clinical Chemistry
• Decision Date: May 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The Mission® U120 Ultra Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: glucose, bilirubin, ketone (acetoacetic acid), specific gravity, pH, blood, protein, urobilinogen, leukocytes and ascorbic acid as well as the qualitative detection of nitrite. The instrument is intended for point-of-care, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. It is intended for professional use only. The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for one or more of the following analytes: ascorbic acid, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes. It is intended for professional in vitro diagnostic use only.

Device Story

Reflectance photometer analyzer; uses LED light source and CMOS image sensor to measure color intensity changes on urinalysis reagent strips; replaces manual visual color chart comparison. Used in point-of-care settings by professional operators. Features data management, internal thermal printer, and connectivity (USB, Bluetooth, RS232C, Ethernet). Provides semi-quantitative/qualitative results for 11 urine analytes. Aids clinicians in diagnosing/monitoring metabolic, kidney, and urinary tract conditions. Includes assayed liquid controls for precision validation.

Clinical Evidence

Clinical study at 3 sites with 9 intended users; 120 patient specimens per site plus contrived samples (total N=426-468 depending on analyte). Compared Mission U120 Ultra to predicate ACON U120. Results showed high agreement: exact agreement ranged from 85.5% (SG) to 100% (Nitrite); 100% agreement within one level for all analytes. Bench testing included precision, interference, temperature/voltage/humidity flex, and stability studies.

Technological Characteristics

Reflectance photometer; LED light source; CMOS image sensor. Dimensions: 26.0 x 15.0 x 17.5 cm; Weight: ≤1.66 kg. Power: 6 AA batteries or 100-240 VAC adapter. Connectivity: USB, Bluetooth, RS232C, RJ45 Ethernet. Operating conditions: 0-40°C, ≤85% RH. Touch screen LCD 640x480.

Indications for Use

Indicated for professional point-of-care in vitro diagnostic use to detect urine analytes (Glucose, Bilirubin, Ketone, Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes, Ascorbic Acid, Nitrite) for health evaluation and monitoring of metabolic, systemic, kidney, endocrine, or urinary tract diseases.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Predicate Devices

• ACON Urinalysis Reagent Strips, ACON U120 Urine Analyzer (k070929)
• Mission Liquid Urine Control, Mission Liquid Diptube Urine Control (k103387)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ACON LABORATORIES, INC. QIYI XIE SR. STAFF REGULATORY AFFAIRS & CLINICAL AFFAIRS 10125 MESA RIM ROAD SAN DIEGO CA 92121

September 17, 2015

Re: K142543

Trade/Device Name: Mission® Urinalysis Reagent Strips, Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls, Mission® U120 Ultra Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, LJX, JMA, JJW, KQO Dated: March 25, 2015 Received: March 26, 2015

Dear Qiyi Xie:

This letter corrects our substantially equivalent letter of May 11, 2015.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology 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) K142543

### Device Name

Mission® Urinalysis Reagent Strips Mission® U120 Ultra Urine Analyzer Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls

#### Indications for Use (Describe)

The Mission® U120 Ultra Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite.

The instrument is intended for point-of-care, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. It is intended for professional use only.

The Mission® Liquid Urine Controls Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.

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

| <span style="font-size:10px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:10px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|

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#### 7. 510(k) SUMMARY

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 K142543

#### Submitter's Identification:

ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121 Tel.: [phone] Fax: [phone]

Date Prepared: May 11, 2015

### Contact Person:

Qiyi Xie Senior Staff, Clinical & Regulatory Affairs Email: [e-mail]

### Proprietary Name of the Device:

Mission® Urinalysis Reagent Strips Mission® U120 Ultra Urine Analyzer Mission® Liquid Urine Controls Mission® Liquid Diptube Urine Controls

### Common Name:

Urine Chemistry Analyzer Urinalysis Controls (Assayed and Unassayed)

### Classification Name:

Class II §21 CFR § 862.1340 Urinary Glucose (Non-Quantitative) Test System

Class I §21 CFR 862.2900, Automated Urinalysis System

Class I, reserved §21 CFR 862.1660, Quality control material (assayed and unassayed)

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## Predicate Device:

ACON Urinalysis Reagent Strips, ACON U120 Urine Analyzer ACON Laboratories Inc. 10125 Mesa Rim Road San Diego, CA 92121 510(k) Number: K070929

Mission Liquid Urine Control, Mission Liquid Diptube Urine Control ACON Laboratories Inc. 10125 Mesa Rim Road San Diego, CA 92121 510(k) Number: K103387

Device Name: Mission® Urinalysis Reagent Strips, Mission® U120 Ultra Urine Analyzer Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls

| Regulation Description | Product<br>Code | Device<br>Class | Regulation |
|-------------------------------------------------------------------------|-----------------|-----------------|-------------------|
| Occult blood test | JIO | II | 21 CFR § 864.6550 |
| Urinary glucose (non-quantitative) test system | JIL | II | 21 CFR § 862.1340 |
| Urinary protein or albumin (non-quantitative)<br>test system | JIR | I | 21 CFR § 862.1645 |
| Urinary bilirubin and its conjugates (non-<br>quantitative) test system | JJB | I | 21 CFR § 862.1115 |
| Ketones (non-quantitative) test system | JIN | I | 21 CFR § 862.1435 |
| Leukocyte peroxidase test | LJX | I | 21 CFR § 864.7675 |
| Nitrite (non-quantitative) test system | JMT | I | 21 CFR § 862.1510 |
| Urinary pH (non-quantitative) test system | CEN | I | 21 CFR § 862.1550 |
| Refractometer for clinical use (specific<br>gravity) | JRE | I | 21 CFR § 862.2800 |
| Urinary urobilinogen (non-quantitative) test<br>system | CDM | I | 21 CFR § 862.1785 |
| Ascorbic acid test system | JMA | I | 21 CFR § 862.1095 |
| Quality control material (assayed and<br>unassayed) | JJW | I,<br>reserved | 21 CFR § 862.1660 |
| Automated urinalysis system | KQO | I | 21 CFR § 862.2900 |

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## Device Description:

The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Without a urine analyzer, users must visually compare the reagent areas of the strip to a color chart using the naked eye. Mission® U120 Ultra Urine Analyzer also features data management and report generation capabilities.

### Intended Use:

The Mission® U120 Ultra Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite.

The instrument is intended for point-of-care, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. It is intended for professional use only.

The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.

## Tests Principles:

The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Using a light emitting diode (LED) as the light source and a CMOS image sensor as a light sensor, the optical system reads the color change in the urine test strips after a sample is applied.

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Urine Controls: The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes.

| Feature | Mission® U120 Ultra Urine Analyzer |
|-------------------------------|------------------------------------------------------------------------------------|
| Methodology | Reflectance Photometer |
| Detection | CMOS Image Sensor |
| Chemistry | Mission® Urinalysis Reagent Strips |
| Throughput | Single Test Mode: 55 tests/hour<br>Continuous Test Mode: 120 tests/hour |
| Memory | Last 2000 results |
| Strip Incubation Time | 1 minute |
| PC Port | USB (data communications);<br>(Not connect to PC) |
| | Bluetooth Wireless |
| | Standard RS232C Port |
| | |
| Capabilities | Internal thermal printer |
| | Barcode reader Connector |
| | External printer (optional) |
| | Barcode reader (optional) |
| | RJ45 Ethernet; (optional) |
| Available Languages on Screen | English and Spanish |
| Analyzer Operating Conditions | 0-40°C (32-104°F); ≤85% Relative<br>Humidity (non-condensing) |
| | |
| Strip Operating Conditions | 15-30°C (59-86°F); 20-80% Relative<br>Humidity (non-condensing) |
| | |
| Power Source | 6 AA batteries with 100 tests/6 new<br>batteries: 100- 240 VAC(adapter). (50-60Hz) |

# Technological Characteristics:

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| | Hz± 1HZ) |
|----------------------------|--------------------------------------------------------------------|
| Weight | ≤1.66 kg (3.65 lb) without batteries or power supply |
| Dimensions (L X W X H) | 26.0 (L) x 15.0 (W) x 17.5 (H) cm<br>(10.2"x 5.9"x 6.9") |
| Display Dimensions (L X W) | Large touch screen Color LCD<br>TFT 640x480, 11.7 (W) x 8.8 (H) cm |

# Substantial Equivalence:

The Mission® U120 Urinalysis Reagent Strips and the Ultra Urine Analyzer is substantially equivalent to the ACON Urinalysis Reagent Strips and the ACON U120 Urine Analyzer (K070929):

| Item | Mission® Urinalysis Reagent Strips,<br>Mission® U120 Ultra Urine Analyzer,<br>Candidate Device | ACON Urinalysis Reagent Strips,<br>ACON U120 Urine Analyzer,<br>Predicate |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Methodology | Reflectance Photometer | Reflectance Photometer |
| Principle | The U120 Urine Analyzer<br>measures the intensity of the light<br>reflected from the reagent areas<br>of a urinalysis reagent strip. | The U120 Ultra Urine<br>Analyzer measures the<br>intensity of the light reflected<br>from the reagent areas of a<br>urinalysis reagent strip. |
| Chemistry | Mission® Urinalysis Reagent<br>Strips | Mission® Urinalysis Reagent<br>Strips |
| Analytes Detected | Leukocytes, Nitrite, blood<br>(Occult), Glucose, Protein,<br>Ketone, Specific Gravity, pH,<br>Bilirubin, Urobilinogen and<br>Ascorbic Acid | Leukocytes, Nitrite, blood<br>(Occult), Glucose, Protein,<br>Ketone, Specific Gravity, pH,<br>Bilirubin, Urobilinogen and<br>Ascorbic Acid |
| Strip Incubation<br>Time | 1 minute | 1 minute |
| Available<br>Languages on<br>Screen | English and Spanish | English and Spanish |
| Analyzer<br>Operating<br>Conditions | 0-40°C (32-104°F); ≤85%<br>Relative Humidity (non-<br>condensing) | 0-40°C (32-104°F); ≤85%<br>Relative Humidity (non-<br>condensing) |
| Line Leakage<br>Current | <0.5mA | <0.5mA |
| <b>Differences</b> | | |
| Detection | The ACON U120 Urine Analyzer<br>utilizes a photodiode to measure<br>the intensity of light. | The Mission® U120 Ultra<br>Urine Analyzer utilizes a<br>CMOS image sensor to<br>measure the intensity of light. |
| Throughput | Single Test Mode: 60 tests/hour<br>Continuous Test Mode: 120<br>tests/hour | Single Test Mode: 55<br>tests/hour<br>Continuous Test Mode: 120<br>tests/hour |
| Memory | Last 500 results | Last 2000 results |
| PC Port | Standard RS232C Port (cable not<br>included) | Standard RS232C Port (cable<br>not included),<br>USB Port (cable not included);<br>(Not connect to PC)<br>Bluetooth Wireless |
| Capabilities | Internal heat sensitive printer<br>(included)<br>25 Pin Parallel External Printer<br>Port (not included)<br>External printer (optional) | Internal thermal printer<br>Barcode reader Connector<br>External printer (optional)<br>Barcode reader (optional)<br>RJ45 Ethernet; (optional) |
| Power Source | 220 Volts AC (±10%), 50 Hz<br>(±1),<br>110 Volts AC (±10%), 60 Hz<br>(±1),<br>110-230 Volts AC, 50/60 Hz | 6 AA batteries with 100 tests/6<br>new batteries; 100- 240<br>VAC(adapter), (50-60 Hz±<br>1HZ) |
| Optimum<br>Operating<br>Conditions | 15-30°C (59-86°F); ≤75%<br>Relative Humidity (non-<br>condensing) | 15-30°C (59-86°F); 20-80%<br>Relative Humidity (non-<br>condensing) |
| User Interface | MKB Key based UI | Touch Screen based UI |
| Weight | 2.6 Kg (5.73 lbs.) | ≤1.66 kg (3.65 lbs.) without<br>batteries or power supply |
| Dimensions (L X<br>W X H) | 27.1 (L) x 26.5 (W) x 14.6 (H)<br>cm | 26.0 (L) x 15.0 (W) x 17.5 (H)<br>cm |
| Display<br>Dimensions (L X<br>W) | 240x128 blue and white,<br>10.6 (W) x 2.8 (H) cm | Large touch screen Color LCD<br>TFT 640x480,<br>11.7 (W) x 8.8 (H) cm |
| Appearance | Image: Mission U120 | Image: Mission U120 Ultra |

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Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are substantially equivalent to ACON's 510k cleared - Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls (K103387)

| Feature | Mission® Liquid Urine Controls,<br>Mission® Liquid Diptube Urine<br>Controls | Mission® Liquid Urine<br>Controls, Mission® Liquid<br>Diptube Urine Controls<br>(K103387) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended/Indications<br>for Use | For use as an assayed quality<br>control urine to monitor the<br>precision of urinalysis test<br>procedures for the analytes listed<br>in the package insert.<br>The Mission® Liquid Urine<br>Control and Mission® Liquid<br>Diptube Urine Control are for<br>use with the Mission® Urinalysis<br>Reagent Strips and Mission U120<br>Ultra Urine Analyzer | For use as an assayed quality<br>control urine to monitor the<br>precision of urinalysis test<br>procedures for the analytes<br>listed in the package insert.<br>The Mission® Liquid Urine<br>Control and Mission® Liquid<br>Diptube Urine Control are for<br>use with the Mission®<br>Urinalysis Reagent Strips and<br>Mission U120 Urine Analyzer<br>(K070929) |
| Levels | 2 | Same |
| Form | Liquid | Same |

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| Analytes | Glucose, Bilirubin, Ketone<br>(Acetoacetic acid), Specific<br>Gravity, Blood, pH, Protein,<br>Urobilinogen, Nitrite,<br>Leukocytes, and Ascorbic Acid | Same |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Storage | 2 to 8°C | Same |
| Matrix | Liquid Matrix Solution | Same |
| Open Vial | 24 months at 2-8°C<br>30 Days at 15-30°C | Same |
| Packaging<br>Configuration | Dropper, diptube | Same |
| Shelf Life | 24 months at 2-8°C | Same |

### Discussion of Clinical Tests Performed:

Clinical studies were conducted using the Mission® U120 Ultra Urine Analyzer and Mission® Urinalysis Reagent strips. The purpose of the study was to evaluate the performance of Mission® Urinalysis Reagent strip read by Mission® U120 Ultra Urine Analyzer compared to the predicate: Mission® Urinalysis Reagent strip read by ACON U120 Urine Analyzer (K070929); and to observe if there is any problem/issue with operation of the Mission® Urinalysis Reagent strip / Mission® U120 Ultra Urine Analyzer when they are placed in the hands of the intended user.

Approximately 120 patient urine specimens were randomly collected from patients at each of 3 clinical sites, and tested by 3 intended users at each site (total of 9 users for all 3 sites) Each specimen was tested by Mission® Urinalysis Reagent strip read with Mission® U120 Ultra Urine Analyzers and Mission® Urinalysis Reagent strip read with Mission® U120 Urine Analyzers. Each intended user tested approximately the same number of specimens at each site. The study period at each site last over 3 months. In order to evaluate the performance with the analyte covering the measuring range, few contrived urine specimens were tested at each site following the study protocol.

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Additional study was carried out at 2 sites in US; a POC site and a specialty care office for inclusion of positive samples for the Nitrite, Urobilinogen, Ketone and Bilirubin analytes. Below is the summary of the specimens tested at all sites combined:

| Test | Comparative<br>Method | N (including<br>contrived<br>samples) | % Exact<br>Agreement | % Within<br>one level<br>Agreement |
|-----------|--------------------------------------|---------------------------------------|----------------------|------------------------------------|
| Leukocyte | U120 Ultra vs U120<br>Urine Analyzer | 468 | 95.3%<br>(446/468) | 100%<br>(468/468) |
| Nitrite | U120 Ultra vs U120<br>Urine Analyzer | 451 | 100%<br>(451/451) | 100%<br>(451/451) |
| Uro | U120 Ultra vs U120<br>Urine Analyzer | 426 | 93.4%<br>(398/426) | 100%<br>(426/426) |
| Pro | U120 Ultra vs U120<br>Urine Analyzer | 468 | 92.7%<br>(434/468) | 100%<br>(468/468) |
| pH | U120 Ultra vs U120<br>Urine Analyzer | 468 | 86.8%<br>(406/468) | 100%<br>(468/468) |
| Blo | U120 Ultra vs U120<br>Urine Analyzer | 468 | 93.8%<br>(439/468) | 100%<br>(468/468) |
| SG | U120 Ultra vs U120<br>Urine Analyzer | 468 | 85.5%<br>(400/468) | 100%<br>(468/468) |
| Ketone | U120 Ultra vs U120<br>Urine Analyzer | 458 | 96.4%<br>(446/458) | 100%<br>(458/458) |
| Bil | U120 Ultra vs U120<br>Urine Analyzer | 450 | 97.4%<br>(444/450) | 100%<br>(450/450) |
| Glu | U120 Ultra vs U120<br>Urine Analyzer | 468 | 95.7%<br>(448/468) | 100%<br>(468/468) |
| ASC | U120 Ultra vs U120<br>Urine Analyzer | 468 | 90.0%<br>(421/468) | 100%<br>(468/468) |

These clinical study and statistical data demonstrated that the intended user can follow the product instruction and obtain comparable instrument read results when using the Mission®U120 Ultra Urine Analyzer and a predicate Analyzer. The clinical study results indicate that the Mission®U120 Ultra Urine Analyzer is substantially equivalent to the legally marketed device ACON U120 Urine Analyzer.

# Discussion of Performance Tests Performed:

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The performance characteristics of the Mission® U120 Ultra Urine Analyzer to read Mission® Urinalysis Reagent Strips were verified by Precision study, Interference study, Temperature flex study, voltage flex study, SG flex study, pH flex study, Humidity flex study, sensitivity study, stability study, electrical safety testing and EMC testing. Laboratory testing results indicate that the Mission® U120 Ultra Urine Analyzer is robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in the Instruction Manual and Package Insert of the device.

## Sensitivity Study:

The sensitivity of the Mission® Urinalysis Reagent Strips was determined in combination of the Mission® U120 Ultra Urine Analyzer. The low and high end range of sensitivity for Mission® Urinalysis Reagent Strips tested by Mission® U120 Ultra is listed in table below.

| Analyte | Color block | Low end sensitivity | High end<br>sensitivity |
|---------------|-------------|---------------------|-------------------------|
| Ascorbic Acid | 40 mg/dL | 30 mg/dL | >40 mg/dL |
| Ascorbic Acid | 20 mg/dL | 15 mg/dL | 27.5 mg/dL |
| Ascorbic Acid | 10 mg/dL | 5 mg/dL | 13.5 mg/dL |
| Ascorbic Acid | 0 mg/dL | 0 mg/dL | 4.5 mg/dL |
| Glucose | 1000 mg/dL | 750 mg/dL | >1000 mg/dL |
| Glucose | 500 mg/dL | 375 mg/dL | 675 mg/dL |
| Glucose | 250 mg/dL | 192.5 mg/dL | 337.5mg/dL |
| Glucose | 100 mg/dL | 50 mg/dL | 175 mg/dL |
| Glucose | 0 mg/dL | 0 mg/dL | 45mg/dL |
| Bilirubin | 4 mg/dL | 3 mg/dL | >4 mg/dL |
| Bilirubin | 2 mg/dL | 1.5 mg/dL | 2.7 mg/dL |
| Bilirubin | 1 mg/dL | 0.4 mg/dL | 1.35 mg/dL |
| Bilirubin | 0 mg/dL | 0 mg/dL | 0.35 mg/dL |
| Ketone | 80 mg/dL | 60 mg/dL | > 80 mg/dL |
| Ketone | 40 mg/dL | 27.5 mg/dL | 54 mg/dL |
| Ketone | 15 mg/dL | 11 mg/dL | 24.75 mg/dL |

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| | 5 mg/dL | 2.5 mg/dL | 10 mg/dL |
|------------------|-------------|--------------|---------------|
| | 0 mg/dL | 0 mg/dL | 2.25 mg/dL |
| Specific Gravity | 1.000~1.030 | 1.000 | 1.030 |
| Blood | 200Ery/µL | 140 Ery/µL | >200 Ery/µL |
| | 80 Ery/µL | 52.5 Ery/µL | 126 Ery/µL |
| | 25 Ery/µL | 12.5 Ery/µL | 47.25 Ery/µL |
| | 10 Ery/µL | 5 Ery/µL | 15.75 Ery/µL |
| | 0 Ery/µL | 0 Ery/µL | 4.5 Ery/µL |
| pH | 5.0~9.0 | 5.0 | 9.0 |
| Protein | 300 mg/dL | 200 mg/dL | >300 mg/dL |
| | 100 mg/dL | 65 mg/dL | 180 mg/dL |
| | 30 mg/dL | 22.5 mg/dL | 58.5 mg/dL |
| | 15 mg/dL | 7.5 mg/dL | 20.25 mg/dL |
| | 0 mg/dL | 0 mg/dL | 6.75 mg/dL |
| Urobilinogen | 8 mg/dL | 6 mg/dL | >8 mg/dL |
| | 4 mg/dL | 3 mg/dL | 5.4 mg/dL |
| | 2 mg/dL | 1.5 mg/dL | 2.7 mg/dL |
| | 1 mg/dL | 0.6 mg/dL | 1.35 mg/dL |
| | 0.2mg/dL | 0 mg/dL | 0.54mg/dL |
| Nitrite | 0.1 mg/dL | 0.05mg/dL | >0.1 mg/dL |
| | 0 mg/dL | 0 mg/dL | 0.045 mg/dL |
| Leukocyte | 500 Leu/µL | 312.5 Leu/µL | >500 Leu/µL |
| | 125 Leu/µL | 97.5 Leu/µL | 281.25 Leu/µL |
| | 70 Leu/µL | 42.5 Leu/µL | 87.75 Leu/µL |
| | 15 Leu/µL | 9 Leu/µL | 38.25 Leu/µL |
| | 0 Leu/µL | 0 Leu/µL | 8.25 Leu/µL |

# Precision Study:

The reproducibility of the Mission® U120 Ultra Urine Analyzer was evaluated using 3 levels of Control Solutions. The target concentration of the analyte in each control solution was

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confirmed with Siemens reagent strips read by Clinitek Status urine analyzer and Mission® Urinalysis Reagent Strip read by ACON U120 urine analyzer. Each control solution was tested with one lot of strip in duplicates per run, 2 runs each day by one operator for 20 days. Second operator performed the test following the same protocol with second lot and second analyzer. A total of160 strips were used for each concentration tested (2 strips x 2 run x 20 days x 2 operators= 160 strips). The precision for each device was 100% exact agreement. The results are summarized as below.

| Control | Analyte | Agreement at same block | Agreement within +/- one block |
|---------------|-----------------|-------------------------|--------------------------------|
| Level 1 | Ascorbic acid | 100% (160/160) | 100% (160/160) |
| | Glucose | 100% (160/160) | 100% (160/160) |
| | Bilirubin | 100% (160/160) | 100% (160/160) |
| | Ketone | 100% (160/160) | 100% (160/160) |
| | S.G. | 95.0% (152/160) | 100% (160/160) |
| | Blood | 100% (160/160) | 100% (160/160) |
| | pH | 97.5% (156/160) | 100% (160/160) |
| | Protein | 100% (160/160) | 100% (160/160) |
| | Urobilinogen | 100% (160/160) | 100% (160/160) |
| | Nitrite | 100% (160/160) | 100% (160/160) |
| | Level 2 | Leukocyte | 100% (160/160) |
| Ascorbic acid | | 96.9% (155/160) | 100% (160/160) |
| Glucose | | 98.1% (157/160) | 100% (160/160) |
| Bilirubin | | 97.5% (156/160) | 100% (160/160) |
| Ketone | | 98.1% (157/160) | 100% (160/160) |
| S.G. | | 95.6% (153/160) | 100% (160/160) |
| Blood | | 98.8% (158/160) | 100% (160/160) |
| pH | | 96.9% (155/160) | 100% (160/160) |
| Protein | | 96.9% (155/160) | 100% (160/160) |
| Urobilinogen | | 97.5% (156/160) | 100% (160/160) |
| Nitrite | | 100% (160/160) | 100% (160/160) |
| Leukocyte | 99.4% (159/160) | 100% (160/160) | |
| Level 3 | Ascorbic acid | 100% (160/160) | 100% (160/160) |
| | Glucose | 98.8% (158/160) | 100% (160/160) |
| | Bilirubin | 98.1% (157/160) | 100% (160/160) |
| | Ketone | 96.3% (154/160) | 100% (160/160) |
| | S.G. | 94.4% (151/160) | 100% (160/160) |
| | Blood | 99.4% (159/160) | 100% (160/160) |
| | pH | 98.1% (157/160) | 100% (160/160) |
| | Protein | 100% (160/160) | 100% (160/160) |
| | Urobilinogen | 98.1% (157/160) | 100% (160/160) |
| | Nitrite | 100% (160/160) | 100% (160/160) |
| | Leukocyte | 98.1% (157/160) | 100% (160/160) |

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Precision Studies were also performed by testing each level of control solution by a single operator in 20 replicates per run per day with each lot on U120 Ultra. Operator 3 followed the same procedure with different lots of strips on different Mission® U120 Ultra Analyzers. A total of 180 strips were used for each concentration tested (20 strips x 3 lots x 3 analyzers (3 operators) x 1day = 180 strips. The precision for each device was 100% exact agreement. The results are summarized as below.

| Control Level | Analyte | Agreement at same block | Agreement within +/- one block | |
|-------------------------------------|---------------|-------------------------|--------------------------------|--|
| | Ascorbic acid | 100% (180/180) | 100% (180/180) | |
| Glucose100% (180/180)100% (180/180) | | | | |
| | Bilirubin | 100% (180/180) | 100% (180/180) | |
| | Ketone | 100% (180/180) | 100% (180/180) | |
| | S.G. | 95.6% (172/180) | 100% (180/180) | |
| Level 1 | Blood | 100% (180/180) | 100% (180/180) | |
| | pH | 97.2% (175/180) | 100% (180/180) | |
| | Protein | 100% (180/180) | 100% (180/180) | |
| | Urobilinogen | 100% (180/180) | 100% (180/180) | |
| | Nitrite | 100% (180/180) | 100% (180/180) | |
| | Leukocyte | 100% (180/180) | 100% (180/180) | |

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| | Ascorbic acid | 97.8% (176/180) | 100% (180/180) |
|---------|---------------|-----------------|----------------|
| | Glucose | 96.7% (174/180) | 100% (180/180) |
| | Bilirubin | 97.2% (175/180) | 100% (180/180) |
| | Ketone | 97.2% (175/180) | 100% (180/180) |
| | S.G. | 92.2% (166/180) | 100% (180/180) |
| Level 2 | Blood | 95.6% (172/180) | 100% (180/180) |
| | pH | 93.9% (169/180) | 100% (180/180) |
| | Protein | 97.2% (175/180) | 100% (180/180) |
| | Urobilinogen | 95.5% (172/180) | 100% (180/180) |
| | Nitrite | 100% (180/180) | 100% (180/180) |
| | Leukocyte | 98.3% (177/180) | 100% (180/180) |
| | Ascorbic acid | 98.9% (178/180) | 100% (180/180) |
| | Glucose | 93.3% (168/180) | 100% (180/180) |
| | Bilirubin | 97.2% (175/180) | 100% (180/180) |
| | Ketone | 97.8% (176/180) | 100% (180/180) |
| | S.G. | 97.8% (176/180) | 100% (180/180) |
| Level 3 | Blood | 96.7% (174/180) | 100% (180/180) |
| | pH | 93.9% (169/180) | 100% (180/180) |
| | Protein | 98.9% (178/180) | 100% (180/180) |
| | Urobilinogen | 97.8% (176/180) | 100% (180/180) |
| | Nitrite | 100% (180/180) | 100% (180/180) |
| | Leukocyte | 97.8% (176/180) | 100% (180/180) |

# Interference Substances:

The effect of interfering substances commonly found in urine on Mission® Urinalysis Reagent Strips when read by Mission® U120 Ultra Urine Analyzers was studied by preparing 3 levels of controls for each analyte present in the urine and tested with one urine strip on one analyzer following the product insert. Total 3 lots of urine test strips and 3 urine analyzers were used for the study. The following substances were found to interfere with the testing results.

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| Reagent pad | Interference<br>substances | Conc. | U120 Ultra analyzer |
|------------------|----------------------------|-------------|-------------------------|
| Glucose | Ascorbic acid | ≥25 mg/dL | False decreased results |
| Glucose | Ketone (Acetoacetate) | ≥100 mg/dL | False decreased results |
| Bilirubin | Ascorbic acid | ≥50 mg/dL | False decreased results |
| Bilirubin | Blood | ≥5% | False increased results |
| Ketone | Blood | ≥5% | False increased results |
| Specific gravity | Protein (Albumin) | ≥300 mg/dL | False increased results |
| Blood | Ascorbic acid | ≥50 mg/dL | False decreased results |
| Urobilinogen | Nitrite | ≥10 mg/dL | False decreased results |
| Protein | Hemoglobin | ≥20 mg/dL | False increased results |
| Protein | Blood | ≥0.05% | False increased results |
| Urobilinogen | Blood | ≥5% | False increased results |
| Nitrite | Ascorbic acid | ≥30 mg/dL | False decreased results |
| Nitrite | Blood | ≥1% | False increased results |
| Leukocyte | Glucose | ≥2000 mg/dL | False decreased results |
| Leukocyte | Blood | ≥0.05% | False increased results |

# Temperature Flex Study:

The optimal temperature range for performing the test of Mission® Urinalysis Reagent Strip by Mission® U120 Ultra Urine Analyzer was validated at temperature 2°C to 45°C by performing the test at different temperatures in 5 replicates for each sample.

# Humidity Flex Study:

50 strips were stored in different humidity environments and tested with Mission® U120 Ultra Urine Analyzer at different time points. The time that the strips was stable after exposed to the different storage condition is listed in the following table:

| Reagent strips | Humidity of the storage conditions | The time that the strips was stable after<br>exposed to the different storage<br>condition |
|------------------|------------------------------------|--------------------------------------------------------------------------------------------|
| Ascorbic acid | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Glucose | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | 8h |
| | >80% | 4h |
| Bilirubin | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Ketone | <20% | >24h |
| | 30-50% | 16h |
| | 60-70% | 2h |
| | >80% | 2h |
| Specific Gravity | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Blood | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | 16h |
| | >80% | 4h |
| pH | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Protein | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Urobilinogen | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Nitrite | <20% | >24h |
| | 30-50% | 16h |
| | 60-70% | 1h |
| | >80% | 0.5h |
| Leukocyte | <20% | >24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | 8h |

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### Voltage Flex Study:

The voltage flex study was performed using Mission® Liquid urine control, Level 1(normal) and Level 2 (abnormal) on analyzers supplied with the following voltages: 86V, 100V and 264V. 220V was also tested as the baseline control condition. Three analyzers were turned on using each of the voltage, and tested to see if the analyzer works properly. The analyzers were tested three times under each voltage. Mission® U120 Ultra urine analyzer can operate properly under 86V, 100V and 264V, and the test results are comparable to those of the 220V baseline control results. In conclusion, the range from 86V to 264V is suitable for operation of the Mission® U120 Ultra urine analyzer.

### pH Flex Study:

5 normal fresh urines were collected and mixed. The mixed urine was tested with Siemens Clinitek Status and ACON U120 urine analyzer to determine the concentrations in the pooled urine. The Leu, Nit, Uro, Pro, Blo, Ket, Bil, Glu and Asc in the pooled urine were negative with pH at 6.5 and SG at 1.010. The mixed urine samples were split into five aliquots (150 ml / each glass container). Adjust these five aliquots urine pH to 5, 6, 7, 8, 9 with 1M Hydrochloric acid aqueous and 1M Sodium hydroxide aqueous. Then spiked analytes to different concentration as control Level 1, Level 2 and Level 3 listed in the table. The concentrations of each analyte in the control at pH 6 were confirmed with 510(k) cleared Siemens Clinitek Status and U120 urine analyzer, the results were used as expected values. Test these control solutions

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with Mission® Urinalysis Reagent strips by Mission U120 Ultra analyzer following the product inserts. 5 replicates were tested for each sample.

Sample pH from 5.0 to 9.0 does not affect the results of Urobilinogen, Ketone, Bilirubin, and Glucose tests. Sample pH>8 would generate false high results on Protein test. Sample pH>9 would generate false high results on Leukocyte and Specific Gravity test, and false low results on Nitrite, Blood, Ascorbic acid test.

## Urine Controls Validation:

## Value Assignment

Control value assignment for the Mission Liquid Urine Control and Mission Liquid Diptube Urine Control was done by testing Level 1 and Level 2 using the Mission Urinalysis Reagent Strips tested on the Mission U120 Ultra Urine analyzer. Three lots of strips and three analyzers were tested for three consecutive days by three operators. All results for level 1 were negative except for SG and pH which should be +/- 2 color blocks of target results and all results for level 2 showed positive results except for ascorbic acid.

### Stability Studies

Accelerated, Real Time and Open Stability studies were performed to test the shelf life of Mission Liquid Urine Control and Mission Liquid Diptube Urine Control under different conditions. Accelerated stability study confirmed that the product is stable at 2-8℃ for 24 months when stored properly in unopened bottles. Real Time Stability study confirmed the shelf life of the controls is 24 month. Open Canister Stability study confirmed that the controls remain stable for up to 30 days at 15-30°C and 24months at 2-8°C after being opened.

#### Conclusion:

The laboratory testing results and clinical studies demonstrate that the Mission® U120 Ultra Urine Analyzer is safe, effective and easy-to-use and such is substantially equivalent to the ACON U120 Urine Analyzer (K070929), currently sold on the U.S. market for professional (point-of-care) testing.