iChemVELOCITY Automated Urine Chemistry System

K171083 · Iris Diagnostics, A Division of Iris International, Inc. · JIL · May 12, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171083
• Device Name: iChemVELOCITY Automated Urine Chemistry System
• Applicant: Iris Diagnostics, A Division of Iris International, Inc.
• Product Code: JIL · Clinical Chemistry
• Decision Date: May 12, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.

Device Story

Automated urine chemistry analyzer; processes urine samples via test strips and optical modules. Inputs: urine samples in test tubes; light reflectance from test strips; light transmittance/scattering through urine for color/clarity; refractive index for specific gravity. Operation: Strip Reader Module (SRM) measures reflectance; Color/Clarity Module (CCM) measures light transmission/scattering via color sensor; Specific Gravity Module (SGM) measures refractive index. Output: quantitative specific gravity; semi-quantitative chemistry results; qualitative color/clarity. Used in clinical laboratories; operated by lab personnel. Output displayed to clinicians to aid diagnosis of metabolic, renal, urinary, and liver conditions. Design change involves replacing end-of-life color sensor (TCS230 to TCS3200) and scatter LED, with updated firmware algorithm for color detection.

Clinical Evidence

Bench testing only. Method comparison and precision studies performed. Method comparison evaluated color/clarity results against the predicate; precision studies (n=240 per level) demonstrated high exact agreement (95-100%) and 100% agreement within ±1 block for all color and clarity categories.

Technological Characteristics

Automated urine chemistry analyzer. CCM utilizes Taos TCS3200 color sensor and Luxeonstar/Lumileds SR-01-WC100 scatter LED. Specific gravity measured via refractive index. SRM measures light reflectance. Microcontroller (PIC 18F25) uses UART communication. Firmware implements color detection using HSL color space and Ohta Color plane. Powered by internal switching mode power supply (AC to DC).

Indications for Use

Indicated for clinical laboratory use to automate urine chemistry analysis in patients requiring diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Not for Point of Care (POC) use.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Submission Summary (Full Text)

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

May 12, 2017

IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL NANCY NADLER DIRECTOR, REGULATORY AFFAIRS 9172 ETON AVE CHATSWORTH, CA 91311

Re: K171083

Trade/Device Name: iChemVELOCITY Automated Urine Chemistry System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JRE, JMA, KQO Dated: April 10, 2017 Received: April 11, 2017

Dear Nancy Nadler:

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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR 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.

**Kellie B. Kelm -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) k171083

#### Device Name

iChem®VELOCITY™ Automated Urine Chemistry System

#### Indications for Use (Describe)

The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iO®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.

iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.

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

| <div> <object data="data:image/svg+xml;utf8,%3Csvg width='16' height='16' viewBox='0 0 16 16' fill='none' xmlns='http://www.w3.org/2000/svg'%3E%3Cpath d='M14.6667 2.66663L13.3333 1.33329L8 6.66663L2.66667 1.33329L1.33333 2.66663L6.66667 7.99996L1.33333 13.3333L2.66667 14.6666L8 9.33329L13.3333 14.6666L14.6667 13.3333L9.33333 7.99996L14.6667 2.66663Z' fill='black'/%3E%3C/svg%3E" height="16" type="image/svg+xml" width="16"></object> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> <object data="data:image/svg+xml;utf8,%3Csvg width='16' height='16' viewBox='0 0 16 16' fill='none' xmlns='http://www.w3.org/2000/svg'%3E%3Crect x='0.5' y='0.5' width='15' height='15' rx='2.5' stroke='black'/%3E%3C/svg%3E" height="16" type="image/svg+xml" width="16"></object> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the text "BECKMAN" on the first line and "COULTER" on the second line. The text is in a bold, sans-serif font.

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# 510(k) Summary for iChem®VELOCITY™ Automated Urine Chemistry System – CGM Design Change

#### 510(k) Owner / Submitter Information

Nancy Nadler Director, Regulatory Affairs Iris Diagnostics, a Division of Iris International 9172 Eton Avenue Chatsworth, California 91311 Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Submitted: April 10, 2017

## Device Information

Trade Name: iChem® VELOCITY™ Automated Urine Chemistry System Common Name: Urine Chemistry Analyzer

| Classification Name | Product<br>Code | Device<br>Class | Regulation<br>Number |
|------------------------------------------------------------------------|-----------------|-----------------|----------------------|
| Urinary glucose (non-quantitative) test<br>system | JIL | II | 21 CFR§862.1340 |
| Occult blood test | JIO | II | 21 CFR§864.6550 |
| Urinary urobilinogen (non-<br>quantitative) test system | CDM | I | 21 CFR§862.1785 |
| Urinary bilirubin and its conjugates<br>(non-quantitative) test system | JJB | I | 21 CFR§862.1115 |
| Ketones (non-quantitative test system) | JIN | I | 21 CFR§862.1435 |
| Urinary protein or albumin (non-<br>quantitative) test system | JIR | I | 21 CFR§862.1645 |
| Nitrite (non-quantitative) test system | JMT | I | 21 CFR§862.1510 |
| Leukocyte peroxidase test | LJX | I | 21 CFR§864.7675 |
| Urinary pH (non-quantitative) test<br>system | CEN | I | 21 CFR§862.1550 |
| Refractometer for Clinical Use | JRE | I | 21 CFR§862.2800 |
| Ascorbic Acid Test System | JMA | I | 21 CFR§862.1095 |
| Automated Urinalysis System | KOO | I | 21 CFR§862.2900 |

#### Table 1: Regulatory Information

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Image /page/4/Picture/0 description: The image contains the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" stacked on top of each other in black, bold font. The logo is simple and modern, with a focus on the company's name.

| Candidate | Predicate | Manufacturer | 510(k) No. | Date Cleared |
|------------------------------------------|---------------|--------------------------------------------------------------|------------|--------------|
| iChemVELOCITY<br>with re-designed<br>CGM | iChemVELOCITY | Iris Diagnostics,<br>a Division of Iris<br>International Inc | K101852 | 03/23/2011 |

#### Predicate Device Information

## Device Description

The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance, in addition the iChemVELOCITY measures color and clarity using light transmittance through Color/Clarity Module (CCM) and specific gravity using refractive index through Specific Gravity Module (SGM).

The subject of this submission is a design change to the Color/Clarity Module (CCM) of the Color/Clarity/Specific Gravity Module (CGM) subassembly of the iChemVELOCITY. The CCM measures the color and clarity of a urine sample using transmitted and scattered light, incident on a color sensor. An algorithm then converts the output of the different channels of the sensor into semi-quantitative colors. The CCM is being changed to replace end-of-life components (color sensor and scatter light source) and update the color detection algorithm.

### Intended Use/Indications for Use:

The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY TM Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.

These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.

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Image /page/5/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN COULTER" is written in bold, black letters, with "BECKMAN" on the top line and "COULTER" on the bottom line.

Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.

### Comparison to Predicate

The design change applied to the CCM is to replace the color sensor Taos TCS230 with Taos TCS3200 color sensor, along with the scatter LED due to end-of-life of the components. These components were chosen because of their similar characteristics to the components they replace. In addition to the electronic components, new firmware has been written and installed on the CCM's microprocessor to control the new components and to update the CCM algorithm.

Color and clarity result categories are not changed with this design change, and the change is fit and functionally compatible with the subassembly as cleared in K101852. The CCM change is intended to provide a substantially equivalent subassembly with equivalent output to the original design as cleared in K101852.

Similarities and Differences between iChemVELOCITY as cleared in K101872 and the iChemVELOCITY with the redesigned CCM are shown in the table below.

| | iChemVELOCITY Analyzer<br>K101852 (cleared on 3/23/2011) | Proposed Device<br>iChemVELOCITY with<br>Redesigned CCM |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The iChem® VELOCITY™<br>automated urine chemistry system is<br>an in vitro diagnostic device used to<br>automate the urine chemistry<br>analysis profile using iChem®<br>VELOCITY ™ Urine Chemistry<br>Strips. The iChemVELOCITY can<br>be used as a stand-alone system, as<br>well as in an iQ®200 Series system,<br>a configuration given the proprietary<br>name iRICELL™ as it is designed to<br>be hardware and software<br>compatible with iQ200 Series<br>systems. It produces quantitative<br>results for specific gravity; semi-<br>quantitative results for glucose,<br>blood, leukocyte esterase, bilirubin,<br>urobilinogen, pH, protein, ketones<br>and ascorbic acid; and qualitative | Same |
| | iChemVELOCITY Analyzer<br>K101852 (cleared on 3/23/2011) | Proposed Device<br>iChemVELOCITY with<br>Redesigned CCM |
| | results for nitrites, color and clarity.<br>iChemVELOCITY strips are<br>intended for use only with the<br>iChemVELOCITY analyzer. In<br>particular, they are not intended for<br>visual reading. The<br>iChemVELOCITY is not intended to<br>be used as a Point of Care (POC)<br>analyzer. | |
| | These measurements are used to aid<br>in the diagnosis of metabolic<br>disorders, kidney function<br>anomalies, urinary tract infections,<br>and liver function. Tests performed<br>using the iChemVELOCITY are<br>intended for clinical laboratory and<br>in vitro diagnostic use only. | |
| Specimen<br>analyzed | Urine collected in cup or other<br>container, and transferred to a tube for<br>sampling onto iChemVELOCITY test<br>strips. | Same |
| Method of<br>Operation | Color change on the pads of the<br>iChemVELOCITY strips are analyzed<br>for percent reflectance and converted to<br>results through an algorithm<br>Urine color and clarity are obtained by<br>measuring absorbance or scattering of<br>white light through a flowcell.<br>Intensities of RGB wavelengths are<br>measured with a solid-state<br>photodetector array.<br>Specific gravity is measured by<br>determining the refractive index of the<br>specimen | Same |
| Energy Source | AC power is converted to DC by an<br>internal switching mode power supply | Same |
| | iChemVELOCITY Analyzer<br>K101852 (cleared on 3/23/2011) | Proposed Device<br>iChemVELOCITY with<br>Redesigned CCM |
| Color Sensor | Taos TCS230 | Taos TCS3200<br>Due to an obsolescence of the<br>sensor |
| Scatter LED | Luxeonstar/Lumileds LXHL-LW3C | Luxeonstar/Lumileds SR-01-<br>WC100 |
| Microcontroller | PIC 18F25 | Same |
| Board<br>communications | UART | Same |
| Firmware | The CCM measures the light intensity<br>in RGB channels. Then it corrects each<br>channel using iChemVELOCITY wash<br>solution as a reference source. The<br>compensated RGB data is converted to<br>project in 2 dimensional HSL color<br>plane | Same method for the HSL color<br>space, however boundaries for<br>color bins were modified and an<br>Ohta Color plane was added to<br>refine color measurements along<br>the boundaries of the HSL<br>calculations. |
| Result format | Semi-quantitative results are presented<br>for color and clarity. Specifically: | Same |
| | Color - Red, Blue, Amber, Yellow,<br>Straw, and Colorless | |
| | Clarity - Turbid, Cloudy, Slightly<br>Cloudy, and Clear | |

### Table 2: Comparison Between Proposed Device and Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular symbol with two curved white lines inside, resembling an abstract representation of a wave or a double helix. To the right of the symbol, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.

iris

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Image /page/7/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name "BECKMAN COULTER" in bold, black letters. The word "BECKMAN" is stacked on top of the word "COULTER".

Image /page/7/Picture/1 description: The image shows the word "Iris" in a stylized, sans-serif font. The letters are in a gray color, and the word is slightly slanted to the right. The "i" is lowercase, and the rest of the letters are also lowercase. The word appears to be a logo or brand name.

### Substantial Equivalence Conclusion

In order to demonstrate substantially equivalent performance of the proposed device to the predicate device for this design change, verification studies were designed and performed to ensure that the fit of the CCM in the iChemVELOCITY remained unchanged, and that the function of the CCM produced equivalent results to the predicate design. All testing successfully passed the acceptance criteria, and the test results demonstrated equivalence to the predicate.

In addition, no new hazards were introduced with the implementation of this change and therefore safety associated with the operation of this device remains unchanged.

In summary, the iChemVELOCITY with the redesigned CCM is substantially equivalent to the predicate device in regard to safety, effectiveness, and performance characteristics.

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Image /page/8/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized representation of a wave or a double helix. To the right of the circle, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.

## Summary of Performance Data

This design change is transparent to the user and does not alter any performance claims of the device. Various tests were conducted on the redesigned CCM to verify that fit and function of the subassembly did not impact the user experience or the performance characteristics of the iChemVELOCITY system. Verification studies were designed based on the risk analysis to verify that the proposed design performed better or equivalently to the predicate.

Performance testing of the iChemVELOCITY with the redesigned CCM was conducted to ensure that the system as a whole demonstrates equivalent performance to the predicate design. This testing included:

- o Method Comparison
- Precision o

### Performance Test Summary

#### Table 3: Method Comparison Results Summary

| | | Comparator | | | | | |
|-------------------|-----------|------------|--------|--------|--------|--------|--------|
| Redesigned<br>CCM | Blue | | | | | 18 | |
| | Red | | | | 3 | 18 | |
| | Amber | | | | 5 | 18 | |
| | Yellow | | 11 | | 61 | 9 | |
| | Straw | | 13 | | | | |
| | Colorless | | 18 | 12 | | | |
| | | Colorless | Straw | Yellow | Amber | Red | Blue |
| Exact match: | | 100.0% | 36% | 92% | 60.0% | 100.0% | 100.0% |
| ± 1 Block: | | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |

| | | Comparator | | | |
|-------------------|-----------------|------------|--------------------|--------|--------|
| Redesigned<br>CCM | Turbid | | | | 32 |
| | Cloudy | | 1 | 22 | 1 |
| | Slightly Cloudy | | 7 | 13 | |
| | Clear | 87 | 16 | 1 | |
| | | Clear | Slightly<br>Cloudy | Cloudy | Turbid |
| Exact match: | | 100.0% | 29.2% | 61.1% | 97.0% |
| | ± 1 Block: | 100.0% | 100.0% | 97.2% | 100.0% |

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Image /page/9/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" in bold black letters above the word "COULTER" in bold black letters. To the left of the logo is a short black line.

| Color/Clarity | Test level | Number | | | % Exact<br>agreement | % ±1 block<br>agreement |
|---------------|-----------------|--------|----------------|-------------------|----------------------|-------------------------|
| | | Total | Exact<br>agree | ±1 block<br>agree | | |
| Color | Colorless | 240 | 240 | 240 | 100% | 100% |
| | Straw | 240 | 238 | 240 | 99.2% | 100% |
| | Yellow | 240 | 240 | 240 | 100% | 100% |
| | Amber | 240 | 240 | 240 | 100% | 100% |
| | Red | 240 | 237 | 239 | 98.8% | 99.6% |
| | Blue | 240 | 240 | 240 | 100% | 100% |
| Clarity | Clear | 240 | 240 | 240 | 100% | 100% |
| | Slightly Cloudy | 240 | 228 | 240 | 95.0% | 100% |
| | Cloudy | 240 | 240 | 240 | 100% | 100% |
| | Turbid | 240 | 240 | 240 | 100% | 100% |

## Table 4: Precision Results Summary

#### Conclusion

Testing results verified that the iChemVELOCITY with the redesigned CCM produced results within the performance characteristics of the device and did not negatively impact the user experience.

The data presented in this Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.

The testing results confirmed that the redesigned CCM was fit, functionally compatible and equivalent to the original CCM.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.