URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

K182038 · Yd Diagnostics Corporation · JFY · Dec 10, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182038
• Device Name: URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
• Applicant: Yd Diagnostics Corporation
• Product Code: JFY · Clinical Chemistry
• Decision Date: Dec 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and creatinine and the determination of the ACR (albumin creatinine ratio). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results. The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and creatinine, and can only be read on the URiSCAN Optima urine analyzer. The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for prescription use only, in clinical laboratory and in point-of-care settings.

Device Story

System consists of URiSCAN 10ACR reagent strips and URiSCAN Optima urine analyzer. Strips contain chemical test pads that undergo color changes upon reaction with urine analytes. Analyzer uses optical sensors to detect color changes on test pads; processes signals to determine qualitative/semi-quantitative results for blood, ketones, protein, nitrite, glucose, pH, SG, leucocytes, albumin, and ACR. Used in clinical labs and point-of-care settings by healthcare professionals. Results displayed and printed for clinical review. Assists in diagnosis/monitoring of renal, urinary, and metabolic conditions.

Clinical Evidence

No clinical trials performed. Bench testing only. Precision/reproducibility studies conducted at three POC sites using 407 natural patient samples compared against predicate devices. Results showed high agreement (exact agreement and within one block) across all analytes. No clinical sensitivity/specificity data required.

Technological Characteristics

System comprises reagent test strips and an optical reflectance-based urine analyzer. Analyte detection via colorimetric reaction on test pads. Analyzer utilizes optical sensors to measure reflectance/color change. Connectivity includes display and print output capabilities. Software-controlled analysis of test pad color intensity.

Indications for Use

Indicated for in vitro qualitative and semi-quantitative measurement of urine parameters (blood, ketones, protein, nitrite, glucose, pH, SG, leucocytes, albumin) and albumin-creatinine ratio (ACR) in clinical laboratory and point-of-care settings for evaluation of renal, urinary, and metabolic disorders. Prescription use only.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 10, 2018

YD Diagnostics Corporation % Erika Ammirati, Regulatory Consultant Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022

Re: K182038

Trade/Device Name: URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY, JIL, JIO, LJX, JIR, JMT, CEN, JRE, JIN, KQO Dated: September 11, 2018 Received: September 12, 2018

Dear Erika Ammirati:

We have reviewed vour 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. 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 located 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.

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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

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) K182038

Device Name

URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer

## Indications for Use (Describe)

The URiSCAN 10 ACR urine strips on the URiSCAN Optima urine analyzer are intended for the in vitro qualitative and semi-quantitative measurement of the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and the determination of the ACR (albumin creatinine ratio). These measurements are useful in the evaluation of renal, urinary and metabolic disorders.

The URiSCAN Optima urine analyzer is intended to read the color change on the test pads found on the URiSCAN 10ACR urine strips and to display and print the results.

The URiSCAN 10ACR urine strips include test pads for the following parameters: blood, ketones (acetoacetic acid), protein, nitrite, glucose, pH, SG (specific gravity), leucocytes, albumin and can only be read on the URiSCAN Optima urine analyzer.

The URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer are intended for prescription use only, in clinical laboratory and in point-of-care settings.

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

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