The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.

Device Description

The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The Scanostics UTI Check Application measures the colour developed in two reaction zones (leukocytes and nitrite pads) on the UTI test strip following application of a urine sample. The developed colors are then compared to calibration colours located on the Scanostics backing material and the result for each pad is determined based on the minimum colour distance between the developed colours and calibration colours.

The URS-2L UTI Test Strip comprises of two reagent pads areas, which are absorbent material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive.

The backing card comprises of thirty-two (32) calibration colour blocks and three (3) black and white alignment squares printed onto a rigid card stock and die cut to provide a groove for the strip (preventing strip misalignment). The use of the backing card is primarily to compensate for different lighting environments as it allows the calibration colours and the test strip to be subjected to the same conditions as the reagent pads for comparison - this would not be possible if the calibration colours were stored within the application itself.

The representative platform for the test system is the iPhone 6 with iOS 9. The application has been proven to be compatible on the iPhone 6S (iOS 9) and iPod touch (8th gen with iOS 8 and iOS 9). The application's core technology is based on four (4) patents held by Teco Diagnostics (US 8655009, 8877140, 8911679 and 8506901).

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Scanostics UTI Check Application Test System.

Please note: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings rather than presenting the full study report. Therefore, some information like specific statistical metrics for acceptance criteria and the exact number of participants in all study phases might not be explicitly detailed.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%). Instead, it indicates that the device should perform "comparably" to the predicate device in the hands of lay users and "satisfactorily" in non-clinical studies. The ultimate acceptance criterion implicitly relies on the demonstration of substantial equivalence to the legally marketed predicate device, Clinistrip (URS-10).

Acceptance Criteria (Implicit)	Reported Device Performance
Obtain comparable testing data to a trained HCP using predicate device	"Results indicate that the intended users were able to obtain comparable testing data when using the Scanostics UTI Check Application as a trained HCP using the Clinistrip (URS-10)." This implies that the performance in the hands of lay users matches that of a healthcare professional using the established predicate. The specific metrics (e.g., positive agreement, negative agreement) are not provided in this summary.
Satisfactory performance in non-clinical studies	"Testing results indicate that the Scanostics UTI Check application test system performs satisfactorily when used appropriately." This covers method comparison, precision, detection limit, interference, specificity, shelf life and stress studies, and several flex studies, but specific quantitative results or thresholds are not detailed.
Substantial equivalency to predicate device	"The study results demonstrate a substantial equivalency on performance between the Scanostics UTI Check application test system and the predicate device, Clinistrip (URS-10) test strips." This is the overarching conclusion of the submission.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for specific metrics like sensitivity/specificity studies. The "lay user studies were performed at three sites," suggesting a multicenter approach, but the number of participants or urine samples is not provided in detail.
- Data Provenance: The document does not specify the country of origin of the data. It seems to be a prospective study, as it describes "lay user studies were performed," implying new data collection rather than retrospective analysis.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies a comparison against "a trained HCP using the Clinistrip (URS-10)" as a reference for the lay user study. However, it does not specify the number of HCPs, their qualifications, or how a definitive "ground truth" was established for each sample (e.g., if a definitive culture result was also used). Given the nature of a 510(k) submission focusing on substantial equivalence, the "ground truth" for the test set often stems from the established predicate device's performance.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not described in the provided text.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study in the traditional sense was not performed. This device is an AI-powered reader for a diagnostic strip, intended for over-the-counter home use only by lay users. The comparison was between the lay user with the Scanostics app and a "trained HCP using the Clinistrip (URS-10)" (the predicate device). The focus is on enabling accurate interpretation by lay users, not improving expert reader performance.
- Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in the context of this study design as presented.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "Scanostics UTI Check Application test system" inherently involves the app (algorithm) reading the test strip. The "lay user studies" describe the performance when the human (lay user) operates the system. However, the non-clinical studies ("method comparison, precision, detection limit, interference, specificity, shelf life and stress studies as well as several flex studies") would largely assess the standalone performance of the algorithm's ability to read the strips under various controlled conditions, separate from a human's interpretation error. The document states these studies found the device performers "satisfactorily," implying the algorithm itself functions as intended.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth for comparison in the lay user study appears to be the results obtained by a "trained HCP using the Clinistrip (URS-10)" (the predicate device). For the non-clinical studies, the "ground truth" would likely be established through controlled laboratory testing with known concentrations for precision, detection limit, specificity, etc., but this is not explicitly detailed. It does not mention pathology or outcomes data as direct ground truth for this device's performance.
The sample size for the training set:
- The document does not provide information about the sample size used for the training set of the Scanostics UTI Check Application's algorithm.
How the ground truth for the training set was established:
- This information is not provided in the 510(k) summary. Training set ground truth would typically be established through expertly-read images of a large number of test strips, potentially correlated with laboratory-confirmed analyte concentrations, but these details are absent.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 21, 2017

TECO DIAGNOSTICS LING KOH R&D ENGINEER 1268 N LAKEVIEW AVE ANAHEIM CA 92807

Re: K170118

Trade/Device Name: Scanostics UTI Check Application Test System Regulation Number: 21 CFR 862.1510 Regulation Name: Nitrite (nonquantitative) test system Regulatory Class: I, meets the limitations of exemptions 21 CFR 862.9(c)(9) Product Code: JMT, LJX, KOO Dated: August 9, 2017 Received: August 16, 2017

Dear Ling Koh:

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 (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.

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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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

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) K170118

Device Name

Scanostics UTI Check Application test system

Indications for Use (Describe)

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

|--|--|

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black font.

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com

Section 5 - 510(k) Summary

This Summary of 510(k) Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

Owner's Name Teco Diagnostics

Poco Diagnostics

Address and Contact Information:

1268 N Lakeview Ave Anaheim, CA 92807

Contact:

Ling Koh

Date Prepared:

9 August 2017

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Image /page/4/Picture/1 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black.

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com

A. 510(k) Number: K170118
B. Analytes: Urinary leukocytes, nitrites
C. Type of Test: Semi-quantitative colorimetric test strips
D. Applicant: Teco Diagnostics
E. Trade Name: Teco Diagnostics Scanostics UTI Check Application Test System
F. Common Name:

Urine Reagent Strips (URS)

G. Regulatory Information:

1. Regulation Classification Section:
  Class I: 21 CFR 864.7675 (meets the limitations of exemptions per 21 CFR 864.9 (c)(9))- Leukocyte peroxidase test.) Class I: 21 CFR 862.1510 (meets the limitations of exemptions per 21 CFR 862.9 (c)(9))- Nitrite (non-quantitative) test system Class I: 21 CFR 862.2900 – Automated urinalysis system
Product Code: 2.
LJX - Leukocyte peroxidase test JMT - Nitrite (nonquantitative) test system) KQO
1. Panel:
  Hematology for LJX Clinical Chemistry for JMT

H. Intended Use:

The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over- the-counter home use only.

I. Device Description:

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Image /page/5/Picture/1 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black font.

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com

J. Substantial Equivalence Information:

1. Predicate device name(s): Clinistrip 10SGL
Predicate K number(s) 2. K970250
1. Compare with predicate:

Table 5.1 Scanostics UTI Check Application vs Clinistrip

Similarities
Item	Scanostics UTI Check	Clinistrip
Intended use	Over the counter, in vitro diagnosticonly	Point-of-care, invitro diagnosticuse only
Testing parameters	Nitrite and leukocytes	10 parametersincluding nitriteand leukocytes

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Image /page/6/Picture/1 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black font.

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com

Intended specimen	Urine (midstream)	Urine (collected)
Test strip	Plastic strips affixed with reagent pads	Same
Nitrite methodology	This test relies on the conversion ofnitrate to nitrite by the action of p-arsanilic acid to form a diazoniumcompound in an acid medium. Thiscompound in turn couples with 1, 2, 3, 4- tetrahydrobenzo(h) quinolin to producea pink color.	Same
Leukocyte methodology	This test is based on the hydrolysis of anindoxyl ester derivative through theaction of leukocyte esterase. Theliberated indoxyl ester reacts with adiazonium salt to produce a coloredcompound (pink to purple).	Same

Differences
Item	Scanostics	Clinistrip
Imaging system	Smartphone camera	Eye
Accessory items	Smartphone, backing card	None
Calibration method	Calibration colours provided on backingcard	Strip compared tocolour chart onbottle
Operating interface	Touch screen	None
Data collection/storage	Application has the capability to storeboth the results and the image captured.Users may retrieve stored results with apassword and share results via email.	None
Dimensions	Test strip: 10 mm x 80 mmBacking card: 50 mm x 80 mmSmartphone (depending on model):115 mm x 59 mm x 7 mm and larger	Test strip: 5 mmx 110 mm
Weight	Test strip: 0.8 gBacking card: 2.2 g	Test strip: 0.32g

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Image /page/7/Picture/1 description: The image shows the logo for Teco Diagnostics. The logo consists of a green hexagon with the letters "TC" in white inside of it. To the right of the hexagon is the text "Teco Diagnostics" in black.

	Smartphone: 110 g and up
Power	Smartphone powered by rechargeablelithium ion battery	None

The candidate device (application and test strips) uses the same chemical formulation for leukocyte and nitrite reagent pads as the predicate. The main difference between the investigational and predicate device is the inclusion of the smartphone accessory and the backing card.

K. Test Principle:

Leukocytes: This test is based on the hydrolysis of an indoxyl ester derivative through the action of leukocyte esterase. The liberated indoxyl ester reacts with a diazonium salt to produce a colored compound (pink to purple).

Nitrite: This test relies on the conversion of nitrate to nitrite by the action of p-arsanilic acid to form a diazonium compound in an acid medium. This compound in turn couples with 1, 2, 3, 4 tetrahydrobenzo(h) quinolin to produce a pink color.

L. Clinical Performance Characteristics:

The lay user studies were performed at three sites using the Scanostics UTI Check Application test system and the Clinistrip (URS-10) strips. Lay user data was presented to evaluate the accuracy of results in the hands of users and to ensure that the intended users were able to understand and implement smartphone technology.

Results indicate that the intended users were able to obtain comparable testing data when using the Scanostics UTI Check Application as a trained HCP using the Clinistrip (URS-10).

M. Non-clinical studies:

The performance characteristics of the Scanostics UTI Check Application test system were verified by method comparison, precision, detection limit, interference, specificity, shelf life and stress studies as well as several flex studies. Testing results indicate that the Scanostics UTI Check application test system performs satisfactorily when used appropriately.

N. Conclusion:

The study results demonstrate a substantial equivalency on performance between the Scanostics UTI Check application test system and the predicate device, Clinistrip (URS-10) test strips.

Regulation Number and Section

§ 862.1510 Nitrite (nonquantitative) test system.

(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Acceptance Criteria and Reported Device Performance

Study Details

Indications for Use

Device Name

Indications for Use (Describe)

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Section 5 - 510(k) Summary

Owner's Name Teco Diagnostics

Address and Contact Information:

Contact:

Date Prepared:

G. Regulatory Information:

H. Intended Use:

I. Device Description:

J. Substantial Equivalence Information:

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiagnostics.com

K. Test Principle:

L. Clinical Performance Characteristics:

M. Non-clinical studies:

N. Conclusion:

§ 862.1510 Nitrite (nonquantitative) test system.

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