UriDynamics StoneGuard™ II Test Strips are intended for semiquantitative measurement of pH and specific gravity in fresh urine. They can be used to monitor conditions that may cause the formation of kidney stones, namely trends in urinary pH and hydration status.

Confirm Low™ and Confirm High™ Control Solutions are intended for in vitro (external) use only, for use as control materials for StoneGuard™ II Test Strips only.

Device Description

UriDynamics StoneGuard™ II Test Strips consist of plastic carriers with two reagent pads attached. The pads respond to pH and specific gravity. StoneGuard™ II Test Strips are stored in an opaque vial with desiccant and are ready to use. Results may be read between 30 and 60 seconds after wetting with a freshly-voided urine sample. Results are obtained by comparing the color developed on the pads with a printed color chart. The results are semi-quantitative. Control solutions, Confirm Low™ and Confirm High™, intended for use with StoneGuard™ II Test Strips, are also included in this submission. Confirm Low™ and Confirm High™ contain buffers and salts that give a known response with StoneGuard™ II Test Strips. Confirm Low™ and Confirm High™ Control Solutions are ready to use in dispensers, and contain no biological ingredients.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Accuracy" and "Correlation of Consumer & Reference Results" sections. The reported performance refers to the results obtained in the studies.

Acceptance Criteria (Implied)	Reported Device Performance (StoneGuard™ II)
pH Accuracy	100% of results within one-half color block of the expected value.
pH Correlation (Consumer)	92.5% of participant results within ± one-half pH unit of the reference value.
Specific Gravity Accuracy	At least 75% of results within one-half color block of the expected value.
Specific Gravity Correlation (Consumer)	92.5% of participant results within ±0.010 of the reference.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 107 participants for the clinical studies.
Data Provenance: The study was conducted at four sites in Indiana, USA. The data is prospective, as it involved recruiting participants for a "Clinical Studies" section, indicating data collected specifically for the purpose of this evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. Instead, it refers to "reference results obtained by refractometer for specific gravity and pH meter for pH" (for specificity, Corning Model 313 pH Meter and eclipse Handheld Refractometer). This suggests that established laboratory instruments served as the "ground truth" rather than human experts.

4. Adjudication Method for the Test Set

The document does not describe any human adjudication method (e.g., 2+1, 3+1). The ground truth was established by laboratory instruments.

5. 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

There was no MRMC comparative effectiveness study involving AI mentioned in the document. This device is a visual reagent test strip, not an AI-powered diagnostic. The study focused on assessing untrained consumers' ability to interpret results visually compared to reference instruments.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable, as StoneGuard™ II is a visual test strip requiring human interpretation, not an algorithm. The "standalone" performance here refers to the performance of the chemical pads themselves responding to pH and specific gravity, which was tested for accuracy and precision against reference instruments.

7. The Type of Ground Truth Used

The ground truth used was instrument-based reference values.

For pH: Readings from a Corning Model 313 pH Meter.
For specific gravity: Readings from an eclipse Handheld Refractometer.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or algorithm development, as this is a chemical reagent strip. The studies described are for validation of the final product.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of this device. The "ground truth" for the performance evaluation was established by laboratory instruments as described in point 7.

Summary

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K030650

Helping You Take Care of Yourself

6786 Hawthorne Park Drive Indianapolis, IN 46220

510[k] Summary

APR 1 4 2003

Submitted by:

UriDynamics, Inc., 6786 Hawthorne Park Drive, Indianapolis, IN. 46220 Phone/Fax (317) 915-7896

Contact Person: Myron Rapkin Date Prepared: 2/19/03

Device Name:

Common Name: Visual Reagent Test Strip for Urine pH & Specific Gravity Trade Name: StoneGuard™ II

Predicate Devices:

pH: Corning Model 313 pH Meter with 3-in-1 Combination Gel-Filled Electrode (Corning) Specific gravity: eclipse Handheld Refractometer (Bellingham & Stanley)

Description:

Intended Use:

StoneGuard™ II Test Strips are for the semi-quantitative estimation of urine pH and specific gravity. StoneGuard™ II Test Strips are intended for use by consumers to monitor urine pH and specific gravity in freshly-voided urine samples to aid in the prevention of kidney stone formation. Readings are made by visual comparison with a color chart.

Confirm Low™ and Confirm High™ Control Solutions are provided to monitor performance of the test strips and to provide quality control for the users.

Substantial Equivalence:

The rationale for substantial equivalence was a comparison between results obtained by untrained participants and reference results obtained by refractometer for specific gravity and pH meter for pH.

Laboratory Studies

Medication Studies: These data demonstrate that commonly-used analgesics and nutritional supplements do not affect the reading of StoneGuard™ II Test Strips.

Blood Interference Studies: Even at the highest levels tested, there was no change in the appearance of the reacted test strips. The presence of blood in urine did not affect the user's ability to interpret the color blocks correctly.

Sensitivity of the Specific Gravity Test: The sensitivity of the specific gravity test was less than one-half color.

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Uriliynamics Inc.

6786 Hawthorne Park Drive Indianapolis, IN 46220

Qualification of pH 7.5 Color Block: Color space measurements demonstrate good resolution of pH in the clinically sensitive range of 6.5 to 8.0.

Qualification of 30-60 Second Read Time: Color space readings and timed demonstrated that there was no significant change in readings done between 30 and 60 seconds

Effect of Illumination Type on Test Results: Results demonstrate that results with StoneGuard™ II Test Strips are not affected significantly by changes in illumination.

Accuracy of StoneGuard™ II Test Strip pH & Specific Gravity; At every specific gravity, at least 75% of results were within one-half color block of the expected value. At every pH value, 100% of results were within one-half color block of the expected value. At least 70% of all results agreed with the expected value.

Precision of StoneGuard™ II Test Strip pH & Specific Gravity: At every specific gravity, 100% of results agreed with the expected values. At every pH value, 95% of results agreed with the expected value.

Clinical Studies

Participants: A total of 107 participants were recruited for the study at four sites in Indiana.

Readability Study: With the exception of unavoidable technical language, the package inserts fall within the recommended ranges. The critical, basic directions portion exceeds the recommendation.

Correlation of Consumer & Reference Results: For specific gravity, 92,5% of participant results were within ±0.010 of the reference. For pH, 92.5% of participant results were within ± onehalf pH unit of the reference value.

Precision of Repeated Reading: For each test pad, 21 of 22 participants gave identical readings for all four replicate readings.

Precision & Accuracy Using Confirm™ Solutions: Results demonstrate excellent accuracy and precision of the results with Confirm™ Control Solutions.

Survey Response Summary: Most participants found the directions easy to understand and found the test easy to perform. Furthermore, the majority of participants found it easy to match the developed color to the color chart.

pH Interference in the Specific Gravity Test: Analysis demonstrated that specific gravity for StoneGuard™ II Test Strips is low by almost one color block at urine pH 7.5. This is within the effect known for pH error.

Discussion and Conclusions

StoneGuard™ II Test Strips constitutes a robust device for home monitoring of urine pH and specific gravity. Consumer convenience features include:

30-second read window .
Confirm Low ™ and Confirm High™ Control Solutions with a wide range of known values .
. No significant color change under different types of illumination
No interference from common medications and nutritional supplements .
No interference from blood, even at high levels .

Based on the results of laboratory and clinical studies, we conclude that StoneGuard™ II Test Strips are substantially equivalent to the legally marketed DiaScreen Reagent Strips for Urinalysis (K961374 &K 971976) as well as the Bellingham & Stanley eclipse Handheld Refractometer for specific gravity and the Corning Model 313 pH Meter.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three lines extending upwards from the head, representing growth and development. The words "HUMAN SERVICES - USA" are arranged in a circular pattern above the figure, and the word "DEPARTMENT" is placed below the figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 4 2003

Mr. Myron Rapkin President UriDynamics, Inc. 6786 Hawthorn Park Drive Indianapolis, IN 46220

K030650 Re: Trade/Device Name: StoneGuard™ II Test Strips Regulation Number: 21 CFR 862.1550 Regulation Name: Urinary pH (nonquantitative) test system Regulatory Class: Class I Product Code: CEN: JRE: JJW Dated: February 19, 2003 Received: February 28, 2003

Dear Mr. Rapkin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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1.4 Indications for Use

February 19, 2003

Premarket Notification (510(k)) Number:

DEVICE NAME: StoneGuard™ II Test Strips

INDICATIONS FOR USE

Confirm Low™ and Confirm High™ Control Solutions are intended for in vitro (external) use only, for use as control materials for StoneGuard™ II Test Strips only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use _

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Jean Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K030650

Page 13

2/19/03

Regulation Number and Section

§ 862.1550 Urinary pH (nonquantitative) test system.

(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(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.