DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucose in urine. These measurements are used in the screening and diagnosis of glucose metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of ketones in urine. Identification of ketones is used in the qualitative measurement of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes.

Testing can be done by dipping the Reagent Strips into a specimen container or by holding them directly in the urine stream.

The glucose and ketone strips are intended for both professional and over-the-counter use.

Device Description

DiaScreen® Reagent Strips for Urinalysis are plastic strips coated with one or more dry reagents. Each reagent is specific for a particular analyte. Reagent areas are spaced along the test strip, with a physical gap between reagent areas. Three configurations are designed for both professional and home use: detecting one or both of the following analytes: glucose, ketone. The dry reagents change color in reaction to the presence, and concentration, of their associated analyte. The strips are read visually against a color chart.

AI/ML Overview

The provided 510(k) summary for the DiaScreen® Reagent Strips for Urinalysis does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative data to definitively prove the device meets those criteria.

However, based on the available text, we can infer some aspects and highlight what is missing.

Here's an attempt to answer your questions based on the provided text, along with notes about information that is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria (Inferred/Not Stated)	Reported Device Performance	Notes/Missing Information
Accuracy (Home Use)	Not explicitly stated (e.g., specific sensitivity/specificity thresholds)	"home users can obtain accuracy which is substantially equivalent to that obtained by professional users."	This is a qualitative statement of equivalence. No numerical accuracy metrics (e.g., percent agreement, sensitivity, specificity, PPV, NPV) are provided for either home users or professional users, nor are the specific acceptance thresholds for these metrics.
Precision/Reproducibility	Not explicitly stated	Not reported	No data on the variability of results within or between users, or over time.
Interfering Substances	Not explicitly stated	Not reported	No information on potential interferences from common urine components, medications, or other substances that might affect test results.
Stability (Shelf-life)	Not explicitly stated	Not reported	No data on the stability of the reagent strips over their shelf-life under various storage conditions.
Readability of Color Chart	Not explicitly stated (e.g., clear distinction between color blocks)	Implied to be sufficient for visual reading.	No specific validation of the color chart's clarity or ease of interpretation for untrained users.
Equivalence to Predicate Device	Substantial equivalence to the existing "DiaScreen® Reagent Strips for Urinalysis"	Implied by the FDA's 510(k) clearance: "device is substantially equivalent"	While the FDA has determined substantial equivalence, the specific performance metrics used to support this for the new labeling for OTC use are not detailed here. The primary claim for this submission seems to be the change in intended use/labeling to include OTC home use.

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

Sample Size: Not specified. The document only mentions "Clinical data" and "Testing demonstrated," but provides no numbers for participants or urine samples for any clinical study.
Data Provenance: Not specified (e.g., country of origin). The study is simply referred to as "Clinical testing." It is implied to be prospective, as it involves home users obtaining results, likely comparing them to professional users.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document refers to "professional users," implying healthcare professionals, but their specific titles, years of experience, or training for interpreting these strips are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. It is unclear how discrepancies between home user results and professional user results (or any other ground truth) were resolved, or if any formal adjudication process was used.

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

MRMC Study: No. This device is a visual dipstick test, not an AI-powered diagnostic imaging or interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

Standalone Performance: Not applicable. This is a manual, visually interpreted test strip. There is no "algorithm only" performance to evaluate. The performance is inherently tied to human visual interpretation.

7. The Type of Ground Truth Used

Type of Ground Truth: The document implies that the ground truth for home user performance was based on the results obtained by "professional users." This suggests a comparison to a referent standard performed by trained personnel, likely using the same DiaScreen® Reagent Strips or a laboratory reference method. However, the exact nature of this "ground truth" (e.g., whether professional user results were cross-referenced with a lab analyzer, pathology, or confirmed clinical outcomes) is not specified.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance relies on the inherent chemical reactions on the strip and visual interpretation against a color chart.

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

Training Set Ground Truth: Not applicable, as there is no training set for this type of device.

Summary

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MAR - 2 2004

510(k) Summary

	1. SUBMITTED BY:	Bruce A. MacFarlane, Ph.D.5182 West 76th StreetEdina, MN 55439USASummary prepared: 26 November 2003
	2. NAME OF DEVICES:
	Trade Name:	DiaScreen® Reagent Strips for Urinalysis
	Common Names/Descriptions:	Urine Test Strips
	Classification Names:	Ketones (nonquantitative) test systemUrinary glucose (nonquantitative) test system
	Regulatory Status:	Class II
	3. PREDICATE DEVICE:	DiaScreen® Reagent Strips for Urinalysis

1. PREDICATE DEVICE:
1. DEVICE DESCRIPTION:

· glucose
ketone .

The dry reagents change color in reaction to the presence, and concentration, of their associated analyte. The strips are read visually against a color chart.

5. INTENDED USE:

DiaScreen® Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens. DiaScreen Reagent Strips provide gualitative and semiquantitative tests for ketone, and glucose by visual comparison to a color chart. The tests provided are considered routine urinalysis.

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6. Summary of TECHNOLOGICAL CHARACTERISTICS

DiaScreen® Reagent Strips for Urinalysis are plastic strips coated with one or more dry reagents. Each reagent is specific for a particular analyte. Reagent areas are spaced along the test strip, with a physical gap between reagent areas. Several product along the tool comp, man commercially available, detecting one or more of the following analytes: specific gravity, pH, blood, leukocytes, nitrite, protein, bilirubin, ketone (acetoacetic acid), glucose, and urobilinogen. The dry reagents change color in (acction to the presence, and concentration, of their associated analyte. The present premarket notification encompasses the ketone and glucose analytes only.

7. NON-CLINICAL TESTING

Not applicable.

8. CLINICAL TESTING

Clinical data indicate that home users can obtain accuracy which is substantially equivalent to that obtained by professional users.

9. CONCLUSIONS FROM TESTING

Testing demonstrated that performance of the test strips with new labeling is appropriate for Over-the-Counter home usage.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 2 2004

Bruce A. MacFarlane, Ph.D. VP, Regulatory Affairs And Quality Systems Hypoguard USA, Inc. 5182 West 76th Street Edina, MN 55439

Re: K033851

Trade/Device Name: Dia Screen® Reagent Strips for Urinalysis Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL; JIN Dated: November 26, 2003 Received: December 17, 2003

Dear Dr. MacFarlane:

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 conimer be prox & may 2011 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 r ou may) arores or your softhe 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, Codc 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I ederal 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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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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K033851

Device Name: DiaScreen® Reagent Strips for Urinalysis

Indications For Use:

DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-Diasoicon "Reagone Burgo 101 Original (glucose in urine). These measurements are qualitiative measurement of gracessaria (grace metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-Diantitative measurement of ketones in urine. Identification of ketones is used in qualifiative incasurement of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes.

Testing can be done by dipping the Reagent Strips into a specimen container or by holding them directly in the urine stream.

The glucose and ketone strips are intended for both professional and over-thecounter use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C Benson

Division Sign-Off

of In Vitro Dlag

Page 1 of 1

510(k)

Regulation Number and Section

§ 862.1340 Urinary glucose (nonquantitative) test system.

(a)
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.(b)
Classification. Class II.