The ACON UTI Urinary Tract Infection Test Strips is for the qualitative detection of Leukocyte and Nitrite in urine as an aid in the screening of urinary tract infection (UTI). It is intended for over-the-counter home use only.

Device Description

The ACON UTI Urinary Tract Infection Test Strips for Leukocytes and Nitrite are urine test strips of which Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for over-the-counter home use with human urine.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text for the ACON UTI Urinary Tract Infection Test Strips:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics (e.g., sensitivity, specificity, accuracy percentages) for the ACON UTI Urinary Tract Infection Test Strips. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device.

The "reported device performance" is broadly stated as:

"The performance characteristics of the ACON UTI Urinary Tract Infection Test Strips were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, read time flex study, and stability studies."
"Testing results indicate that the ACON UTI Urinary Tract Infection Test Strips are robust and can perform satisfactorily when used according to the 'Directions for Use' statement specified in the package insert."
"The laboratory testing results and clinical studies demonstrated a substantial equivalency on performance between the ACON UTI Urinary Tract Infection Test Strips and a legally marketed product, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396), with similar product features and intended use."

Since specific numerical acceptance criteria are not provided, a table with quantitative metrics cannot be fully constructed. The primary "acceptance" was demonstrating substantial equivalence to the predicate device.

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

Sample Size: The document does not specify the exact sample size (number of patients or urine samples) used for the clinical tests. It only states "clinical studies were conducted at Beta sites."
Data Provenance: The data was collected from "Beta sites," indicating real-world clinical settings. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, and the submitter is based in San Diego, California, suggesting the studies were likely conducted in the USA (or at least within a regulatory framework acceptable to the FDA for a US market device). The studies were retrospective or prospective is not specified and cannot be determined from the provided text.

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

The document states that "inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals." This implies that "professionals" were involved in establishing a comparative benchmark.
Number of Experts: Not specified.
Qualifications of Experts: The experts are referred to as "professionals," but their specific qualifications (e.g., "radiologist with 10 years of experience" or medical technologists, lab technicians) are not detailed.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly described. The comparison involved "inexperienced lay users" versus "professionals" (presumably interpreting the test strips as well), but the process for resolving disagreements or establishing a definitive ground truth from these interpretations is not detailed.

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

No. This device is a manual urine test strip for home use, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving 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

No. This device is a test strip that requires human visual interpretation. It is not an algorithm, and it does not operate in a standalone-algorithm-only manner.

7. The Type of Ground Truth Used

The ground truth for the comparison was established by "professionals" using the "legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396)." This implies a comparative ground truth against an established, legally marketed predicate device, rather than an independent gold standard like pathology or advanced imaging, given the nature of the test. For a UTI test strip, the "professional" interpretation of the predicate device's results would serve as the reference.

8. The Sample Size for the Training Set

This information is not provided. The document discusses "clinical studies" and "laboratory testing results" but does not differentiate between "training" and "test" sets in the context of machine learning. As this is not an AI/ML device, a traditional "training set" as understood in that domain is likely not applicable. The "sensitivity study, reproducibility study, interference studies, temperature flex study, read time flex study, and stability studies" would involve various samples used for product development and validation, but these are not explicitly termed "training set."

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

As a traditional diagnostic device (not AI/ML), the concept of a "training set" with ground truth in the AI sense is not directly applicable. If one considers the development and validation efforts as "training," then the establishment of ground truth for these internal studies would involve standard laboratory methods, reference materials, and controlled experimental conditions to determine the expected reactions and establish performance characteristics. However, these specific methods are not detailed in the provided summary.

Summary

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5. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.

The Assigned 510(k) number is K063295

Submitter's Identification:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: 858-875-8000 Fax: 858-875-8099

Date Prepared: October 31, 2006

Contact Person:

Jinn-nan Lin, Ph.D. V.P., Regulatory Affairs

Proprietary Name of the Device:

ACON UTI Urinary Tract Infection Test Strips

Common Name:

Urinary Tract Infection Test Strips

Regulation Section and Classification:

21 CFR § 862.1510 Nitrite (Non-Quantitative) Test System 21 CFR § 864.7675 Leukocyte Peroxidase Test

Class I: Urinary Leukocytes, Nitrite

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Product Code:

LJX Test. Urine Leukocyte Nitrite (urinary, non-quant.) test system JMT

Medical Specialty:

Clinical Chemistry

Predicate Device:

Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA.

Device Description:

Intended Use:

Tests Principles:

Nitrite: This test depends upon the conversion of nitrate to nitrite by the action of Gram negative bacteria in the urine. In an acidic medium, nitrite in the urine reacts with p-arsanilic acid to form a diazonium compound. The diazonium compound in turn couples with 1 N-(1naphthyl)-ethylenediamine to produce a pink color. Nitrite is not detectable in normal urine. The nitrite area will be positive in some cases of infection, depending on how long the urine specimens were retained in the bladder prior to collection. Retrieval of positive cases with the nitrite test ranges from as low as 40% in cases where little bladder incubation occurred, to as high as approximately 80% in cases where bladder incubation took place for at least 4 hours.

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Leukocytes: This test reveals the presence of granulocyte esterases. The esterases cleave a derivatized pyrazole amino acid ester to liberate derivatized hydroxy pyrazole. This pyrazole then reacts with a diazonium salt to produce a beige-pink to purple color. Normal urine specimens generally yield negative results. Trace results may be of questionable clinical significance. When trace results occur, it is recommended to retest using a fresh specimen from the same patient.

Substantial Equivalence:

The ACON UTI Urinary Tract Infection Test Strips for Leukocytes and Nitrite are substantially equivalent to the Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).

Characteristic of the ACON UTI Urinary Tract Infection Test Strips are compared with the Bayer Multistix 10 SG system (K905396) in the following table:

Area of Comparison	ACON UTI Urinary Tract InfectionTest Strips	Bayer Multistix 10 SG ReagentStrips for Urinalysis (K905396)
Intended Use	For qualitative detection of Leukocyteand Nitrite in urine as an aid in thescreening of urinary tract infection(UTI)	For qualitative detection ofLeukocyte and Nitrite in urine as anaid in the screening of urinary tractinfection (UTI)
Target Population	Lay persons for over-the-counterhome use only	Patients of physicians, hospitals,and clinicsFor professional use in point-of-care urine testing
Intended Specimen	Urine	Same
Material Provided	Plastic strips affixed with severalseparate reagent areas.	Same
Storage	2 to 30°C	15 to 30°C
Test Time	Varies from 60 Seconds to 2 Minutes .	Same
Nitrite Methodology	This test depends upon the conversionof nitrate to nitrite by the action ofGram negative bacteria in the urine. Inan acidic medium, nitrite in the urinereacts with p-arsanilic acid to form adiazonium compound. The diazoniumcompound in turn couples with 1 N-(1-naphthyl)-ethylenediamine to producea pink color.	Same
LeukocyteMethodology	This test reveals the presence ofgranulocyte esterases. The esterasescleave a derivatized pyrazole aminoacid ester to liberate derivatizedhydroxy pyrazole. This pyrazole thenreacts with a diazonium salt toproduce a beige-pink to purple color.	Same

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Discussion of Clinical Tests Performed:

The clinical studies were conducted at Beta sites using the ACON UTI Urinary Tract Infection Test Strips (Section 20, page 43 of this submission). Clinical data were presented evaluating clinical accuracy of results. Clinical study results indicate that the inexperienced lay users were able to obtain comparable testing data compared to those obtained by the professionals when using the ACON UTI Urinary Tract Infection Test Strips and the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396).

Conclusion:

The performance characteristics of the ACON UTI Urinary Tract Infection Test Strips were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, read time flex study, and stability studies. Testing results indicate that the ACON UTI Urinary Tract Infection Test Strips are robust and can perform satisfactorily when used according to the "Directions for Use" statement specified in the package insert.

The laboratory testing results and clinical studies demonstrated a substantial equivalency on performance between the ACON UTI Urinary Tract Infection Test Strips and a legally marketed product, Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396), with similar product features and intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT I 2 2007

ACON Laboratories, Inc. c/o Dr. Jinn-nan Lin 4108 Sorrento Valley Boulevard San Diego, CA 92121

Re: K063295

Trade/Device Name: ACON UTI Urinary Tract Infection Test Strips Regulation Number: 21 CFR 862. 1510 Regulation Name: Nitrite (nonquantitative) test system Regulatory Class: Class I (meets the limitations of exemption in 21 CFR 862.9) Product Code: LJX, JMT Dated: September 18, 2007 Received: September 19, 2007

Dear Dr. Lin:

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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., 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 4.

510(k) Number (if known):

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K063295

ACONTM UTI Urinary Tract Infection Test Strips Device Name:

Indications for Use:

The ACON UTI Urinary Tract Infection Test Strips are for the qualitative detection of Nitrite and Leukocytes in urine as an aid in the screening of urinary tract infection (UTT). It is intended for over-the-counter home use only.

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

Over-The-Counter Use _ X (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

Vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K063295

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 864.7675 Leukocyte peroxidase test.

(a)
Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.