URITEST 10 Urinalysis Reagent Strips provide qualitative and sem-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.

ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of use in screening at-risk patients to assist diagnosis in the following areas:

Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Device Description

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative for pH, specific gravity, ketones. blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Bayer® Family of Clinitek Urine Analyzers. The results are available within 120 seconds. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

AI/ML Overview

The provided text describes the URITEST 10 Urinalysis Reagent Strips but lacks specific details regarding acceptance criteria and the comprehensive study methodologies typically found in a full submission. However, based on the available information, I can construct a response.

Acceptance Criteria and Device Performance Study

The document states that the performance of URITEST 10 Urinalysis Reagent Strips was compared to the legally marketed predicate device, Bayer MULTISTIX 10 SG Reagent Strips. The overarching acceptance criterion appears to be "performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips."

Since specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not provided, I will infer that the reported performance implies a demonstration of equivalence or non-inferiority to the predicate device in terms of qualitative and semi-quantitative results for all ten analytes.

1. Table of Acceptance Criteria and Reported Device Performance

Analyte	Acceptance Criteria (Implied)	Reported Device Performance
pH	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	"URITEST 10 Urinalysis Reagent Strips provide 10 reagent tests of urinalysis that are similar in composition and performance to reagent tests currently provided by devices on the U.S. market." "ARJ Medical studies showed that URITEST 10 Urinalysis Reagent Strips provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC, hospital, and clinical settings."
Specific Gravity	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Ketones	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Blood	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Protein	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Nitrite	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Leukocytes	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Glucose	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Bilirubin	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)
Urobilinogen	Comparable results to Bayer MULTISTIX 10 SG Reagent Strips	(Same as above)

2. Sample Size for Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the test set used in the clinical performance study. It only mentions "a clinical laboratory setting" for the study.
Data Provenance: The data provenance is not explicitly stated in terms of country of origin. The study was conducted in a "clinical laboratory setting" and involved professional users in "centralized and point-of-care (POC) hospital clinical and doctor's office setting." It's reasonable to infer these settings are within the United States, given the FDA 510(k) submission. The study was prospective in nature as it involved collecting and testing urine samples using the URITEST 10 strips and comparing them to results from the predicate device.

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

The document does not state the number of experts or their specific qualifications for establishing ground truth for the test set. Instead, the "ground truth" for comparison was established by the results obtained from the Bayer MULTISTIX 10 SG reagent strips, which served as the reference standard in this equivalence study. The tests were read both visually and instrumentally by "professional users" (medical technologists).

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was derived from the predicate device's results, with the URITEST 10 results being compared to them.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not conducted. This device is a traditional urinalysis reagent strip, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation in that context. The study did involve both visual and instrumental readings by professional users, but this is a standard practice for this type of device, not an AI assistance evaluation.

6. Standalone Performance Study (Algorithm Only)

The concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable here. The device is a physical reagent strip that requires either visual interpretation by a human or instrumental reading (on Bayer Clinitek Urine Analyzers). It is not an algorithm that operates independently.

7. Type of Ground Truth Used

The type of ground truth used was comparative performance against a legally marketed predicate device (Bayer MULTISTIX 10 SG Reagent Strips). This is a common approach for 510(k) submissions demonstrating substantial equivalence. The predicate device's results, obtained through standard laboratory methods and visual/instrumental readings by professionals, served as the reference.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of device development. This terminology is typically associated with machine learning or AI algorithms, which are not described as part of this device's development or operation. The URITEST 10 is a chemical reagent-based test strip.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for an algorithm, the question of how its ground truth was established is not applicable to this 510(k) summary.

Summary

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URITEST 10 510(K) Summary

K052719

Prepared:	November 1, 2006
Submitter:	ARJ Medical, Inc
Address:	209 State StreetOldsmar, FL 34677	DEC - 5 2006
Contact Person:	Aaron BeharARJ Medical, Inc209 State StreetOldsmar, FL 34677Tel: (813) 855-1557Fax: (813) 854-2340
Trade Proprietary Name:	URITEST 10 Urinalysis Reagent Strips
Common/Usual Name:	Urinalysis Test Strips

Classification Names:

Urinary glucose (non-quantitative) test system (21 CFR 862.1340) - Class 11 Urinary bilirubin and its conjugates (non-quantitative) test system (21 CFR 862.1115) - Class I Ketones (non-quantitative) test system (21 CFR 862.1435) - Class I Specific Gravity test (not classified in 21 CFR 862 or 864) - proposed Class I Occult blood test (21 CFR 864.6550) - Class II Urinary pH (non-quantitative) test system (21 CFR 862.1550) - Class I Urinary protein or albumin (non-quantitative) test system (21 CFR 862.1645) -Class I Urinary urobilinogen (non-quantitative) test system (21 CFR 862.1785) - Class I Nitrite (non-quantitative) test system (21 CFR 862.1510) - Class I Leukocyte peroxidase test (21 CFR 864.7675) - Class I

Legally marketed devices which we are claiming equivalence:

Bayer Corporation MULTISTIX 10 SG Reagent Strips

Device Description:

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Intended Use:

ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (pointof-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. .

Assessment of Performance:

The performance of URITEST 10 Urinalysis Reagent Strips was studied in a clinical laboratory setting. The strips were read visually and instrumentally using the Family of Bayer Clinitek Urine Analyzers. The results were compared to results obtained from Bayer MULTISTIX 10 SG reagent strips. The studies demonstrated that professional users in centralized and point-of-care (POC) hospital . clinical and doctor's office setting can obtain valid urinalysis test results.

Conclusion:

URITEST 10 Urinalysis Reagent Strips provide 10 reagent tests of urinalysis that are similar in composition and performance to reagent tests currently provided by devices on the U.S. market. URITEST 10 Urinalysis Reagent Strips are suitable for use in point-of-care (POC) settings. ARJ Medical studies showed that URITEST 10 Urinalysis Reagent Strips provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC, hospital, and clinical settings.

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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 caduceus, which is a symbol of medicine, with three wavy lines representing the three branches of government. The logo is surrounded by the words "U.S. Department of Health & Human Services" in a circular pattern.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Aaron Behar ARJ Medical, Inc. 209 State Street Oldsmar, FL 34677

DEC - 5 2006

Re: K052719

Trade/Device Name: URITEST 10 Urinalysis Reagent Strips Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: JIO, JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN Dated: November 1, 2006 Received: November 3, 2006

Dear Mr. Behar:

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) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, Ph.D. 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: (Applied For)

Device Name: URITEST 10 Urinalysis Reagent Strips

Indications for Use:

Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Prescription Use __ X___ AND/OR Over-The-Counter Use _____________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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 Benem

Office of In Vitro Diagnostic Device Evaluation and Safety

K052719

Regulation Number and Section

§ 862.1785 Urinary urobilinogen (nonquantitative) test system.

(a)
Identification. A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.(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.