URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening in the following areas:

Kidney function
Urinary tract infections
Carbohydrate metabolism (e.g. diabetes mellitus)
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

URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semiquantitative tests for ascorbic acid, pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin and urobilinogen in urine. URISTIK H Series Reagent Strips For Urinalysis 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 Dirui H-50, H-100, or H-500 Urine Analyzer. The results are available within one minute. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

AI/ML Overview

The provided text describes the regulatory filing for the URISTIK H Series Reagent Strips but lacks specific quantitative acceptance criteria or detailed study results with exact performance metrics. However, it does provide a summary of the studies conducted and the conclusions reached regarding performance.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) are not explicitly stated in the provided document. Similarly, detailed quantitative performance data (like exact percentages of agreement or accuracy values) are not reported.

The document broadly states:

"The studies demonstrated that professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings can obtain valid urinalysis test results."
"Dirui studies showed that the URISTIK H Series Reagent Strips For Urinalysis provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC settings."

Therefore, a table with specific acceptance criteria and reported performance cannot be fully constructed from the given text.

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

Sample Size: Not specified. The document only mentions "clinical laboratory settings."
Data Provenance: The studies were conducted in "clinical laboratory settings by professional users." The product's manufacturer is Changchun Dirui Industrial Co., Ltd. (China), but the specific locations (e.g., countries) where these clinical studies were performed are not detailed. It is not explicitly stated whether the data was retrospective or prospective, but clinical laboratory studies often imply prospective collection.

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

Number of Experts: Not specified.
Qualifications: "Professional users" performed the tests and comparisons. Implicitly, these would be laboratory professionals or clinicians, but specific qualifications (e.g., "clinical pathologist with 5 years of experience") are not provided.

4. Adjudication Method for the Test Set

The document states that "The results were compared to results obtained from Bayer MULTISTIX 10 SG Reagent Strips and from laboratory test methods." This implies a comparison against established methods. However, the specific adjudication method (e.g., whether multiple experts reviewed discrepant results, or if there was a predefined algorithm for determining a 'true' result) is not described.

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

It is not explicitly stated that an MRMC comparative effectiveness study was done regarding human readers improving with or without AI assistance. The device is a reagent strip for urinalysis, which is typically read visually or by a dedicated analyzer; it's not an AI-assisted diagnostic imaging device for human interpretation. The study focused on the performance of the strips when read visually by professional users versus instrumentally, and in comparison to predicate devices and laboratory methods.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, performance was assessed both visually (implying human-in-the-loop) and "instrumentally using Dirui H Series Urine Analyzers." The instrumental reading can be considered a form of standalone performance for the combined strip-analyzer system, independent of visual human interpretation. However, the exact performance metrics for the instrumental reading versus visual reading are not provided.

7. Type of Ground Truth Used

The ground truth was established by "laboratory test methods." These "laboratory test methods" are implied to be established, more definitive reference methods for the urinalysis parameters being assessed (e.g., chemical assays for glucose, microscopic examination for blood cells).

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is typical for reagent strip validation, which often focuses on clinical performance rather than machine-learning model training.

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

As no training set is mentioned, the method for establishing its ground truth is also not described.

Summary

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K040703

AUG 2 6 2004

Image /page/0/Picture/2 description: The image contains the logo and contact information for "Changchun Dirui Industrial Co., Ltd." The address is "95, Yunhe St., New& High Tech. Development Zone, Changchun, 130012, China." The telephone number is (86 431) 5100409, and the fax number is (86 431) 5173354. The email address is dr@public.cc.jl.cn, and the website is http://www.dirui.com.cn.

510(k) Summary

February 13, 2004 Prepared:

Dirui Industrial Co. Ltd. Submitter:

Address: 95 Yunhe Street New & High Technology Development Zone Changchun, 130012, China

Contact Person (U.S. Agent):

Joseph F. Ludford U.S. Conformity Consultants, Inc. 7560 Lindbergh Drive Gaithersburg, MD 20879 Tel: 301-417-0220 Fax: 301-417-9069

Trade/Proprietary Name:

URISTIK H Series Reagent Strips For Urinalysis

Common/Usual Name:

Urinalysis Test Strips

Classification Names:

Occult blood test (21 CFR 864.6550) - Class II Urinary glucose (nonquantitative) test system (21 CFR 862.1340) - Class II Urinary urobilinogen (nonquantitative) test system (21 CFR 862.1785) - Class I Urinary bilirubin and its conjugates (nonquantitative) test system (21 CFR 862.1115) - Class I Ketones (nonquantitative) test system (21 CFR 862.1435) - Class I Urinary protein or albumin (nonquantitative) test system (21 CFR 862.1645) - Class I Nitrite (nonquantitative) test system (21 CFR 862.1510) - Class I Leukocyte peroxidase test (21 CFR 864.7675) - Class I Urinary pH (nonquantitative) test system (21 CFR 862.1550) - Class I Ascorbic acid test system (21 CFR 862.1095) - Class I Specific gravity test (not classified in 21 CFR 862 or 864) - proposed Class I

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Image /page/1/Picture/0 description: The image shows the logo and contact information for DIRUI Industrial Co., Ltd. The address is 95 Yunhe St., New & High Tech. Development Zone, Changchun, 130012, China. The telephone number is (86431) 5100409, and the fax number is (86431) 5173354. The email address is dr@public.cc.jl.cn, and the website is http://www.dirui.com.cn.

Note: Occult blood test and urinary glucose test are the subject of this submission.

Legally marketed devices to which we are claiming equivalence:

Bayer Corporation MULTISTIX 10 SG Reagent Strips (K-file not identified) Behring Diagnostics RAPIGNOST TOTAL SCREEN L Urine Test Strips (K861255) Boehringer Mannheim CHEMSTRIP 10 with SG Urine Test Strips (K896454) International Newtech Development Urinalysis Reagent Strips (10 Parameters) (K993850)

Device Description:

Intended Use:

URISTIK H Series Reagent Strips For Urinalysis are for professional use in pointof-care (POC) testing such as in hospitals, clinics, and clinical laboratories. The reagent strips are intended for use to assist diagnosis of the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.

Technological Characteristics:

URISTIK H Series Reagent Strips For Urinalysis include reagent areas for assessing the presence of occult blood and urine glucose. A high concentration of ascorbic acid will effect the test for glucose. Ascorbic acid is reported from 0.6 to 5.0 mmol/L. A glucose reagent is used that measures glucose levels from 5.5 to 55 mmol/L. A blood reagent is used that measures occult blood levels from 10 to 200cells/ µ L.

The test for glucose is based on the glucose-specific glucose oxidase/peroxidase method. Oxidation of glucose forms hydrogen peroxide, which in turn oxidizes a chromogen in the peroxidase reaction to generate green or blue color. The test for blood is based on the peroxidase activity of hemoglobin and myoglobin creating a green color with oxidation of a chromogen. Intact erythrocytes which hemolyze on the test paper will produce a green dot.

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Image /page/2/Picture/0 description: The image shows the logo and contact information for Changchun Dirui Industrial Co., Ltd. The logo consists of the company name in Chinese characters and the English name "DIRUI" in a stylized font. The contact information includes the company's address at 95 Yunhe St., New & High Tech Development Zone, Changchun, 130012, China, as well as phone numbers (86 431) 5100409 and (86431) 5173354, and email address dr@public.cc.jl.cn and website http://www.dirui.com.cn.

Assessment of Performance:

The performance of URISTIK H Series Reagent Strips For Urinalysis was studied in clinical laboratory settings by professional users. The strips were read visually and instrumentally using Dirui H Series Urine Analyzers. The results were compared to results obtained from Bayer MULTISTIX 10 SG Reagent Strips and from laboratory test methods. The studies demonstrated that professional users in centralized and point-of-care (POC) hospital, clinic, and doctor's office settings can obtain valid urinalysis test results.

Conclusion:

URISTIK H Series Reagent Strips For Urinalysis provide 11 reagent tests for urinalysis that are similar in composition and performance to reagent tests currently provided by devices on the U.S. market. URISTIK H Series Reagent Strips For Urinalysis are suitable for use in point-of-care (POC) settings. Dirui studies showed that the URISTIK H Series Reagent Strips For Urinalysis provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC settings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The eagle is depicted in a simple, abstract style, with thick lines forming its body and wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 6 2004

Dirui Industrial Co., Ltd. c/o Mr. Joseph F. Ludford President U.S. Conformity Consultants, Inc. 7560 Lindbergh Drive Gaithersburg, MD 20879

K040703 Re:

Trade/Device Name: URISTIK H Series Reagent Strips Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Regulatory Class: Class: Class ::
Product Code: JIO, JIL, KQO, JRE, JMA, CEN, LJX, JMT, JIR, JIN, JJQ, CDM Dated: August 6, 2004 Received: August 23, 2004

Dear Mr. Ludford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). and coomete / for ( 10 ) lear the device, subject to the general controls provisions of the Act. The r ou may, disrerere, mains of the Act include requirements for annual registration, listing of general controls profice, 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 it may 60 but 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 I'DA's issuance of a substantial equivalence determination does not mean r icase of advisou that I Drivisanthat your device complies with other requirements of the Act that I Dri has intate a word regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 comply with and the ring (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) I his letter will anow you to ough maing of substantial equivalence of your device to a legally prematication. The Pice 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, If you destions on the promotion and advertising of your device, please contact the Office of of questions on the presise Evaluation and Safety at (301) 594-3084. Also, please note the In v are Diagnostic Dollywooding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may obtain 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.

Jean 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: K040703

Device Name: URISTIK H Series Reagent Strips

Indications For Use:

URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for URISTIK H Senes Reagent Omps provide quotitions (acetoacetic acid), blood, protein, nitrite, ascorbic acid, pri, Specific gravity, Rotollios (es in urine. Tiest results may provide leukocytes, glucose, billiudin, and uroblikhogen in annel of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Dirui H Series Reagent Strips are for single use in professional near-patient (point-of-Dirul H Series Reagent Stips are for Single as in professor.
care) and centralized laboratory locations. The strips are intended for use in screening care) and contrail200 is the following areas:

Kidney function .
Urinary tract infections .
Carbohydrate metabolism (e.g. diabetes mellitus) .
Liver function .
Acid-base balance .
Urine concentration .

Test results can be used along with other diagnostic information to rule out certain Test results can be doba along the mornscopic analysis is needed.

x 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) Caroll Seman Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1 _

510(k) K040703

Regulation Number and Section

§ 864.6550 Occult blood test.

(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.