The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acidbase balance and bacteriuria. The instruments use the accompanying check strip for daily calibration.

Untest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Untest 11G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Untest 11G urine reagent strips are for use with Untest-500B urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Device Description

The Uritest-50 and Uritest-500B Urine Analyzers are reflectance spectorphotometers that instrumentally measure the reflectance of a reacted Uritest 10G or Uritest 11G urine reagent strip for urinalysis. The Uritest-50 and Uritest-500B Urine Analyzers display and print urinalysis results and can be connected to a laboratory computer for data management.

AI/ML Overview

The provided text is a 510(k) summary for the Uritest-50 and Uritest-500B Urine Analyzers and accompanying reagent strips. It states that "Studies were conducted in-house and in clinical settings to demonstrate that the performance of the Uritest-50 and Uritest-500B Urine Analyzers and Uritest 10G or Uritest 11G urine reagent strips are equivalent to the predicate devices." and thus "demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use."

However, this document does not include any specific acceptance criteria or detailed results from the performance studies. It generally claims equivalence to predicate devices but does not provide data or methodology to support this claim in the given text.

Therefore, for most of your requested information, I cannot provide an answer based only on the provided text.

Here's what I can provide and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified in the provided text.
Reported Device Performance: Not detailed in the provided text. The document only makes a general statement about equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text.
Data Provenance: "in-house and in clinical settings." The country of origin is not explicitly stated for the clinical settings, but the submitter is in China. Whether it was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified or mentioned in the provided text. The nature of the ground truth (e.g., comparison to predicate devices, or a specific reference method) is implied to be relative to predicate devices, but the process of establishing ground truth for the test set based on expert input is not described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified or mentioned in the provided text.

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

This device is a urine analyzer and reagent strips, which performs semi-quantitative detection automatically. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or results with and without AI assistance. Therefore, an MRMC study in the context of human reader improvement with AI is not applicable to this type of device based on its description.

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

The device, as described, is a standalone instrument (Uritest-50 and Uritest-500B Urine Analyzers) that performs semi-quantitative detection on reagent strips. The user manually dips the strip and places it in the analyzer, which then measures and displays results. This effectively performs as an "algorithm only" device in terms of its measurement and result generation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implies that the ground truth for comparison was the performance of predicate devices (Bayer Clinitek 500 Urine Chemistry Analyzer, Bayer Multistix 10-SG Reagent Strips for Urinalysis, Dirui URISTK H-11 Reagent Strips and Dirui H-500 Urine Analyzer). The specific type of ground truth data (e.g., what independent reference method these predicate devices themselves were compared against) is not detailed.

8. The sample size for the training set

Not specified in the provided text.

9. How the ground truth for the training set was established

Not specified in the provided text, and given the nature of the device (semi-quantitative chemical analysis), a "training set" in the context of supervised machine learning might not be directly applicable in the same way it would be for an AI-based image analysis device. However, system calibration and validation would involve known samples. This detail is not provided.

Summary

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510(K) SUMMARY

This summary of 5l0(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: K082811.

1. Submitter's Identification:

Qin Huajuan URIT Medical Electronic Co., Ltd. No. 4 East Alley, Jiuhua Road Guilin, Guangxi, China 541001

Phone: 86 773 3112787 Fax: 86 773 2693847

Date Summary Prepared: August 17, 2009

2. Name of the Device:

Uritest-50 and Uritest-500B Urine Analyzers Uritest 10G Urine Reagent Strips Uritest 11G Urine Reagent Strips

3. Common or Usual Name:

Urine Chemistry Analyzer Urinalysis Reagent Strips

Classification Information: 4.

Division of Clinical Laboratory Devices Panel: Clinical Chemistry (75) Product codes: KQO, JIL, JIP 21 CFR Part 862.2900

5. Predicate Device Information:

Bayer Clinitek 500 Urine Chemistry Analyzer (K926359) Baver Multistix 10-SG Reagent Strips for Urinalysis (K052719) Dirui URISTK H-11 Reagent Strips and Dirui H-500 Urine Analyzer (K040703)

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Device Description: e.

7. Intended Use:

The Uritest-50 and Uritest-500B unine analyzers are semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acidbase balance and bacteriuria. The instruments use the accompanying check strip for daily calibration.

8. Comparison to Predicate Devices:

The Uritest-50 and Uritest-500B Urine Analyzers are reflectance spectrophotometers. It has similar technological characteristics to the CLINITEK 500 Urine Chemistry Analyzer and the Dirui H-500 Urine Analyzer. They are instruments which make it suitable for physician office laboratories. The user manually dips an Uritest 10G or Uritest 11G reagent strip into a urine specimen and places it on the Uritest-50 or Uritest-500B Urine Analyzer. The instrument times the reactions on the strip, measures the reflectance off the strip and converts the results to a clinically meaningful unit that corresponds to the color

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chart on the bottle label of the strip. The urinalysis results are displayed on the instrument and can be printed or transferred to a laboratory computer.

ல் Performance studies:

Studies were conducted in-house and in clinical settings to demonstrate that the performance of the Uritest-50 and Untest-500B Urine Analyzers and Uritest 10G or Uritest 11G urine reagent strips are equivalent to the predicate devices.

10. Conclusions:

The results of in-house and clinical evaluations of the Uritest-50 and Uritest-500B Urine Analyzers and Uritest 10G or Uritest 11G urine reagent strips demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

SEP 1 2009

Urit Medical Electronic Co., Ltd. c/o Ms. Maria Griffin mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K082811

Trade/Device Name: Uritest-50 Urine Analyzer, Uritest-500B Urine Analyzer, Uritest 10G Urine Reagent Strips, Uritest 11G Urine Reagent Strips

Regulation Number: 21 CFR §864.6550

Regulation Name: Occult blood test

Regulatory Class: II

Product Code: JIO, JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JMA, KSL, KQO

Dated: September 9, 2009

Received: September 10, 2009

Dear Ms. Griffin:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820),

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H.

Courtney C. Harper, Ph.D. Acting 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 Form

510(k) Number (if known): (k) 082811

Device Name: Uritest-50 Urine Analyzer, Uritest-500B Urine Analyzer, Uritest 10G Urine Reagent Strips. Uritest 11G Urine Reagent Strips

Indications for Use:

The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for professional, in vitro diagnostic use only.

Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid (Uritest 10G urine reagent strips don't have the ascorbic acid pad), Test results may provide information the status of carbohvdrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The instruments use the accompanying check strip for daily calibration.

Uritest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for professional, in vitro diagnostic use only.

Uritest 11G urine reagent strips provide semi-quantitative tests for leukocvtes, ketone, nitrite. urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Uritest 11G urine reagent strips are for use with Uritest-500B urine analyzer and are for professional, in vitro diagnostic use only.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Cairol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 082811

Page 1 of 1

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.