The PocketChem™UA is a urine chemistry analyzer and is intended for use with the AUTION Sticks 10TA for the determination of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine. The tests provided by the use of the PocketChem™UA and the AUTION Sticks 10TA are considered routine urinalysis at the following levels of detection:

Analyte	Level of Detection
Glucose	50 mg/dL - 1000 mg/dL
Protein	15 mg/dL - 1000 mg/dL
Bilirubin	0.5 mg/dL - Over (>6 mg/dL)
Urobilinogen	2 mg/dL - Over (>8 mg/dL)
pH	5.0 - 9.0
Specific Gravity	<1.005 - >1.030
Blood (Hemolysis and Non Hemolysis)	0.06 mg/dL - 1.0 mg/dL
Ketones	5 mg/dL - 150 mg/dL
Nitrite	NEG - 2+
Leukocytes	25 Leu/µL - 500 Leu/µL

For professional use only.

Device Description

Automated urine chemistry analyzer - a urinalysis system for the measurement of certain physical properties and chemical constituents of urine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ARKRAY PocketChem™UA AUTION Stick 10TA, based on the provided 510(k) submission:

Acceptance Criteria and Device Performance

The provided document describes the device's performance in comparison to a predicate device, the Bayer Clinitek 50 / MULTISTIX 10SG Reagent Strips. The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence and strong correlation with the predicate device.

Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Analyte	Acceptance Criteria (Implicit: strong correlation to predicate)	Reported Device Performance
Glucose	High correlation (e.g., >95% agreement) with the predicate device for both negative and positive samples.	ARKRAY correlated 97.7% for Glucose with the Bayer System for both negative and positive samples.
Blood (Hemolysis and Non Hemolysis)	High correlation (e.g., >95% agreement) with the predicate device for both negative and positive samples.	ARKRAY correlated 100% for Blood with the Bayer System for both negative and positive samples.
Other analytes (Protein, Bilirubin, Urobilinogen, pH, Specific Gravity, Ketones, Nitrite, Leukocytes)	Implicitly, demonstration of comparable performance and reliability to the predicate device would be required. The document states the system detects 10 analytes as per routine urinalysis.	While specific percentages for all analytes are not explicitly stated, the document concludes that the "ARKRAY PocketChem™ and AUTION Stick 10TA is substantially equivalent to the Clinitek 50 and MULTISTIX 10SG Reagent Strips manufactured by Bayer Corporation."
Manual Read Performance	High correlation between manual visual reading of the strips and the automated PocketChem™UA system.	The manual read of the AUTION Sticks 10TA compared to the PocketChem™UA System correlated 100% of the samples.
Reproducibility and Precision	Consistency of results across repeated measurements and different concentrations.	Results confirmed the reproducibility and precision of the ARKRAY PocketChem™UA and AUTION Sticks 10TA throughout the entire range of detection, including extreme negative and positive samples, using control-matrix samples.

Study Details:

Sample Size used for the test set and the data provenance:
- Sample Size: Three hundred and two (302) clinical samples were tested for routine urinalysis. Specifically, 30 positive samples were found for glucose and 60 positive for blood within this set.
- Data Provenance: The document does not explicitly state the country of origin. It describes them as "clinical samples," implying they were collected from patients. It is a retrospective study design since the samples were pre-collected to be tested against the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth for the test set. Instead, the "ground truth" for the comparative study was established by the predicate device (Bayer Clinitek 50 & MULTISTIX 10SG).
Adjudication method for the test set:
- Since the comparison was primarily against a predicate device, and also between the automated system and manual read of the strips, formal expert adjudication of a "ground truth" in the typical sense (e.g., 2+1 radiologist consensus) is not applicable or described. The predicate device's results served as the reference.
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, an MRMC comparative effectiveness study involving human readers improving with AI assistance was not conducted or described. This submission pertains to an automated urine chemistry analyzer, not an AI-assisted diagnostic tool for human interpretation. The closest related test was the comparison between the automated system and a manual read of the strips, but this was to show agreement between two modes of utilizing the same test strip, not human improvement with AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation of the ARKRAY PocketChem™UA system was implicitly done, as its results were directly compared to the predicate device (Bayer Clinitek 50). The system functions as an automated analyzer, meaning it operates without direct human interpretive input beyond sample loading and result verification.
The type of ground truth used:
- The ground truth for the comparative study was the predicate device's measurements (Bayer Clinitek 50 & MULTISTIX 10SG). For the manual read comparison, the automated system's reading served as a reference to the manual reading of the same strips. For reproducibility and precision, control-matrix samples with known (spiked) concentrations were used.
The sample size for the training set:
- The document does not provide information regarding a separate training set. Urine chemistry analyzers like the PocketChem™UA often rely on calibrated optical systems and reagent chemistry rather than machine learning models that require distinct "training" datasets in the typical AI sense.
How the ground truth for the training set was established:
- As no training set is described in the context of machine learning, this question is not applicable. The device's calibration and performance would be established through a manufacturing and quality control process using known standards and control materials.

Summary

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510k Submission ARKRAY, Inc.

1622386

SEP 1 7 2002

510 (K) SUMMARY

Date of Summary

July 19, 2002

Product Name:

PocketChem™UA AUTION Stick 10TA

Sponsor & Manufacturer:

ARKRAY, Inc. 57 NISHI AKETA-CHO, HIGASHI-KUJO MINAMI-KU, KYOTO, 601-8045, JAPAN FDA Registration #: 961144

US Distributor

Thermo BioStar 331 S. 104th Street Louisville, CO 80027

Correspondent:

Fran White MDC Associates 163 Cabot Street Beverly, MA 01915

Substantially Equivalent Device:

Product: Clinitek 50 / MULTISTIX 10SG Reagent Strips Manufactured by: Bayer Corp 510k Number: K960546

Product Description:

Automated urine chemistry analyzer - a urinalysis system for the measurement of certain physical properties and chemical constituents of urine.

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510k Submission ARKRAY. Inc.

Intended Use:

PocketChem™UA is a urine chemistry analyzer intended for the simultaneous detection of multiple chemistry analytes in urine. PocketChem™UA is intended for use in routine urinalysis – for the semiqualitative detection of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine at the following levels of detection:

Analyte	Level of Detection
Glucose	50 mg/dL - 1000 mg/dL
Protein	15 mg/dL - 1000 mg/dL
Bilirubin	0.5 mg/dL - Over (>6 mg/dL)
Urobilinogen	2 mg/dL - Over (>8 mg/dL)
pH	5.0 - 9.0
Specific Gravity	<1.005 - >1.030
Blood (Hemolysis and Non Hemolysis)	0.06 mg/dL - 1.0 mg/dL
Ketones	5 mg/dL - 150 mg/dL
Nitrite	NEG - 2+
Leukocytes	25 Leu/µL - 500 Leu/µL

ARKRAY PocketChem™UA and AUTION Sticks 10TA are intended for professional use only.

Performance Characteristics:

ARKRAY PocketChem™UA and AUTION Stick 10 TA System detect 10 analytes measured in routine urinalysis.

ARKRAY PocketChem™ and AUTION Stick 10TA is substantially equivalent to the Clinitek 50 and MULTISTIX 10SG Reagent Strips manufactured by Bayer Corporation 510k number K960546.

Product performance was compared to the Baver System (Clinitek50 & MULTISTIX 10SG). Three hundred and two (302) clinical samples were tested for routine urinalysis. 30 positive samples were found for glucose and 60 positive for blood.

In comparison to the Bayer system, ARKRAY was proven to correlate results of 97.7% for Glucose and 100% for Blood for both negative and positive samples. The manual read of the AUTION Sticks 10TA compared to the PocketChem™UA System in correlated 100% of the samples.

Reproducibility and precision was evaluated using control-matrix samples spiked with varying concentrations of glucose and blood; throughout the entire range of detection, including extreme negative and positive samples. The results confirmed the reproducibility and precision of the ARKRAY PocketChem™JA and the AUTION Sticks 10TA.

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510k Submission ARKRAY, Inc.

Conclusion:

ARKRAY PocketChem™UA and AUTION Sticks 10TA are substantially equivalent as an automated system and as manual-read strips to Bayer's Clinitek 50 and MULTISTIX 10SG Reagent Strips (K960546) as an automated urinalysis system and reagent strips for visual interpretation.

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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 features a stylized eagle or bird design with three curved lines representing the wings and body. The logo is surrounded by the text "U.S. HEALTH & HUMAN SERVICES DEPARTMENT" in a circular arrangement.

Public Health Service

198 Gaither Boar Rockville MD 20850

FP 1 7 2002

Arkray, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915

Re: K022386

Trade/Device Name: PacketChem™UA & AUTION Stick 10TA Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL; JIP; KQO Dated: July 19, 2002 Received: July 22, 2002

Dear Ms. White:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510k Submission ARKRAY, Inc.

510(k) Number: Device Name:

PocketChem™UA & AUTION Stick 10TA

Indication for Use:

Analyte	Level of Detection
Glucose	50 mg/dL - 1000 mg/dL
Protein	15 mg/dL - 1000 mg/dL
Bilirubin	0.5 mg/dL - Over (>6 mg/dL)
Urobilinogen	2 mg/dL - Over (>8 mg/dL)
pH	5.0 - 9.0
Specific Gravity	<1.005 - >1.030
Blood (Hemolysis and Non Hemolysis)	0.06 mg/dL - 1.0 mg/dL
Ketones	5 mg/dL - 150 mg/dL
Nitrite	NEG - 2+
Leukocytes	25 Leu/µL - 500 Leu/µL

For professional use only.

Jean Cooper

(Divi
Divi ces
510(x, KC22386

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use (Optional Format 1-2-96)

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.