The AUTION™ JET AJ-4270 Urine Analyzer (AUTION™ JET) is a semi-automated urine analyzer and is intended for use with the AUTION™ Sticks 10EA multi-parameter test strips for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocytes, and color. The AUTION™ JET Analyzer and AUTION™ Sticks 10EA test strips are intended for mutually exclusive use as a system.

Device Description

The AUTION™ JET AJ-4270 Urine Analyzer (AUTION™ JET) consists of an analyzer and accessories. ARKRAY also offers a hand-held Bar Code Reader for use with the AUTION™ JET. The AUTION™ JET Analyzer is designed for use only with the AUTIONTM Sticks 10EA multi-parameter test strips.

AI/ML Overview

The provided text doesn't explicitly state quantitative acceptance criteria or a detailed study report with specific performance metrics beyond general statements. However, based on the information given, here's a structured response outlining what can be inferred:

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

Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Excellent Agreement (Correlation)	"excellent agreement when results from the AUTION™ JET were compared to those from a commercially available automated urine analyzer."
Acceptable Precision	"precision... demonstrated acceptable performance of the AUTION™ JET System for its intended use."
Acceptable Linearity	"linearity... demonstrated acceptable performance of the AUTION™ JET System for its intended use."
Substantial Equivalence to Predicate Devices	Device found substantially equivalent to predicate devices (Chemstrip 101 Urine Analyzer, AUTION MAX™ AX-4280 Urine Analyzer, Clinitek Atlas Automated Urine Chemistry Analyzer) after performance testing.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin or whether it was retrospective or prospective). It only states that "Several studies were conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication method for the test set

The document does not mention any adjudication method used for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The AUTION™ JET AJ-4270 Urine Analyzer is an automated device, not an AI system designed to assist human readers.

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

Yes, a standalone performance evaluation was conducted, as the AUTION™ JET is an automated urine analyzer designed to perform measurements "semi-automated," meaning it processes the test strips and provides results without continuous human interpretation of the actual measurement process.

7. The type of ground truth used

The document implies that the ground truth for the performance studies was established by comparing the AUTION™ JET's results to those of "a commercially available automated urine analyzer," which would serve as a reference or "gold standard" for the correlation study. For precision and linearity, the ground truth would typically be based on known concentrations or repeated measurements from controlled samples.

8. The sample size for the training set

The document does not specify a training set sample size. This device is not described as a machine learning or AI-driven system that would typically undergo a "training" phase in the conventional sense. Its performance is based on established reflectance spectroscopy principles and chemical reactions.

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

Not applicable for this device as it's not described as an AI/machine learning system with a distinct training phase. Its performance is based on its inherent design, and its accuracy validated against established methods or reference standards.

Summary

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JUL 1 1 2003

510(k) Summary for AUTION™ JET AJ-4270 Urine Analyzer

1. SPONSOR

International Remote Imaging Systems, Inc. 9162 Eton Avenue Chatsworth, CA 91311

Contact Person:	William M. Dougherty
	Manager
	Quality Assurance and Evaluations
Telephone:	818-709-1244, ext. 140

June 12, 2003 Date Prepared:

2. DEVICE NAME

Proprietary Name:	AUTION TM JET AJ-4270 Urine Analyzer
Common/Usual Name:	Urine Analyzer
Classification Name:	Automated Urinalysis System

3. PREDICATE DEVICES

Chemstrip 101 Urine Analyzer (K983510) .
AUTION MAX™ AX-4280 Urine Analyzer (K013783) .
Clinitek Atlas Automated Urine Chemistry Analyzer (K946183) .

4. DEVICE DESCRIPTION

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ഗ് INTENDED USE

The AUTION™ JET AJ-4270 Urine Analyzer (AUTIONTM JET) is a semiautomated urine analyzer and is intended for use with the AUTION™ Sticks 10EA multi-parameter test strips for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH. specific gravity, blood, ketones, nitrite, leukocytes, and color. The AUTION™ JET Analyzer and AUTION™ Sticks 10EA test strips are intended for mutually exclusive use as a system.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The indicated use of the proposed and predicate urine analyzers is identical. All of these urine analyzers provide qualitative and semi-quantitative measurement of urine analytes using multi-parameter test strips for the measurement of the urine analytes.

The overall design of the proposed AUTION™ JET Analyzer is identical to the predicate Chemstrip 101 Urine Analyzer. Both of these analyzers are semiautomated, requiring that the user dip a test strip in the urine and place the test strip on a tray in the analyzer. The analyzers then time the reaction on the strip and automatically move the test strip to the Optical Block for analysis. The predicate AUTION MAX™ and Clinitek Atlas Analyzers are fully automated and contain mechanical systems for urine specimen handling and sampling in addition to those for test strip handling and analysis.

The proposed AUTION™ JET and the predicate Chemstrip 101 Analyzers use reflectance spectroscopy for the measurement of all urine analyte species. The proposed AUTIONTM JET also uses reflectance spectroscopy for urine color determination. Urine color determination is not performed by the Chemstrip 101.

The predicate AUTION MAX™ and Clinitek Atlas Analyzers use reflectance spectroscopy for the measurement of all urine analyte species and urine color determination, with the exception of urine SG. The AUTION MAX™ and Clinitek Atlas Analyzers use the refractive index method for SG determination.

The AUTION™ JET is indicated for use with the AUTION™ Sticks 10EA multiparameter test strips. The proposed AUTIONTM Sticks 10EA are identical to the AUTION™ Sticks 9EB that are indicated for use with the predicate AUTION MAX™, with the exception that the AUTION™ Sticks 10EA test strips contain a reagent pad for SG determination. The AUTION™ Sticks 9EB do not contain a reagent pad for the measurement of SG. The AUTION MAX™ and Clinitek Atlas determine urine SG by the refractive index method.

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The mechanisms of action for the chemical reactions used for the determination of urinary analytes, including glucose and occult blood, are similar for the proposed AUTION™ Sticks 10EA test strips and the predicate Clinitek Atlas reagent strips and Chemstrip 10UA test strips. The chemical constituents of the individual reagent formulations are similar for the proposed and predicate reagent pads, with minor differences in the choice of enzyme substrate and chromogens used for production of the colored endproduct.

7. PERFORMANCE TESTING

Several studies were conducted to evaluate the performance characteristics of the AUTION™ JET Urine Analyzer. A correlation study demonstrated excellent agreement when results from the AUTION™ JET were compared to those from a commercially available automated urine analyzer. Additional studies for precision and linearity demonstrated acceptable performance of the AUTION™ JET System for its intended use.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles hair or fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 1 2003

International Remote Imaging System c/o Ms. Cynthia J.M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K030600 Trade/Device Name: AUTION™ JET AJ-4270 Urine Analyzer Regulation Number: 21 CFR 862.2900 Regulation Name: Automated urinalysis system Regulatory Class: Class I Product Code: KOO: JIL; JIO Dated: June 12, 2003 Received: June 13, 2003

Dear Dr. Nolte:

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 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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K030600

Device Name: AUTION™ JET AJ-4270 Urine Analyzer

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

תערו Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) K030600

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

June 12, 2003

Appendix A • Page 1

Regulation Number and Section

§ 862.2900 Automated urinalysis system.

(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(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.