The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose (GLU), protein (PRO), bilirubin (BIL), urobilinogen (URO), pH, blood (BLD), ketones (KET), nitrite (NIT), leukocytes (LEU), specific gravity (SG), turbidity, and color. The AUTION MAX is intended for use only with the AUTION Sticks 9EB multi-parameter test strips.

Device Description

The AUTION MAX Urinalysis System consists of an Analyzer, Sampler, and accessories. ARKRAY also offers an external printer and hand-held Bar Code Reader for use with the AUTION MAX. The sample-handling capacity of the AUTION MAX can be expanded through the use of the Extensional Sampler. The AUTION MAX Analyzer is designed for use with the AUTION Sticks 9EB multiparameter test strips.

The proposed AUTION MAX Analyzer contains:

Mechanical systems for handling the test strips, urine specimens, wash solution, and system waste
Measurement units for reading the test strips and analyzing the physical properties of the urine
Software control system for automation of Analyzer and Sampler operation, processing commands and information input by the user, displaying system and specimen information, and monitoring system functions
RS-232C interface for exporting measurement results and urine specimen identification information
The AUTION MAX uses a rack system for urine specimen handling. The AUTION MAX Sampler automatically feeds sample racks to the Analyzer. The Sampler contains a Bar Code Reader for urine specimen identification.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided for the AUTION MAX™ AX-4280 Urinalysis System:

Acceptance Criteria and Device Performance Study for AUTION MAX™ AX-4280 Urinalysis System

The provided documentation states that "Several studies were conducted to evaluate the performance characteristics of the AUTION MAX Urinalysis System. A correlation study demonstrated excellent agreement when results from the AUTION MAX were compared to those from a commercially available automated urine analyzer. Additional studies for precision, carryover, and linearity demonstrated acceptable performance of the AUTION MAX System for its intended use."

However, specific acceptance criteria values (e.g., specific thresholds for correlation coefficients, precision limits, carryover percentages, or linearity ranges) are not explicitly detailed in the provided text. Similarly, the reported numerical device performance against these non-specified criteria is also not given. The statement merely indicates "excellent agreement" and "acceptable performance."

Therefore, the table below reflects what can be inferred from the provided text, acknowledging the lack of quantitative detail.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Correlation	Excellent agreement with a commercially available automated urine analyzer.	Demonstrated excellent agreement with a commercially available automated urine analyzer (e.g., Clinitek Atlas or Chemstrip Super UA).
Precision	Acceptable performance for intended use.	Demonstrated acceptable performance.
Carryover	Acceptable performance for intended use.	Demonstrated acceptable performance.
Linearity	Acceptable performance for intended use.	Demonstrated acceptable performance.

Additional Study Information:

Due to the limited detail in the provided 510(k) summary, specific answers for many of the requested categories are not available.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study primarily focused on comparison with another automated analyzer rather than expert-established ground truth for individual analytes in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Given the comparative nature with existing automated devices, a traditional expert adjudication method for ground truth might not have been the primary method for this type of performance testing in this context.
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 was not done. This device is an automated urinalysis system, not an AI-assisted diagnostic tool for human readers. Its purpose is to perform the analysis independently.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The performance testing described (correlation, precision, carryover, linearity) evaluates the AUTION MAX™ AX-4280 Urinalysis System as a standalone automated device without direct human-in-the-loop performance influencing the measurement of the analytes. The system is designed to provide automated results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "correlation study," the "ground truth" was established by the results from a commercially available automated urine analyzer (specifically a predicate device like the Clinitek Atlas or Chemstrip Super UA). For precision, carryover, and linearity studies, the ground truth would be based on known concentrations or control materials as per standard laboratory validation protocols, though not explicitly stated as "ground truth."
The sample size for the training set:
- Not applicable/Not specified. This is a medical device, not a machine learning model that undergoes a distinct "training" phase with a specific training set in the context of typical AI model development. The system's "training" would be its inherent design, calibration, and manufacturing process.
How the ground truth for the training set was established:
- Not applicable/Not specified for the reasons stated above. Its performance is validated against predicate devices and standard analytical measurements.

Summary

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JAN 1 8 2002

510(k) Summary

K013783

for

AUTION MAX™ AX-4280 Urinalysis System

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

November 12, 2001 Date Prepared:

2. DEVICE NAME

Proprietary Name:	AUTION MAX AX-4280 Urinalysis System
Common/Usual Name:	Urinalysis System
Classification Name:	Automated Urinalysis System

PREDICATE DEVICES 3.

Clinitek Atlas Automated Urine Chemistry Analyzer, Bayer Corporation ● (K946183)
Chemstrip® Super UA™ Automated Urine Analyzer, Boehringer Mannheim . Corporation (K983510)

DEVICE DESCRIPTION 4.

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AUTION MAX Analyzer is designed for use with the AUTION Sticks 9EB multiparameter test strips.

INTENDED USE ર.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The AUTION MAX is substantially equivalent to the Clinitek Atlas Automated Urine Chemistry Analyzer with Rack Sample Handler (Clinitek Atlas), manufactured by Bayer Corporation (K946183). The Clinitek Atlas is intended for use with the Clinitek® Atlas® Reagent Pack reagent strips. Both the proposed AUTION MAX and the Clinitek Atlas measure urine GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, SG, color, and clarity.

The AUTION MAX is also substantially equivalent to the Chemstrip® Super UATM Automated Urine Analyzer (Chemstrip Super UA), manufactured by Boehringer Mannheim Corporation (K983510). The Chemstrip Super UA is intended for use with the Chemstrip® 10 S-UA urine test strips. The Chemstrip Super UA measures urine GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, and SG.

The proposed AUTION MAX Analyzer contains:

Mechanical systems for handling the test strips, urine specimens, wash . solution, and system waste
Measurement units for reading the test strips and analyzing the physical . properties of the urine
Software control system for automation of Analyzer and Sampler operation, . processing commands and information input by the user, displaying system and specimen information, and monitoring system functions

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RS-232C interface for exporting measurement results and urine speciment . identification information
The AUTION MAX uses a rack system for urine specimen handling. The AUTION MAX Sampler automatically feeds sample racks to the Analyzer. The Sampler contains a Bar Code Reader for urine specimen identification.

The overall design of the predicate Clinitek Atlas and the Chemstrip Super UA is similar to that of the proposed AUTION MAX, with the exception that the urine specimens are transported to the Chemstrip Super UA analyzer using a turntable rather than a rack system.

The proposed AUTION MAX Analyzer uses reflectance spectroscopy for the measurement of the urine analytes GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, and urine color. Urine SG is determined using the refractive index method, and turbidity is evaluated by measuring the transmission and scattering of light passing through the urine specimen. These analytical methods are identical to the methods used by the predicate Clinitek Atlas. The predicate ChemStrip Super UA uses reflectance spectroscopy for the measurement of all urine analyte species, including SG.

The AUTION Sticks 9EB multi-parameter test strips contain reactive pads impregnated with reagents formulated to react with a specific urine analyte. Each strip also contains a correction pad with no reagents for urine color determination. Like the proposed AUTION Sticks, the Clinitek Atlas reagent strips and the Chemstrip 10 S-UA test strips consist of reagent pads on a non-reactive plastic backing.

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 and The chemical constituents of the individual reagent predicate test strips. 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.

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7. PERFORMANCE TESTING

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

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JAN 1 8 2002

Re: K013783

Trade/Device Name: AUTION MAXTM AX-4280 URINALYSIS SYSTEM Regulation Number: 21 CFR 862.2900, 862.1785, 862.1340, 862.1435, 864.6550, 862.1645, 862.1115, 862.1510, 862.2800, 864.7675 Regulation Name: Automated Urinalysis System, Urinary urobilinogen (nonquantitative) test system, Urinary pH (nonquantitative) test system, Urinary glucose (nonquantitative) test system, Ketones (nonquantitative) test system, Occult blood test, Urinary protein or albumin (nonquantitative) test system, Urinary bilirubin and its conjugates (nonquantitative) test system, Nitrite (nonquantitative) test system, Refractometer for clinical use, Leukocyte peroxidase test Regulatory Class: Class I, II Product Code: KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX Dated: November 12, 2001 Received: November 14, 2001

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, 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 (OS) 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 I his lotton will and it 300 ding of substantial equivalence of your device to a legally marketed nouticate 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 If you desire arrivation and in the diagnostic devices), please contact the Office of Compliance at additionally 607.10 101 ====================================================================================================================================================== (201) 594-1560. Traditional (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 miormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrf/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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510(k) Number (if known): గ013783

Device Name: _AUTION MAX™ AX-4280 Urinalysis System

Indications for Use:

The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an The "TO FOTO - 12 22" analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, in tri allarytes. Eracobo, provity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.

Sean Cooper

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

November 12, 2001

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.