The iQ 200 System is intended for analysis of urine chemistry, color, clarity, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.

The iQ 200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.

Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations.

Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of postsurqical or post-therapeutic recovery.

The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

Device Description

The iQ 200 System provides automatic sample handling for automated intelligent microscopy and automatic analyte classification for improved data reporting, presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Each image is analyzed and assigned a classification by an auto analyte recognition algorithm. Using these classifications and the known observation volume, microscopic analyte concentrations may be automatically reported. If results from a specimen are not autoreported, microscopic examination results are displayed on an independent Computer WorkStation. Operators can then confirm or modify analyte classifications and release reports off-line for enhanced convenience, obviating the need to process a second aliquot for review. Chemistry results from the companion ARKRAY AUTION MAX AX-4280 are automatically consolidated by the Computer WorkStation for display and reporting.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the iQ™ 200 System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria. Instead, it describes the performance relative to predicate devices and relative to expert human identification. The acceptance criteria can be inferred from the "Conclusions Drawn From Clinical Tests" section.

Feature/Metric	Acceptance Criteria (Inferred)	Reported Device Performance (iQ™ 200 System)
Clinical Sensitivity (Abnormal specimens)	Exceed clinical sensitivity of predicate devices (939UDx Urine Pathology System and Sysmex UF-100).	Exceeded that of the 939UDx Urine Pathology System and Sysmex UF-100. Generally had greater sensitivity for detection of individual microscopic formed elements than either predicate device.
Clinical Specificity (Normal specimens)	Comparable to predicate devices (939UDx Urine Pathology System and Sysmex UF-100).	Comparable. When sensitivity for each microscopic formed element was fixed at 90%, iQ™ 200 System specificity was greater than that of either predicate device for most formed elements.
Automated Reported Concentrations (RBC, WBC, Squamous Epithelial Cells, Casts)	Match those determined from expert human identification, or match those of predicate device (939UDx) when measured by the square of the regression correlation coefficient (R Square).	Matched those determined from expert human identification as well as the 939UDx Urine Pathology System predicate automatically reported concentrations matched those of the human expert when measured by the square of the regression correlation coefficient, R Square.
Suitability for Intended Use	The device should be shown to be suitable for its intended use, which is automating the complete urinalysis profile including urine test strip chemistry panel and microscopic sediment analysis, producing quantitative or qualitative counts of formed elements, and allowing for operator review and override.	The iQ™ 200 System has been shown to be suitable for its intended use.

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

Test Set Sample Size: Not explicitly stated. The document mentions "specimens" and "individual microscopic formed elements" but doesn't provide a numerical count for the test set used in the comparative studies.
Data Provenance: Not explicitly stated. The document refers to "clinical sensitivity" and "clinical specificity," suggesting the data was collected in a clinical setting, but it does not specify the country of origin or whether it was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The document refers to "expert human identification" in the context of establishing ground truth for automated reported concentrations but does not specify the number of experts involved.
Qualifications of Experts: The experts are referred to generally as "expert human identification" or "human expert." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided within this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The document mentions "a competent human operator can set criteria for auto-reporting and flagging specimens for review" and "All instrument analyte image decisions may be reviewed and overridden by a trained technologist." This indicates a human-in-the-loop process where human review and override are possible, but it does not detail a specific adjudication method for establishing the initial ground truth for comparative studies (e.g., 2+1, 3+1 consensus).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

The document describes comparative performance studies of the iQ™ 200 System against predicate devices (939UDx Urine Pathology System and Sysmex UF-100) and against "expert human identification."
However, it does not describe a Multi Reader Multi Case (MRMC) comparative effectiveness study where human readers' performance with AI assistance is compared to their performance without AI assistance. The study focuses on the standalone performance of the iQ™ 200 system (which includes an auto analyte recognition algorithm) against existing automated systems and human expert classification.
Therefore, no effect size for human reader improvement with AI assistance is reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was done. The "Summary of Technological Characteristics" states, "Each image is analyzed and assigned a classification by an auto analyte recognition algorithm." The "Conclusions Drawn From Clinical Tests" section directly compares the "iQ™ 200 System automatically reported concentrations" to "expert human identification" and predicate device results, indicating that the automatic classification (algorithm only) performance was evaluated. The device is designed for auto-reporting, though human review is an option.

7. The Type of Ground Truth Used

The primary type of ground truth used was expert human identification/consensus. This is explicitly stated: "iQ™ 200 System automatically reported concentrations of RBC, WBC, squamous epithelial cells and casts matched those determined from expert human identification..."

8. The Sample Size for the Training Set

Not specified. The document does not provide any information regarding the sample size used for training the "auto analyte recognition algorithm."

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

Not specified. The document does not describe how the ground truth was established for any training data used to develop the auto analyte recognition algorithm.

Summary

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OCT 21 2002

International Remote Imaging Systems, Inc.

9162 Eton Avenue, Chatsworth, CA 91311

818-709-1244 800-776-4747 FAX 818-700-9661

510(k) SUMMARY

510(k) Submission: K022774

iQ™ 200 System

General Information:

Date of Submission:	August 20, 2002
Trade Name of Device:	iQ™ 200 System
Common Name of Device:	Automated urinalysis system
Classification Name:	Automated urinalysis system,21 CFR 862.2900, Class IMicroscope, 21 CFR 862.3600, Class IAutomated cell counter (Urine particle counter),21 CFR 864.5200, Class II
Submitter's Name:	Harvey L. Kasdan, Ph.D.Chief ScientistIris Diagnostics, A Division ofInternational Remote Imaging Systems, Inc.9162 Eton Avenue, Chatsworth, CA 91311
Indications for Use (Brief):	The iQ 200 System is intended for analysis of urine chemistry,color, clarity, specific gravity, and formed sediment elements,which constitutes typical routine urinalysis.
Intended Use:	The iQ 200 System is an in-vitro diagnostic device used toautomate the complete urinalysis profile, including urine teststrip chemistry panel and microscopic sediment analysis.Optionally, the iQ 200 Analyzer can be used as a stand-aloneunit, or the results from the iQ 200 Analyzer can be combinedwith other urine chemistry results received from an LIS. Itproduces quantitative or qualitative counts of all formedsediment elements present in urine, including cells, casts,crystals, and organisms. A competent human operator can setcriteria for auto-reporting and flagging specimens for review.All instrument analyte image decisions may be reviewed andoverridden by a trained technologist.
Substantial Equivalenceto Predicate Devices:	The iQ 200 System is substantially equivalent underSection 510(k) of the Food, Drug, and Cosmetic Act to TheYellow IRIS® Urinalysis Workstation with CHEMSTRIP®Reader, the IRIS Flow Microscope, the 900UDx UrinePathology System, the 939UDx Urine Pathology System, andthe Sysmex UF-100.
Summary ofTechnologicalCharacteristics:	The iQ 200 System provides automatic sample handling forautomated intelligent microscopy and automatic analyteclassification for improved data reporting, presentation andmanagement. Specimens are aspirated by an autosamplerrather than poured manually. Each image is analyzed andassigned a classification by an auto analyte recognitionalgorithm. Using these classifications and the knownobservation volume, microscopic analyte concentrations maybe automatically reported. If results from a specimen are notautoreported, microscopic examination results are displayed onan independent Computer WorkStation. Operators can thenconfirm or modify analyte classifications and release reportsoff-line for enhanced convenience, obviating the need toprocess a second aliquot for review. Chemistry results fromthe companion ARKRAY AUTION MAX AX-4280 areautomatically consolidated by the Computer WorkStation fordisplay and reporting.
Performance Studies:	Microscopic analysis performance of the iQ 200 System werecompared with that of 939UDx Urine Pathology System andthe Sysmex UF-100.
Conclusions DrawnFrom Clinical Tests:	Clinical sensitivity (fraction of abnormal specimens detected)of the iQ 200 System exceeded that of the 939UDx UrinePathology System and Sysmex UF-100, while clinicalspecificity (fraction of normal specimens detected) wascomparable. The iQ 200 System generally had greatersensitivity for detection of individual microscopic formedelements than either the 939UDx Urine Pathology System orthe Sysmex UF-100. With sensitivity for detection of eachmicroscopic formed element fixed at 90%, iQ 200 Systemspecificity was greater than that of either the 939UDx UrinePathology System or Sysmex UF-100 for most formedelements. iQ 200 System automatically reportedconcentrations of RBC, WBC, squamous epithelial cells andcasts matched those determined from expert humanidentification as well as the 939UDx Urine Pathology Systempredicate automatically reported concentrations matched thoseof the human expert when measured by the square of theregression correlation coefficient, R Square. The iQ 200System has been shown to be suitable for its intended use.

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Comments of the management would and the

and the charge compression with the first charges of the charges on the charges of the charges of the charges of the charges of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

OCT 21 2002

Food and Druig Administratio ockville MD 20850

Harvey L. Kasdan, Ph.D.. Chief Scientist International Remote Imaging Systems, Inc. 9172 Eton Avenue Chatsworth, California 91311-5874

K022774 Re:

Trade/Device Name: iQ™ 200 System Regulation Number: 21 CFR § 864.5200 Regulation Name: Automated Cell Counter Regulatory Class: II Product Code: LKM, KQO Dated: August 20, 2002 Received: August 21, 2002

Dear Dr. Kasdan:

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 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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PREMARKET NOTIFICATION

510(k) Number (if known):

Device Name: iQ 200 System

Indications for Use

The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis.

Caroline Richter

(Division Sign-Off) Division of Clinical Laboratory Devices 510kj Number

Regulation Number and Section

§ 864.5200 Automated cell counter.

(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).