The iChem100 Urine Chemistry Analyzer (iChem100) is a semiautomated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.

Device Description

The iChem" 100 Urine Chemistry Analyzer is a semi-automated benchtop instrument for the rapid analysis of urine test strips. The iChem100 is designed to analyze and generate results for iChem10 SG Urine Chemistry Strips.

AI/ML Overview

The provided text is a 510(k) summary for the Iris Diagnostics iChem 100 Urine Chemistry Analyzer. It details the device, its intended use, and substantial equivalence to a predicate device, focusing on non-clinical performance studies. However, it does not provide detailed acceptance criteria or the specific results of a study designed to prove the device meets these criteria in the format requested.

Here's an analysis based on the information provided, highlighting what is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the provided text. The document states:

"A correlation study demonstrated substantial equivalence when results from the iChem 100 were compared to the predicate device."
"Additional studies for precision and linearity demonstrated acceptable performance of the iChem 100 System for its intended use."

However, no specific performance metrics (e.g., sensitivity, specificity, accuracy, concordance rates, or quantitative limits for precision and linearity) or their corresponding acceptance criteria are presented in a table format or even as narrative descriptions.

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

This information is not provided in the text. There is no mention of the number of samples used in the "correlation study" or "additional studies for precision and linearity," nor the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the text. The document refers to "non-clinical studies" and comparisons to a "predicate device." It does not mention the involvement of human experts for establishing ground truth, as would be typical for evaluating diagnostic device performance against a gold standard.

4. Adjudication Method for the Test Set

This information is not provided in the text. Since no experts are mentioned for establishing ground truth, no adjudication method would be detailed.

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

This is not applicable and not provided. The iChem 100 is described as a "semi-automated benchtop instrument" and an "algorithm only" device for analyzing urine test strips (reflectance spectroscopy). It does not appear to involve human interpretation of images or data that would be augmented by AI, hence an MRMC study with human readers assisting AI is not relevant to this device's evaluation as described.

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

Yes, implicitly. The description of the iChem 100 as a "semi-automated benchtop instrument" that "automatically move the test strip to the Optical Block for analysis" and "designed to analyze and generate results" strongly suggests a standalone, algorithm-only performance evaluation. The "correlation study" and "precision and linearity" studies would have evaluated the performance of the instrument itself.

7. The Type of Ground Truth Used

The text indicates that the performance was evaluated by comparing it to a "predicate device" and through "precision and linearity" studies. Therefore, the "ground truth" implicitly relies on:

Predicate Device Performance: For the correlation study, the results from the ARKRAY AUTION JET "AJ-4270 Urine Analyzer (K030600)" served as the comparator or "ground truth" for establishing substantial equivalence.
Established Analytical Methods: For precision and linearity, the ground truth would typically be established through controlled samples with known target values, using established analytical methods to determine accuracy and reproducibility.

8. The Sample Size for the Training Set

This information is not provided in the text. The iChem 100 is presented as a medical device for chemical analysis (reflectance spectroscopy), not explicitly as an AI/ML device that requires a distinct "training set" in the common AI sense. While such devices are calibrated and developed using data, the document does not use the terminology of "training set" or specify its size.

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

This information is not provided in the text. As mentioned above, the concept of a "training set" with established ground truth as understood in AI/ML is not explicitly discussed for this device. The development and calibration processes for chemical analyzers typically involve reference materials and established analytical methods.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and general acceptable performance through non-clinical studies (correlation, precision, linearity). However, it lacks the detailed quantitative performance metrics, specific acceptance criteria, sample sizes, and expert ground truth establishment information typically required to fully answer the detailed questions posed about acceptance criteria and study proving its fulfillment.

Summary

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JUN 1 3 2006

510(k) Summary

OWNER'S NAME AND ADDRESS

Iris Diagnostics, a Division of IRIS International Inc. 9172 Eton Avenue Chatsworth, CA 91311

Primary Contact: Gerald J. Haddock, P.E. Phone: (818) 709-1244 ext. 129 Fax: (818) 700-9661

Date of Summary: March 1, 2006

DEVICE NAME:

Proprietary Name: iChem 100™ Urine Chemistry Analyzer Common/Usual Name: Urine Analyzer Classification Name: Automated Urinalysis System

PREDICATE DEVICE:

ARKRAY AUTION JET "AJ-4270 Urine Analyzer (K030600)

DEVICE DESCRIPTION:

INTENDED USE:

Iris Diagnostics Division

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INTENDED USE (CONTINUED):

Blood, Ketones, Nitrite, Leukocyte Esterase, Ascorbic Acid and Color). The iChem 100 is intended for use exclusively by healthcare professionals. The results obtained from the iChem 100 are useful in the evaluation of renal, urinary, and metabolic disorders

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The indicated use of the proposed and predicate urine analyzers is the same. Both systems (instruments and associated strips) provide qualitative and semi-quantitative measurements of urine analytes using multi-parameter test strips.

The overall design of the proposed iChem 100 Urine Analyzer is very similar to the predicate. Both of these analyzers are semi automated, requiring that the user dip a test strip in the urine and place the test strip on a tray in the analyzers then time the reaction on the strip and automatically move the test strip to the Optical Block for analysis.

The proposed iChem 100 Urine Analyzer and the predicate AUTION JET™ AJ-4270 use reflectance spectroscopy for the measurement of all urine analytes. The proposed iChem 100 Urine Analyzer, and the predicate AUTION JET use reflectance spectroscopy for urine color determination. The proposed device implements the sensing function with a CMOS camera, compared to a photodiode used on the predicate device. Both units are microprocessor controlled.

The iChem 100 Urine Analyzer is indicated for use with iChem 10 SG Urine Chemistry test strips. The proposed iChem 10 SG strips are similar to the AUTION Sticks10EA that are indicated for use with the predicate AUTION JET AJ-4270, with the exception that the iChem 10 SG test strips contain a reagent pad for the measurement of Ascorbic Acid. The measurement of ascorbic acid on the iChem 100 is intended as a warning to the operator of potential interference with other tests due to elevated levels of ascorbic acid. The AUTION Sticks 10EA do not contain a reagent pad for the measurement of Ascorbic Acid

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 iChem 10 SG strips and the predicate AUTION JET™ 10 EA test strips.

PERFORMANCE TESTING

Non-clinical studies were conducted to evaluate the performance of the iChem 100 Automated Urine Analyzer. A correlation study demonstrated substantial equivalence when results from the iChem 100 were compared to the predicate device. Additional studies for precision and linearity demonstrated acceptable performance of the iChem 100 System for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus in the logo is a modern interpretation, featuring three curved lines that converge at the bottom, resembling a stylized representation of a staff with snakes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Gerald J. Haddock P.E. Director, Quality Assurance and Regulatory Affairs Iris Diagnostics, a Division of IRIS International, Inc. 9172 Eton Avenue Chatsworth, CA 91311

JUN 1 3 2006

K060280 Re:

Trade/Device Name: iChem™ 100 Urine Chemistry Analyzer and iChem™ 10 SG strips Regulation Number: 21 CFR§862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, JMA, JJB, JIN, JMT, CEN, JIR, CDM, JJQ, LJX, KQO Dated: June 2, 2006 Received: June 3, 2006

Dear Mr. Haddock:

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 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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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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours.

Alberto Gutierrez

Alberto Gutierrez, Ph.D. 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

510(k) Number (if known): K060280

iChem™ 100 Urine Chemistry Analyzer and iChem™ 10 SG strips Device Name:

Indications For Use: The iChem100 Urine Chemistry Analyzer (iChem100) is a semiautomated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals.

These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.

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 IF NEEDED)

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

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060270

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.