The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids.

Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses.

The information produced by the iQ 200 Urine Analyzer Body Fluids Module concerning the cell concentrations in CSF and serous body fluids 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. Cell count findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

Device Description

Two aliquots from each body fluid specimen sample are prepared. One aliquot is diluted in normal saline to provide a concentration in the linear range of the instrument. The second aliquot is treated with a lysing reagent to allow unambiguous identification of nucleated cells by eliminating RBC confusion. Particle images are captured and saved electronically as the sample flows past a microscope objective at a high speed, electronically concentrating particles. Particle images are then ordered by size into assigned categories on a video display. A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the iQ® 200 Urine Analyzer Body Fluids Module, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was compared to manual chamber counting. The acceptance criteria were not explicitly stated as distinct numerical thresholds, but rather implied by the statistical results (R2 values, slope within a CI, and non-significant intercepts) demonstrating substantial equivalence.

Performance Metric (Regression Analysis vs. Manual Chamber Count)	Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance
RBC (Red Blood Cells)	High R2 (close to 1), Slope close to 1, Non-significant intercept.	R2 = 0.992 (outliers removed), Slope = 0.906, Slope 95% CI: 0.896 - 0.915, Non-zero intercepts were not statistically significant.
Nucleated Cells (NC)	High R2 (close to 1), Slope close to 1, Non-significant intercept.	R2 = 0.967 (outliers removed), Slope = 1.015, Slope 95% CI: 0.993 - 1.037, Non-zero intercepts were not statistically significant.
Linear Response	Demonstrates linearity from 0 to 10,000 particles/microliter.	Demonstrated linear response from 0 to 10,000 particles/microliter according to NCCLS EP6-A protocol.
Mean Difference between Replicate Cell Counts	Not statistically different from zero.	Paired t-tests showed that the mean difference between replicate cell counts was not statistically different from zero.

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

RBC Test Set Sample Size: 304 samples
Nucleated Cells Test Set Sample Size: 299 samples
Data Provenance: Not explicitly stated (e.g., country of origin). The study is presented as a "Clinical Trial," implying prospective data collection, but it's not explicitly labeled as such or as retrospective.

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

The ground truth was established by "manual chamber counting" performed by a "competent human observer." The number of observers is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison is between the device's performance and manual chamber counting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the device's performance to "manual chamber counting," not to human readers' performance with and without AI assistance. The device itself still involves a "competent human observer" to potentially change machine assignments, but the primary performance study focuses on the instrument's accuracy compared to a manual method.

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

The device is explicitly described as being "used by a competent human observer to examine and count red blood cells and nucleated cells" and that "A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported." Therefore, the reported performance is not a standalone (algorithm only) performance, but rather a system performance including the human-in-the-loop for review and potential correction.

7. The Type of Ground Truth Used

The ground truth used was expert manual chamber counting.

8. The Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The focus is on the performance comparison of the device against the manual method.

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

Since no training set information is provided, there is no information on how its ground truth was established.

Summary

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Iris Diagnostics, A Division of IRIS International, Inc.

9172 Eton Avenue, Chatsworth, CA 91311 818-709-1244 FAX 818-700-9661 800-776-4747

510(k) SUMMARY

510(k) Submission: K050235

iQ® 200 Urine Analyzer Body Fluids Module

General Information:

Date of Submission:	January 31, 2005
Trade Name of Device:	iQ® 200 Urine Analyzer Body Fluids Module
Common Name of Device:	Instrument for performing RBC and nucleated cell counts in Cerebrospinal and Serous Body Fluids.
Classification Name:	Automated cell counter, 21CFR 864.5200, Class II device
Submitter's Name:	Harvey L. Kasdan, Ph.D. Chief Scientist Iris Diagnostics, A Division of IRIS International, Inc. 9172 Eton Avenue, Chatsworth, CA 91311
Indications for Use (Brief):	Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses. The iQ® 200 Urine Analyzer Body Fluids Module is used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids.
Intended Use:	The iQ® 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids. This module is a capability added to the iQ200 Urine Analyzer, a cleared urinalysis instrument (K022774).

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Substantial Equivalenceto Predicate Devices:	The iQ®200 Urine Analyzer Body Fluids Module is substantiallyequivalent to Flow Microscopy of Pleural Fluid, Peritoneal Fluidand Peritoneal Dialysate in The Yellow IRIS UrinalysisWorkstation (K914256), Flow Microscopy of Cerebrospinal Fluidand Seminal Fluid in The Yellow IRIS Urinalysis Workstation(K934539), Flow Microscopy of Synovial Fluid and PericardialFluid in The Yellow IRIS Urinalysis Workstation (K954006), andthe Sysmex XE-2100 Series Hematology Analyzer Body FluidApplication (K040073), in its principles and technology, itsautomated functions and the participative involvement of acompetent human observer, as well as to manual body fluidmicroscopic cell-count examination by a competent observer usinga light microscope.
Summary ofTechnologicalCharacteristics:	Two aliquots from each body fluid specimen sample areprepared. One aliquot is diluted in normal saline to provide aconcentration in the linear range of the instrument. The secondaliquot is treated with a lysing reagent to allow unambiguousidentification of nucleated cells by eliminating RBC confusion.Particle images are captured and saved electronically as the sampleflows past a microscope objective at a high speed, electronicallyconcentrating particles. Particle images are then ordered by sizeinto assigned categories on a video display. A competent humanobserver may change machine assignments, after which particleconcentrations are recomputed and reported.
Performance Studies:	Microscopic cell counting performance of the iQ® 200 AnalyzerBody Fluids Module was compared with manual chambercounting.
Conclusions DrawnFrom Clinical Tests:	Clinical trial performance data demonstrated that the iQ® 200Analyzer Body Fluids Module is substantially equivalent to themanual chamber counting method used for body fluid cell countdetermination. Regression analysis of all iQ®200 Analyzer BodyFluids Module CSF and Serous fluid sample cell counts oncorresponding manual chamber counts yielded the followingresults with outliers removed:
	Cell	Number of Samples	R2	Slope	Slope 95% CI
	RBC	304	0.992	0.906	0.896 - 0.915
	Nucleated Cells (NC)	299	0.967	1.015	0.993 - 1.037

(RBC R2 = 0.973 and NC R2 = 0.940 with outliers.)

Non-zero intercepts were not statistically significant. Similar results were obtained for CSF and Serous Fluid alone. Paired ttests showed that the mean difference between replicate cell counts was not statistically different from zero. NCCLS EP6-A protocol demonstrated linear response from 0 to 10,000 particles/microliter.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 3 2005

Harvey L. Kasdan, Ph.D. Chief Scientist Iris Diagnostics Division of IRIS International, Inc. 9172 Eton Avenue Chatsworth, California 91311

Re:

K050235 Trade/Device Name: iQ® 200 Urine Analyzer Body Fluids Module Regulation Number: 21 CFR § 864.5200 Regulation Name: Automated Cell Counter Regulatory Class: II Product Code: GKL Dated: January 31, 2005 Received: February 1, 2005

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 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). 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.

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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,

lobetz Beckerh

Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology 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): K050235

Device Name: iQ® 200 Urine Analyzer Body Fluids Module

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 807 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)
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Stephanie Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K050233

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).