(61 days)
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Unknown
The document mentions an "auto analyte recognition algorithm" for image analysis and classification, which could potentially be implemented using AI/ML techniques, but it does not explicitly state that AI or ML is used. The description lacks details about the algorithm's nature, training data, or performance metrics typically associated with AI/ML models.
No.
This device is an in-vitro diagnostic device used to analyze urine, providing information that aids physicians in health assessments or differential diagnoses. It is not designed to treat or alleviate diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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." It further elaborates on its use in screening, diagnosis, and monitoring of diseases, all of which fall under the scope of diagnostic devices.
No
The device description explicitly mentions hardware components like an autosampler and an independent Computer WorkStation, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the iQ 200 System is an "in-vitro diagnostic device used to automate the complete urinalysis profile".
- Analysis of Biological Specimens: The device analyzes urine, which is a biological specimen.
- Purpose of Analysis: The analysis is performed to provide information about the patient's health status, including the detection of potential diseases or dysfunction. This information is used by physicians for diagnosis and monitoring.
- Laboratory Setting: The device is intended for use in a laboratory setting by trained technologists.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LKM, KQO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Microscopic analysis performance of the iQ 200 System were compared with that of 939UDx Urine Pathology System and the Sysmex UF-100.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical sensitivity (fraction of abnormal specimens detected) of the iQ 200 System exceeded that of the 939UDx Urine Pathology System and Sysmex UF-100, while clinical specificity (fraction of normal specimens detected) was comparable. The iQ 200 System generally had greater sensitivity for detection of individual microscopic formed elements than either the 939UDx Urine Pathology System or the Sysmex UF-100. With sensitivity for detection of each microscopic formed element fixed at 90%, iQ 200 System specificity was greater than that of either the 939UDx Urine Pathology System or Sysmex UF-100 for most formed elements. iQ 200 System automatically reported concentrations of RBC, WBC, squamous epithelial cells and casts 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. The iQ 200 System has been shown to be suitable for its intended use.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Yellow IRIS® Urinalysis Workstation with CHEMSTRIP® Reader, the IRIS Flow Microscope, the 900UDx Urine Pathology System, the 939UDx Urine Pathology System, and the Sysmex UF-100.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 I | |
| Microscope, 21 CFR 862.3600, Class I | |
| Automated cell counter (Urine particle counter), | |
| 21 CFR 864.5200, Class II | |
| Submitter's Name: | Harvey L. Kasdan, Ph.D. |
| Chief Scientist | |
| Iris Diagnostics, A Division of | |
| International 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 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. | |
| Substantial Equivalence | |
| to Predicate Devices: | The iQ 200 System is substantially equivalent under |
| Section 510(k) of the Food, Drug, and Cosmetic Act to The | |
| Yellow IRIS® Urinalysis Workstation with CHEMSTRIP® | |
| Reader, the IRIS Flow Microscope, the 900UDx Urine | |
| Pathology System, the 939UDx Urine Pathology System, and | |
| the Sysmex UF-100. | |
| Summary of | |
| Technological | |
| Characteristics: | 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. | |
| Performance Studies: | Microscopic analysis performance of the iQ 200 System were |
| compared with that of 939UDx Urine Pathology System and | |
| the Sysmex UF-100. | |
| Conclusions Drawn | |
| From Clinical Tests: | Clinical sensitivity (fraction of abnormal specimens detected) |
| of the iQ 200 System exceeded that of the 939UDx Urine | |
| Pathology System and Sysmex UF-100, while clinical | |
| specificity (fraction of normal specimens detected) was | |
| comparable. The iQ 200 System generally had greater | |
| sensitivity for detection of individual microscopic formed | |
| elements than either the 939UDx Urine Pathology System or | |
| the Sysmex UF-100. With sensitivity for detection of each | |
| microscopic formed element fixed at 90%, iQ 200 System | |
| specificity was greater than that of either the 939UDx Urine | |
| Pathology System or Sysmex UF-100 for most formed | |
| elements. iQ 200 System automatically reported | |
| concentrations of RBC, WBC, squamous epithelial cells and | |
| casts 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. The iQ 200 | |
| System has been shown to be suitable for its intended use. |
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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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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.
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.
Caroline Richter
(Division Sign-Off) Division of Clinical Laboratory Devices 510kj Number