(50 days)
No
The device description mentions image capture and ordering by size, but explicitly states that a "competent human observer may change machine assignments," indicating a rule-based or algorithmic approach rather than AI/ML for final classification. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML models.
No.
Explanation: The device is an in-vitro diagnostic device used to examine and count cells in body fluids for diagnostic purposes, not to provide therapy.
Yes
The document explicitly states in the "Intended Use / Indications for Use" section that the device "is an in-vitro diagnostic device." It also describes its use in diagnosing various conditions by analyzing body fluids.
No
The device description explicitly mentions hardware components like a microscope objective and a system for flowing the sample, 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 device is an "in-vitro diagnostic device".
- Purpose: It is used to examine and count cells in body fluids (cerebrospinal fluid and serous fluids) to assist physicians in diagnosing various medical conditions. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Specimen Type: The device analyzes body fluids, which are specimens derived from the human body.
- Diagnostic Information: The information produced (cell concentrations) is used as part of a larger body of laboratory and other test results to assist physicians in health assessments or differential diagnoses.
The description clearly indicates that the device is used in vitro (outside the body) to analyze human specimens for diagnostic purposes.
N/A
Intended Use / Indications for 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.
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.
Product codes
GKL
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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cerebrospinal fluid, Serous fluids
Indicated Patient Age Range
Not Found
Intended User / Care Setting
competent human observer
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Microscopic cell counting performance of the iQ® 200 Analyzer Body Fluids Module was compared with manual chamber counting.
Clinical trial performance data demonstrated that the iQ® 200 Analyzer Body Fluids Module is substantially equivalent to the manual chamber counting method used for body fluid cell count determination. Regression analysis of all iQ®200 Analyzer Body Fluids Module CSF and Serous fluid sample cell counts on corresponding manual chamber counts yielded the following results with outliers removed:
RBC: Number of Samples 304, R2 0.992, Slope 0.906, Slope 95% CI 0.896 - 0.915
Nucleated Cells (NC): Number of Samples 299, R2 0.967, Slope 1.015, Slope 95% CI 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 t-tests 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.
Key Metrics
R2, Slope, Slope 95% CI, Linear response from 0 to 10,000 particles/microliter, mean difference between replicate cell counts
Predicate Device(s)
K914256, K934539, K954006, K040073
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Equivalence
to Predicate Devices: | The iQ®200 Urine Analyzer Body Fluids Module is substantially
equivalent to Flow Microscopy of Pleural Fluid, Peritoneal Fluid
and Peritoneal Dialysate in The Yellow IRIS Urinalysis
Workstation (K914256), Flow Microscopy of Cerebrospinal Fluid
and Seminal Fluid in The Yellow IRIS Urinalysis Workstation
(K934539), Flow Microscopy of Synovial Fluid and Pericardial
Fluid in The Yellow IRIS Urinalysis Workstation (K954006), and
the Sysmex XE-2100 Series Hematology Analyzer Body Fluid
Application (K040073), in its principles and technology, its
automated functions and the participative involvement of a
competent human observer, as well as to manual body fluid
microscopic cell-count examination by a competent observer using
a light microscope. | | | | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-------|-------|---------------|
| Summary of
Technological
Characteristics: | 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. | | | | |
| Performance Studies: | Microscopic cell counting performance of the iQ® 200 Analyzer
Body Fluids Module was compared with manual chamber
counting. | | | | |
| Conclusions Drawn
From Clinical Tests: | Clinical trial performance data demonstrated that the iQ® 200
Analyzer Body Fluids Module is substantially equivalent to the
manual chamber counting method used for body fluid cell count
determination. Regression analysis of all iQ®200 Analyzer Body
Fluids Module CSF and Serous fluid sample cell counts on
corresponding manual chamber counts yielded the following
results 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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Page 2 -
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
4
Indications for Use
510(k) Number (if known): K050235
Device Name: iQ® 200 Urine Analyzer Body Fluids Module
Indications for 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.
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.
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) | |
|---|---|
| -- | ------------------------------------------------------------------- |
Stephanie Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
510(k) K050233