(462 days)
The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ®200 Urine Analyzer.
The iQ®200 Urine Analyzer Body Fluids Module for use with synovial fluid is an additional use for the iQ®200 Urine Analyzer (K022774 – cleared October 21, 2002). It is used by a competent human observer to examine and count red blood cells and nucleated cells in synovial fluid and is an added body fluid to the previously cleared iQ®200 Urine Analyzer Body Fluids Module cerebrospinal and serous fluids (K050235 -Cleared March 23, 2005).
The provided text describes the 510(k) submission for the iQ® 200 Urine Analyzer Body Fluids Module with the addition of Synovial Fluid capability. It compares the device to a predicate device, the Sysmex® XT-4000i. However, the document does not provide a table of acceptance criteria or the specific performance data against those criteria. It states that "Clinical trial performance data demonstrated that the Synovial Fluid parameter on the iQ®200 Urine Analyzer Body Fluids Module is substantially equivalent to its predicates," and that "Data consisting of Accuracy, Precision, Linearity and Carryover was collected to show performance to the manufacturer's specification for the Body Fluid mode." However, these specific data points and the defined acceptance criteria are not included in the provided text.
Therefore, I can only address parts of your request based on the available information.
Summary of Available Information:
The iQ® 200 Urine Analyzer Body Fluids Module, with the new Synovial Fluid parameter, is an in-vitro diagnostic device used by trained laboratory users to examine and count red blood cells and nucleated cells in synovial fluid (along with cerebrospinal and serous fluids). It operates by adding hyaluronidase to the specimen, preparing two aliquots (one diluted, one lysed), capturing particle images as the sample flows past a microscope objective, ordering images by size into categories, and allowing a human observer to change machine assignments before re-computing and reporting concentrations.
The device's substantial equivalence to the Sysmex® XT-4000i (K091313) is claimed based on similarities in intended use, specimen collection (K2EDTA for synovial fluid), and the fact that both devices collect data on Accuracy, Precision, Linearity, and Carryover to demonstrate performance to manufacturer's specifications.
Information NOT available in the provided text:
- Specific Acceptance Criteria: The document mentions that performance data was collected "to show performance to the manufacturer's specification," but it does not specify what those specifications or acceptance criteria are (e.g., minimum accuracy percentages, precision ranges, linearity R-squared values, etc.).
- Reported Device Performance (against specific criteria): While the document states that clinical trial data "demonstrated substantial equivalence," the actual performance values for Accuracy, Precision, Linearity, and Carryover for the iQ® 200 Synovial Fluid module are not provided.
- Sample size used for the test set and data provenance: The document mentions "clinical trial performance data" and "Data consisting of Accuracy, Precision, Linearity and Carryover was collected," but it does not specify the sample size of the test set, the country of origin of the data, or whether it was retrospective or prospective.
- Number of experts and their qualifications for ground truth: This information is not provided.
- Adjudication method for the test set: This information is not provided.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: The document does not describe an MRMC study. The device is used by a "competent human observer" who "may change machine assignments," indicating a human-in-the-loop process, but no comparative effectiveness study with and without AI assistance is described.
- Standalone (algorithm-only) performance: The device description clearly states that a "competent human observer may change machine assignments, after which particle concentrations are recomputed and reported," indicating it's not a standalone device. Therefore, standalone performance data would not be applicable or provided.
- Type of ground truth used: Given the context of a cell counter, it's highly likely that ground truth for performance studies would be established by manual microscopy with expert review, but this is not explicitly stated in the document.
- Sample size for the training set: The document does not mention any training set for an algorithm, as it describes a device that captures images and categorizes them, with human oversight. This suggests a more rule-based or image processing approach rather than a machine learning model requiring a distinct training set.
- How the ground truth for the training set was established: As no training set is described, this information is not applicable.
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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
AUG 3 1 2010
510(k) SUMMARY
510(k) Submission: K091539
iQ® 200 Urine Analyzer Body Fluids Module (The addition of Synovial Fluid)
| 1. | Submitted by: | Iris Diagnostics, a Division of IRIS International, Inc.9172 Eton AvenueChatsworth, CA 91311.Phone: 818.527-7264Contact person: David W. GatesVice-President Quality Assurance and RegulatoryAffairsdavid.gates@proiris.com |
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| 2. | Name of Device: | Addition of Synovial Fluid Cell Count parameter toiQ® 200 Urine Analyzer Body Fluids ModuleCommon Name: Instrument for performing RBC andnucleated cell (WBC and other as a group) counts inSynovial Fluid.Classification Name: Automated cell counter, 21 CFR864.5200, Class II device, Product Code GKL |
| 3. | Predicate Methods: | Iris Diagnostics believes the addition of synovial fluidsto the iQ®200 Urine Analyzer Body Fluids Module issubstantially equivalent to the Sysmex® XT-4000i,cleared Mar 30, 2010 under K091313. |
| 4. | Device Description: | The iQ®200 Urine Analyzer Body Fluids Module foruse with synovial fluid is an additional use for theiQ®200 Urine Analyzer (K022774 – cleared October21, 2002). It is used by a competent human observerto examine and count red blood cells and nucleated |
The iQ®200 Urine Analyzer Body Fluids Module Synovial Fluid Parameter
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cells in synovial fluid and is an added body fluid to the previously cleared iQ®200 Urine Analyzer Body Fluids Module cerebrospinal and serous fluids (K050235 -Cleared March 23, 2005).
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- The iQ®200 Urine Analyzer Body Fluids Module is an Intended Use: in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ 200 Urine Analyzer.
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- Substantial equivalence Table 1 shows substantial equivalence of the - Similarities and proposed synovial fluid parameter to the cleared Differences: predicate.
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- Conclusion: Clinical trial performance data demonstrated that the Synovial Fluid parameter on the iQ@200 Urine Analyzer Body Fluids Module is substantially equivalent to its predicates.
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Table 1: Substantial Equivalence – Similarities and Difference to predicate devices
| Characteristic | iQ200 Urine Analyzer Body Fluid modulewith Synovial Fluid Parameter | Predicate DeviceSysmex® XT-4000i,K091313. |
|---|---|---|
| New Parameter | Similarity/Differences | |
| Intended Use | The iQ®200 Urine Analyzer Body FluidsModule is an in-vitro diagnostic device usedby an appropriately trained laboratory user toexamine and count red blood cells andnucleated cells in cerebrospinal fluid, serousfluids and synovial fluid. This module is acapability added to the iQ®200 UrineAnalyzer. | The Sysmex® XT-4000i is a quantitative multi-parameter automatedhematology analyzer intended for in vitro diagnostic use in screeningpatient populations found in clinical laboratories. The XT-4000iclassifies and enumerates the following parameters for whole blood:WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEU%#,LYMPH%/#, MONO%/#, E0 %/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MP-V, RETP%/#, IRF, RET-He and has a Body Fluid- mode forbody fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF,MN%/#, PMN%/# and TC-BF# parameters in cerebrospinal fluids(CSF), serous fluids (peritoneal, pleural) and synovial fluids. Serousand Synovial fluids should be collected in K2EDTA to prevent clottingof fluid. The use of anticoagulants with CSF specimens is not requiredor recommended. |
| Methodology | Hyaluronidase is added to the specimen,mixed and incubated. Two aliquots fromeach body fluid specimen sample areprepared. One aliquot is diluted in normalsaline to provide a concentration in the linearrange of the instrument. The second aliquotis treated with a lysing agent to allowunambiguous identification of WBC and othernucleated cells by eliminating RBC. Particleimages are captured and saved electronicallyas the sample flows past a microscopeobjective at a high speed, electronicallyconcentrating particles. Particle images arethen ordered by size into assignedcategories on a video display. A competenthuman observer may change machineassignments, after which particle | Performs hematology according to the Hydro Dynamic Focusing (DCDetection), flow cytometry method (using a semiconductor laser), andSLS-hemoglobin laser). |
| Parameters Tested | ||
| concentrations are recomputed and reportediQ®200 Urine Analyzer Body Fluids Modulewith synovial fluid capability enumerates redblood cells and nucleated cells in synovialfluid. | The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#,PMN%/# and TC-BF# parameters in cerebrospinal fluids (CSF),serous fluids (peritoneal, pleural) and synovial fluids. | |
| Specimen Collection | Synovial specimens should be collectedusing K2EDTA as an anti-coagulant. | Synovial fluids should be collected in K2EDTA to prevent clotting offluid. |
| Reagents /Consumables | Body Fluids specific consumables:- Hyaluronidase (notsupplied by IrisDiagnostics)- iQ®Body Fluids Control -Two levels- iQ® Body Fluids LysingReagent | CELLPACKTM (Diluent),STROMATOLYSERTM- FB (Lyse), STROMATOLYSER-4DLTM (Lyse)STROMATOLYSER-4DSTM (Stain)SULFOLYSER (Lyse)RET-SEARCH II (Diluent)RET-SEARCH (Stain) |
| Calibrator /Quality Control | - iQ®Calibrator Pack- iQ®Control/Focus Set- iQ®Body Fluids Control -Two levels | c-Check (XE) - 3 LevelsCalibrator (X Cal) |
| Software /Hardware | The iQ®200 Urine Analyzer Body FluidsModule software added Synovial Fluidcapability | The XT-4000i performs the same as the XT-2000i and has a Bodyfluid mode the same as the XE-5000 |
| Specimen Types | Cerebrospinal fluid, serous fluids andsynovial fluid | Whole blood, cerebrospinal fluid, serous fluids and synovial fluid |
| Performance /EquivalencyData | Data consisting of Accuracy, Precision,Linearity and Carryover was collected toshow performance to the manufacturer'sspecification for the Body Fluid mode. Thisanalysis supports the claim that the synovialcapability in the iQ®200 Urine Analyzer BodyFluids Module is substantially equivalent tothe predicate. | Data consisting of Accuracy, Precision, Linearity and Carryover wascollected to show performance to the manufacturer's specificationfor the Body Fluid mode. This analysis supports the claim that the XT-4000i Body Fluid mode is substantially equivalent to the XE-5000 |
The iQ®200 Urine Analyzer Body Fluids Module
Synovial Fluid Parameter
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The iQ®200 Urine Analyzer Body Fluids Module
Synovial Fluid Parameter
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Image /page/4/Picture/1 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 forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Iris Diagnostics c/o Mr. William M. Dougherty Director, Clinical Evaluations 9172 Eton Avenue Chatsworth, CA 91311
AUG 3 1 2010
Re: K091539
Trade/Device Name: iQ® 200 Urine Analyzer Body Fluids Module Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: GKL Dated: August 17, 2010 Received: August 19, 2010
Dear Mr. Dougherty:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
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Page 2 - Mr. William M. Dougherty
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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
mchan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
AUG 3 1 2010
510(k) Number (if known): K091539
Device Name: iQ 200 Urine Analyzer Body Fluids Module (Addition of Synovial Fluids)
Indications For Use: The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ®200 Urine Analyzer.
Prescription Use X (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
office of In Vitro Diagn
510(k) K091539
§ 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).