(462 days)
No
The description explicitly states that a "competent human observer" makes the final assignments and can change machine assignments, indicating the primary decision-making is human-driven, not AI/ML. While image processing is mentioned, there is no indication of AI/ML being used for classification or analysis.
No
The device is described as an "in-vitro diagnostic device" used to "examine and count red blood cells and nucleated cells" in various body fluids, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device".
No
The device is described as a "module" for an existing "Urine Analyzer" which is a hardware device. The description mentions capturing images using a "microscope objective" and processing samples as they "flow past," indicating a physical component involved in sample analysis. While it includes software for image processing and display, it is not solely software.
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".
- Sample Type: The device is used to examine and count cells in various body fluids (cerebrospinal fluid, serous fluids, and synovial fluid), which are samples taken from the body but analyzed outside the body. This is a key characteristic of in vitro diagnostics.
- Purpose: The purpose is to provide information about the composition of these body fluids, which is used for diagnostic purposes by trained laboratory users.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GKL
Device Description
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).
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained laboratory user
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Performance / Equivalency Data: Data consisting of Accuracy, Precision, Linearity and Carryover was collected to show performance to the manufacturer's specification for the Body Fluid mode. This analysis supports the claim that the synovial capability in the iQ®200 Urine Analyzer Body Fluids Module is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
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 Avenue
Chatsworth, CA 91311.
Phone: 818.527-7264
Contact person: David W. Gates
Vice-President Quality Assurance and Regulatory
Affairs
david.gates@proiris.com |
|----|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Name of Device: | Addition of Synovial Fluid Cell Count parameter to
iQ® 200 Urine Analyzer Body Fluids Module
Common Name: Instrument for performing RBC and
nucleated cell (WBC and other as a group) counts in
Synovial Fluid.
Classification Name: Automated cell counter, 21 CFR
864.5200, Class II device, Product Code GKL |
| 3. | Predicate Methods: | Iris Diagnostics believes the addition of synovial fluids
to the iQ®200 Urine Analyzer Body Fluids Module is
substantially equivalent to the Sysmex® XT-4000i,
cleared Mar 30, 2010 under K091313. |
| 4. | Device Description: | 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 |
The iQ®200 Urine Analyzer Body Fluids Module Synovial Fluid Parameter
1
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 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.
-
- Substantial equivalence Table 1 shows substantial equivalence of the - Similarities and proposed synovial fluid parameter to the cleared Differences: predicate.
-
- 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.
2
Table 1: Substantial Equivalence – Similarities and Difference to predicate devices
| Characteristic | iQ200 Urine Analyzer Body Fluid module
with Synovial Fluid Parameter | Predicate Device
Sysmex® XT-4000i,
K091313. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | New Parameter | Similarity/
Differences |
| Intended 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. | The Sysmex® XT-4000i is a quantitative multi-parameter automated
hematology analyzer intended for in vitro diagnostic use in screening
patient populations found in clinical laboratories. The XT-4000i
classifies 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 for
body 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. Serous
and Synovial fluids should be collected in K2EDTA to prevent clotting
of fluid. The use of anticoagulants with CSF specimens is not required
or recommended. |
| Methodology | Hyaluronidase is added to the specimen,
mixed and incubated. 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 agent to allow
unambiguous identification of WBC and other
nucleated cells by eliminating RBC. 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 | Performs hematology according to the Hydro Dynamic Focusing (DC
Detection), flow cytometry method (using a semiconductor laser), and
SLS-hemoglobin laser). |
| Parameters Tested | | |
| | concentrations are recomputed and reported
iQ®200 Urine Analyzer Body Fluids Module
with synovial fluid capability enumerates red
blood cells and nucleated cells in synovial
fluid. | 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 collected
using K2EDTA as an anti-coagulant. | Synovial fluids should be collected in K2EDTA to prevent clotting of
fluid. |
| Reagents /
Consumables | Body Fluids specific consumables:
- Hyaluronidase (not
supplied by Iris
Diagnostics) - iQ®Body Fluids Control -
Two levels - iQ® Body Fluids Lysing
Reagent | 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 Levels
Calibrator (X Cal) |
| Software /
Hardware | The iQ®200 Urine Analyzer Body Fluids
Module software added Synovial Fluid
capability | The XT-4000i performs the same as the XT-2000i and has a Body
fluid mode the same as the XE-5000 |
| Specimen Types | Cerebrospinal fluid, serous fluids and
synovial fluid | Whole blood, cerebrospinal fluid, serous fluids and synovial fluid |
| Performance /
Equivalency
Data | Data consisting of Accuracy, Precision,
Linearity and Carryover was collected to
show performance to the manufacturer's
specification for the Body Fluid mode. This
analysis supports the claim that the synovial
capability in the iQ®200 Urine Analyzer Body
Fluids Module is substantially equivalent to
the predicate. | Data consisting of Accuracy, Precision, Linearity and Carryover was
collected to show performance to the manufacturer's specification
for 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
v-3
3
The iQ®200 Urine Analyzer Body Fluids Module
Synovial Fluid Parameter
v-4
4
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
5
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
6
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