(57 days)
UF-100
Not Found
No
The description focuses on laser flow cytometry and impedance principles, and there is no mention of AI, ML, or image processing.
No
This device is for in vitro diagnostic use, analyzing urine parameters to screen patient populations in clinical laboratories, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is described as an "automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories." It analyzes various parameters in urine samples, which is a diagnostic function.
No
The device description explicitly states it is an "automated urine cell analyzer" that uses "Laser Flow Cytometry and Impedance," which are hardware-based technologies for analyzing urine samples. It also mentions being a "dedicated system" and attaching to a "commercially available reagent strip reader," further indicating it is a physical device with hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."
This statement clearly indicates that the device is intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-100i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell.
Product codes
LKM
Device Description
The Sysmex® UF-100i, automated urine cell analyzer is a dedicated system for the analysis of microscopic formed elements in urine specimens. It accomplishes this by the principles of Laser Flow Cytometry and Impedance. The UF-100i attached to a commercially available reagent strip reader provides all that is required to perform an automated urinalysis profile consisting of chemistries and microscopic results.
Mentions image processing
Not Found
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
in clinical laboratories.
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
Accuracy: Comparison to the UF-100 demonstrated excellent correlation.
Key Metrics
Not Found
Predicate Device(s)
UF-100
Reference Device(s)
Not Found
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
JAN 4 2006
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 053135
| 1. Submitted by: | Sysmex America, Inc.
One Nelson C. White Parkway
Mundelein, IL 60060
Phone: (847) 996-4675; FAX: (847) 996-4655
Contact person: Nina Gamperling
Date prepared: November 4, 2005 |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® Automated Urine Cell
Analyzer, UF-100i |
| | Common name: Automated Urine Cell Analyzer. |
| | Classification name: Sysmex® UF-100i, Automated Urine Cell
Analyzer, is a Urine Particle Counter (21 CFR 864.5200) is a
Class II medical device. |
| 3. Predicate Method: | The Sysmex® UF-100i claims substantial equivalence to the UF-
100, the predicate method. |
| 4. Device Description: | The Sysmex® UF-100i, automated urine cell analyzer is a
dedicated system for the analysis of microscopic formed elements
in urine specimens. It accomplishes this by the principles of
Laser Flow Cytometry and Impedance. The UF-100i attached to
a commercially available reagent strip reader provides all that is
required to perform an automated urinalysis profile consisting of
chemistries and microscopic results. |
| 5. Intended Use: | The Sysmex® UF-100i is an automated urine cell analyzer for in
vitro diagnostic use in screening patient populations found in
clinical laboratories. The UF-100i analyzes the following
parameters in urine samples: RBC, WBC, Epithelial Cells, Cast,
and Bacteria and flags the presence of the following: Pathologic
Cast, Crystal, Sperm, Small Round Cell, Yeast like cell. |
| 6. Substantial
equivalence-similarities
and differences: | The following table compares the UF-100i with the UF-100, the
predicate method. |
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Sysmex UF-100 | Sysmex UF-100i | |
|---|---|---|
| Predicate | Modification of Predicate | |
| Intended Use | The SysmexTM UF-100 is intended for | |
| in vitro diagnostic use in clinical | ||
| laboratories. The UF-100 analyzes the | ||
| following parameters: RBC, WBC, | ||
| Epithelial Cells, Cast, and Bacteria | ||
| and flags the presence of the | ||
| following: Pathologic Cast, Crystal, | ||
| Yeast like cell, Sperm and Small | ||
| Round Cell. | The Sysmex® UF-100i is an | |
| automated urine cell analyzer for | ||
| in vitro diagnostic use in screening | ||
| patient populations found in | ||
| clinical laboratories. The UF-100i | ||
| analyzes the following parameters | ||
| in urine samples: RBC, WBC, | ||
| Epithelial Cells, Cast, and Bacteria | ||
| and flags the presence of the | ||
| following: Pathologic Cast, Crystal, | ||
| Sperm, Small Round Cell, Yeast like | ||
| cell. | ||
| Methodology | The UF-100 uses the technique of | |
| flow cytometry measuring forward | ||
| scatter and fluorescence and | ||
| impedance. | The UF-100i uses the same | |
| methodology as the UF-100. | ||
| Reagents | URINOSHEATH | |
| URINOSEARCH | ||
| URINOPACK | The UF-100i uses the same reagents | |
| as the UF-100. | ||
| Software/ | ||
| Hardware | ||
| Differences | --- | New front upper cover and hinge, no |
| laser transformer, screen and labeling | ||
| changes. | ||
| Specimen Type | Random urine sample | Same as UF-100 |
| Accuracy | Performance was established in the | |
| previous 510(k) submission. | Comparison to the UF-100 | |
| demonstrated excellent correlation. |
Comparison Table to Predicate Method
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
JAN 4 2006
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nina M. Gamperling Manager, Regulatory Affairs Sysmex American, Inc. One Nelson C. White Parkway Mundelein, IL 60060
Re: K053135
Trade/Device Name: Sysmex® UF-100i, Automated Urine Cell Analyzer Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: November 04, 2005 Received: November 08, 2005
Dear Ms. Gamperling:
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,
lobatz 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 STATEMENT
K053135 510(k) Number (if known):
Device Name: Sysmex® UF-100i, Automated Urine Cell Analyzer
Indications For Use:
The Sysmex® UF-100i is an automated urine cell analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-100i analyzes the following parameters in urine samples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags the presence of the following: Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast like cell.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CHRD, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
Robert L. Beckerf
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety 11
Sysmex UF-100i, Automated Urine Cell Analyzer
510(k) FDA Submission
510(k)