(64 days)
Sysmex UF-100TM
Not Found
No
The summary describes a flow cytometry-based analyzer and does not mention AI, ML, or image processing. The performance studies focus on correlation with a predicate device, not AI/ML model performance.
No
This device is an in vitro diagnostic device used in clinical laboratories for analyzing urine samples, not for providing direct therapeutic treatment.
Yes
Explanation: The device is described as a "fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory." It "replaces microscopic review of normal/abnormal specimens and flags specimens containing certain abnormalities which indicate the need for further testing." This clearly indicates its role in diagnosing conditions by analyzing urine samples.
No
The device description explicitly states it is a "fully automated urine cell analyzer" that uses "flow cytometry technology," indicating it is a hardware device with integrated software, not a software-only device.
Yes, the Sysmex UF-50 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states: "The Sysmex UF-50 is a fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory."
- Device Description: It describes the device as a "fully automated urine cell analyzer for urinalysis in clinical laboratories," which aligns with the purpose of an IVD device used for testing biological samples (urine) outside of the body.
- Intended User / Care Setting: It specifies the intended users as "clinical laboratory / Laboratorians," which are the typical users of IVD devices.
The document clearly and repeatedly indicates that the device is intended for diagnostic use on samples taken from the body (in vitro).
N/A
Intended Use / Indications for Use
The UF-50 is intended for in vitro diagnostic use in urinalysis in clinical laboratories. The instrument is a medical device which flags specimens containing certain abnormalities. Laboratorians are responsible for final microscopic review of abnormalities.
The Sysmex UF-50 is a fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory. The UF-50 replaces microscopic review of normal/abnormal specimens and flags specimens containing certain abnormalities which indicate the need for further testing. Laboratorians are responsible for final microscopic review of flagged abnormalities.
Product codes
LKM, GKZ
Device Description
The UF-50 is a fully automated urine cell analyzer for urinalysis in clinical laboratories. It analyzes formed elements in urine using flow cytometry technology.
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
Laboratorians / clinical laboratories
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
Not Found
Summary of Performance Studies
Correlation studies were performed to evaluate the equivalency of the UF-50 performance compared to the predicate device, the UF-100. The comparison results performance ochipated to mapce of the two analyzers, therefore supporting the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Sysmex UF-100TM
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
Image /page/0/Picture/1 description: The image shows the word "Sysmex" in a stylized, double-lined font. The letters are bold and black, and the word is followed by the superscript letters "TM". The logo appears to be a company logo. The font is sans-serif.
SYSMEX CORPORATION GILMER ROAD 6699RFD Long Grove, IL 60047-9596 (800) 379-7639 (847) 726-3505 Facsimile
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is _KO12372
Submitted By: 1.
Chris Stukel
Sysmex Corporation of America Gilmer Road, 6699 RFD Long Grove, IL 60047 1-847-726-3523 (PHONE) 1-847-726-3559 (FAX) July 25, 2001
Name of Device:
Trade Name- Sysmex UF-50TM
Common Name- Fully Automated Urine Cell Analyzer
Classification Name- Urine Particle Counter
Sysmex UF-100TM
Predicate Device:
Device Description: 4.
The UF-50 is a fully automated urine cell analyzer for urinalysis in clinical laboratories. It analyzes formed elements in urine using flow cytometry technology.
న్. Intended Use:
The UF-50 is intended for in vitro diagnostic use in urinalysis in clinical laboratories. The instrument is a medical device which flags specimens containing certain abnormalities. Laboratorians are responsible for final microscopic review of abnormalities.
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Technology Characteristics: 6.
| UF-50 | UF-100 | |
|---|---|---|
| Flow Cytometry detection | ||
| with Argon laser beam for all | ||
| parameters? | YES | YES |
| Flow Cytometry plus Electric | ||
| impedance detection for three | ||
| parameters? | NO | YES |
Clinical Performance Data: 7.
Correlation studies were performed to evaluate the equivalency of the UF-50 performance compared to the predicate device, the UF-100. The comparison results performance ochipated to mapce of the two analyzers, therefore supporting the claim of substantial equivalence.
Conclusions: 8.
. .
The performance data demonstrated substantial equivalence.
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Chris Stukel, BSMT (ASCP) Regulatory Affairs Specialist Sysmex Corporation Gilmer Road 6699 RFD Long Grove, Illinois 60047-9596
SEP 2 8 2001
K012372 Re:
Trade/Device Name: Sysmex™ UF-50TM Regulation Number: 21 CFR § 864.5200 Regulation Name: Counter, Urine Particle Regulatory Class: II Product Code: LKM, GKZ Dated: July 25, 2001 Received: July 26, 2001
Dear Mr. Stukel:
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
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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 Sutman
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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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known) | K012372 |
|---|---|
| Device Name | Sysmex UF-50™ |
| Indications for Use | The Sysmex UF-50 is a fully automated urine cell analyzer intended for in vitro diagnostic use in urinalysis within the clinical laboratory. The UF-50 replaces microscopic review of normal/abnormal specimens and flags specimens containing certain abnormalities which indicate the need for further testing. Laboratorians are responsible for final microscopic review of flagged abnormalities. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Clinical Laboratory Devices
510(k) Number K012372
Prescription Use_
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
UF-50 510(k) Attachment 4
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