SYSMEX UF-50

K012372 · Sysmex Corp. · LKM · Sep 28, 2001 · Hematology

Device Facts

• Record ID: K012372
• Device Name: SYSMEX UF-50
• Applicant: Sysmex Corp.
• Product Code: LKM · Hematology
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended 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.

Device Story

Fully automated urine cell analyzer; utilizes flow cytometry with argon laser beam to analyze formed elements in urine. Operates in clinical laboratory settings; managed by laboratory personnel. Device flags specimens with abnormalities; alerts laboratorians to perform final microscopic review. Output assists in clinical decision-making by streamlining urinalysis workflow and identifying samples requiring manual inspection. Benefits include increased efficiency in laboratory testing and standardized screening of urine specimens.

Clinical Evidence

Correlation studies performed comparing UF-50 performance to the predicate UF-100. Results indicated equivalent performance between the two analyzers.

Technological Characteristics

Fully automated urine cell analyzer. Detection principle: Flow cytometry using an argon laser beam. Unlike the predicate UF-100, the UF-50 does not utilize electric impedance detection for three parameters.

Indications for Use

Indicated for in vitro diagnostic urinalysis in clinical laboratories. Used to analyze urine specimens, flag abnormalities, and assist laboratorians in determining the need for further microscopic review.

Regulatory Classification

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.

Predicate Devices

• Sysmex UF-100 (K012372)

Submission Summary (Full Text)

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SYSMEX CORPORATION GILMER ROAD 6699RFD Long Grove, IL 60047-9596 [phone] [phone] 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

2.

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:

3.

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<br>with Argon laser beam for all<br>parameters? | YES | YES |
| Flow Cytometry plus Electric<br>impedance detection for three<br>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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 <i>in vitro</i> 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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