(32 days)
Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i 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 and Mucus.
The Sysmex® UF-1000i, an automated urine particle analyzer, is a dedicated system for the analysis of microscopic formed elements in urine specimens. The instrument consists for three principal units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples; (2) Auto Sampler Unit supplies samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automated sampling for up to 50 tubes.
The instrument utilizes Sysmex flow cytometry using a red semiconductor laser for analyzing organized elements of urine. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using its own reagents, the UF-1000i automatically classifies organized elements of urine and carries out all processes automatically from aspiration of the sample to outputting the results.
Analysis results and graphics are displayed on the IPU screen. They can be printed on any of the available printers or transmitted to a Host computer.
The provided text is a 510(k) summary for the Sysmex® UF-1000i with Urinalysis WAM. It details the device, its intended use, and substantial equivalence to a predicate device, but it does not contain detailed information about acceptance criteria or specific studies proving device performance against such criteria for the Urinalysis WAM software.
The key assertion made in the document is about the substantial equivalence of the modified device (UF-1000i with Urinalysis WAM) to the predicate device (UF-1000i without Urinalysis WAM). The document states: "Design validation studies were completed and sample integrity study was performed. and there is no difference between the UF-1000i and the UF-1000i with Urinalysis WAM software." and "The UF-1000i with Urinalysis WAM software demonstrates substantial equivalence to the UF-1000i without the Urinalysis WAM software."
Therefore, the provided text does not offer the specific granular details (acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) that would typically be found in a detailed study report demonstrating performance against acceptance criteria for a new device or a significant modification.
Based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and a study proving the device meets them because this specific detail is not present. The document focuses solely on asserting substantial equivalence through a modification that is stated to have "no difference" in how the core analytical function performs.
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510(k) SUMMARY of the UF-1000i with Urinalysis WAM
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: K# 080889
| 1. Submitted by: | Sysmex America, Inc.One Nelson C. White ParkwayMundelein, IL 60060Phone: (847) 996-4675; FAX: (847) 996-4655Contact person: Nina GamperlingDate prepared: March 28, 2008 |
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| 2. Name of Device: | Trade or proprietary name: Sysmex® UF-1000i with Urinalysis WAMCommon name: Automated urine particle analyzer.Classification name:Urine Particle Counter (21 CFR 864.5200, Product Code LKM)Related Items:Sheath: UFII SHEATH (Product code: GIF)Stain: UFII SEARCH -SED (Product code: GJH)Diluent: UFII PACK -SED (Product code: GIF)Stain: UFII SEARCH -BAC (Product code: GJH)Diluent: UFII PACK -BAC (Product code: GIF)QC Material: UFII CONTROL (Product code: JIW)Calibrator: UFII CALIBRATOR (Product code: JJW)Option:Graph printerBar code ReaderRack Sampler Unit (UASU-3/UASU-4)PU-17Urinalysis WAM software |
| 3. Predicate Method: | Sysmex® UF-1000i (K#070910-Cleared May 25, 2007) |
| 4. Device Descriptionand Methodology: | The Sysmex® UF-1000i, an automated urine particle analyzer, is adedicated system for the analysis of microscopic formed elements inurine specimens. The instrument consists for three principal units: (1)Main Unit which aspirates, dilutes, mixes and analyzes urine samples;(2) Auto Sampler Unit supplies samples to the Main Unit automatically;(3) IPU (Information Processing Unit) which processes data from theMain Unit and provides the operator interface with the system. The UF-1000i is equipped with a Sampler that provides continuous automatedsampling for up to 50 tubes.The instrument utilizes Sysmex flow cytometry using a redsemiconductor laser for analyzing organized elements of urine. Particlecharacterization and identification is based on detection of forwardscatter, fluorescence and adaptive cluster analysis. Using its ownreagents, the UF-1000i automatically classifies organized elements ofurine and carries out all processes automatically from aspiration of thesample to outputting the results.Analysis results and graphics are displayed on the IPU screen. They |
| can be printed on any of the available printers or transmitted to a Hostcomputer. | |
| 5. Description ofModification: | The modification that was made is the addition of the Urinalysis WAMsoftware on the IPU of the UF-1000i. This software is a modular workarea management (WAM) system for data processing and acts as anindependent data manager system that interfaces with the UF-1000i andthe LIS (Laboratory Information System). This data manager has thecapability for patient demographics, test orders and test results. Itprovides a library of rules for reflex orders for repeats or additionaltesting. |
| 6. Intended Use: | The Sysmex® UF-1000i is an automated urine particle analyzer for invitro diagnostic use in screening patient populations found in clinicallaboratories. The UF-1000i analyzes the following parameters in urinesamples: RBC, WBC, Epithelial Cells, Cast, and Bacteria and flags thepresence of the following: Pathologic Cast, Crystal, Sperm, SmallRound Cell, Yeast like cell and Mucus. |
| 7. Substantialequivalence-Similarities andDifferences: | Design validation studies were completed and sample integrity studywas performed. and there is no difference between the UF-1000i andthe UF-1000i with Urinalysis WAM software. |
| 8. Conclusion | The UF-1000i with Urinalysis WAM software demonstrates substantialequivalence to the UF-1000i without the Urinalysis WAM software. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY - 2 2008
Sysmex America, Inc. C/O Nina Gamperling One Nelson C. White Parkway Mundelein, Illinois 60060
Re: K080887
Trade/Device Name: Sysmex® UF-1000i, Automated Urine Particle Analyzer with Urinalysis WAM Regulation Number: 21 CFR 864.5200 Regulation Name: Automated Urine Particle Analyzer Regulatory Class: Class II Product Code: LKM Dated: March 28, 2008 Received: April 1, 2008
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
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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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080887
Device Name: Sysmex® UF-100i,Automated Urine Particle Analyzer with Urinalysis WAM
Indications for Use:
Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UF-1000i 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 and Mucus.
Steerline Buntader
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K080887
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).