SYSMEX UF-100

K961054 · Sysmex Corp. · LKM · Oct 28, 1996 · Hematology

Device Facts

• Record ID: K961054
• Device Name: SYSMEX UF-100
• Applicant: Sysmex Corp.
• Product Code: LKM · Hematology
• Decision Date: Oct 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

UF-Check™ is intended for use in the quality control of Sysmex UF-100™ automated urine analyzer. The Sysmex UF-100 is a in vitro medical device for use in urinalysis in clinical laboratories to replace microscopic review of normal and abnormal specimens and to flag specimens containing certain abnormalities.

Device Story

UF-Check is an assayed urinalysis control; suspension of particles representing red blood cells, white blood cells, epithelial cells, casts, and bacteria in liquid medium. Used in clinical laboratories to monitor performance of Sysmex UF-100 automated urine analyzer. Operates as five-part differential control; verifies system performance including dye addition, particle sizing, and element enumeration. Provides measurable values for QC mode parameters; ensures reproducibility and stability of analyzer results. Benefits patient by ensuring accuracy of urinalysis and flagging of abnormal specimens.

Clinical Evidence

Bench testing only. Studies included within-run precision, within-lot precision, and long-term stability. Results demonstrated consistent, reproducible performance for the duration of product dating. System performance verified via QC mode parameter measurement.

Technological Characteristics

Liquid suspension of particles (RBCs, WBCs, epithelial cells, casts, bacteria) in glass bottles (47 ml). Utilizes flow cytometry technology for particle detection and enumeration. Designed for use with Sysmex UF-100 automated analyzer.

Indications for Use

Indicated for use in clinical laboratories as an assayed quality control material for the Sysmex UF-100 automated urine analyzer to monitor performance of urinalysis testing.

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

• Ret-Check (K900484)
• SF-Check (K952245)

Submission Summary (Full Text)

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K961054
Oct. 28, 1996

Sysmex™

510(k) Summary of Safety and Effectiveness
Sysmex UF-Check™

510(k) Submitter:
Sysmex Corporation
Gilmer Road 6699 RFD
Long Grove, IL 60047-9596

Official Correspondent:
Nina Gamperling, MBA, MT(ASCP)
Supervisor, Clinical and Regulatory Affairs
Phone: [phone]; Fax: [phone]

Date Prepared:
June 24, 1996

Names of Device:
Trade Name: UF-Check
Common Name: Assayed Urinalysis Control
Classification Name: Urinalysis quality control mixture

Predicate Device:
Ret-Check (K900484)
SF-Check (K952245)

Description:
UF-Check is a suspension of particles representing red blood cells, white blood cells, epithelial cells, casts, and bacteria in a liquid medium. Sysmex UF-Check is supplied in glass bottles containing 47 ml volumes. Three bottles - one of each level- are packaged in one box.

Intended Use:
UF-Check™ is intended for use in the quality control of Sysmex UF-100™ automated urine analyzer. The Sysmex UF-100 is a in vitro medical device for use in urinalysis in clinical laboratories to replace microscopic review of normal and abnormal specimens and to flag specimens containing certain abnormalities.

Comparison with Predicate Device:
Like Ret-Check, UF-Check is intended as an assayed control for an automated analyzer which uses the same flow cytometry technology. Like SF-Check, UF-Check is intended as an assayed control for an automated analyzer to perform like a five-part differential control. These controls are manufactured to contain measureable elements in a liquid medium. The UF-Check is different from the predicate products in the chemical composition of elements to simulate an urine sample rather than a blood sample.

Discussion of Tests and Test Results:
Within Run Precision, Within Lot Precision, and Long Term Stability Studies were performed. Results were consistent and gave acceptable performance. UF-Check performs like a five-part differential control which when run in the QC mode gives values for the measurement of parameters. When run in the QC mode, all systems are checked for performance such as correct addition of dye, correct particle sizing, and correct enumeration of elements.

Conclusions Drawn from Tests:
Study results show UF-Check to be consistently reproducible and stable for the entire product dating. UF-Check is a safe and effective urinalysis control when used as instructed in the product package insert.

Sysmex Corporation
510(k) for UF-Check