SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE

K080887 · Sysmex America, Inc. · LKM · May 2, 2008 · Hematology

Device Facts

• Record ID: K080887
• Device Name: SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
• Applicant: Sysmex America, Inc.
• Product Code: LKM · Hematology
• Decision Date: May 2, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Indications for Use

The 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.

Device Story

Device modification involves addition of Urinalysis WAM (work area management) software system to existing urinalysis device. WAM software enables data processing and LIS (Laboratory Information System) interface. Device operates in laboratory setting; managed by laboratory personnel. Software facilitates automated data management and connectivity between urinalysis instrumentation and laboratory information systems. Modification does not alter fundamental scientific technology of parent device.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm modification impact and adherence to predetermined acceptance criteria.

Technological Characteristics

Urinalysis WAM software system; provides data processing and LIS interface capabilities. Software-based modification to existing urinalysis instrumentation.

Indications for Use

Indicated for in vitro diagnostic screening of urine samples in clinical laboratory settings to analyze RBC, WBC, Epithelial Cells, Cast, and Bacteria, and to flag Pathologic Cast, Crystal, Sperm, Small Round Cell, Yeast-like cell, and Mucus.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K080887

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The change was for the addition of the Urinalysis WAM (work area management) software system for data processing and LIS (Laboratory Information System) interface.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the addition of the Urinalysis WAM software on the IPU.

4. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

5. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Comments
(Reviewer's Signature)
(Date)

Revised: 3/27/98