K Number

Device Name

SYSMEX MODEL UF1000I

Manufacturer

SYSMEX AMERICA, INC.

Date Cleared

2007-05-25

(53 days)

Product Code

LKM GIF GJH JIW JJW

Regulation Number

864.5200

Intended 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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K961054

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "adaptive cluster analysis" but does not explicitly state or imply the use of AI or ML technologies. The focus is on flow cytometry and automated processes based on predefined parameters.

Therapeutic

No
The device is described as an automated urine particle analyzer for "in vitro diagnostic use in screening patient populations," which indicates it is used for diagnosis, not treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use." It analyzes various parameters in urine samples to screen patient populations, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including a Main Unit, Auto Sampler Unit, and IPU, which are integral to the device's function of analyzing urine samples. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Sysmex® UF-1000i is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."
Analysis of Biological Samples: The device analyzes urine samples, which are biological specimens.
Diagnostic Purpose: The analysis of urine particles (RBC, WBC, Epithelial Cells, Cast, Bacteria, etc.) is performed to aid in the diagnosis or screening of medical conditions.
Use in Clinical Laboratories: The intended user and setting are clinical laboratories, which are environments where IVD testing is performed.

All these factors align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

LKM, GIF, GJH, JIW, JJW

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Flow cytometry

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparison to the UF-100 demonstrated excellent correlation. Data consisting of carryover, linearity, accuracy and reproducibility show performance to the manufacturer's specifications. This analysis supports the claim that the UF-1000i is substantially equivalent to the UF-100.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K961054

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

5. 510(k) SUMMARY of the UF-1000i

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:

| 1. Submitted by: | Sysmex America, Inc.
One Nelson C. White Parkway
Mundelein, IL 60060
Phone: (847) 996-4675; FAX: (847) 996-4655
Contact person: Nina Gamperling
Date prepared: March 30, 2007 |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Name of Device: | Trade or proprietary name: Sysmex® UF-1000i
Common 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 printer
Bar code Reader
Rack Sampler Unit (UASU-3/UASU-4)
PU-17 |
| 3. Predicate Method: | Sysmex® UF-100 (K961054-Cleared October 28, 1996) |
| 4. Device Description: | 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. |
| 5. Intended 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. |
| 6. Substantial
equivalence-
Similarities and
Differences: | Table 1 shows substantial equivalence of the UF-1000i to the UF-100. |
| 7. Conclusion | The UF-1000i demonstrates substantial equivalence to the predicate
device. |

: .

Table 1: Substantial Equivalence—Similarities and Difference to UF-100
	Sysmex UF-100
Predicate	Sysmex UF-1000i
Modification of Predicate	Similarity/
Difference
Intended Use	The Sysmex™ UF-100 is
intended for in vitro
diagnostic use in clinical
laboratories. The UF-100
analyzes the following
parameters: RBC, WBC,
Epithelial Cells, Cast, and
Bacteria and flags the
presence of the following:
Pathologic Cast, Crystal,
Yeast like cell, Sperm and
Small Round Cell.	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.	The intended use
statement is the same.
The UF-1000i
analyzes the same
basic parameters but
has the addition of a
mucus flag.
Methodology	The instrument utilizes
Sysmex flow cytometry
using an argon laser for
analyzing organized
elements of urine. In
combination with flow
cytometry the UF-100 uses
an impedance
measurement.
The UF-100 uses flow
cytometry with impedance
measurement using a
double stain with two
fluorescent dyes. Particle
characterization and
identification is based on
detection of forward scatter,
fluorescence and
impedance signals and on
adaptive cluster analysis.	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.
The UF-1000i uses the same
methodology as the UF-100
with the addition of a new
bacteria channel and side
scattered light signal.	Both systems use the
same methodology
but the UF-1000i has
an additional bacteria
channel and side
scattered light signal.
Reagents	URINOSHEATH
URINOSEARCH
URINOPACK	UFII SHEATH
UFII SEARCH -SED
UFII PACK -SED
UFII SEARCH -BAC
UFII PACK -BAC	The UF-100 reagents
have been modified
for use on the UF-
1000i with the
addition of UF II
SEARCH -BAC and
UF II PACK-BAC for
the bacteria channel.
Quality
Control/
Calibrator	UF-CHECK—3 levels
UF-CAL	UFII CONTROL—2 levels
UFII CALIBRATOR	UF-1000i control
material has a similar
formulation for two

Table 1: Substantial Equivalence-Similarities and Difference to UF-100

| | | | control levels instead
of three. Calibrator
material is similar. |
|--------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software/
Hardware
Differences | One channel for sediment
only. | Two channels for bacteria and
sediment. | The UF-1000i has a
separate channel for
the detection of
bacteria. |
| Specimen
Type | Random urine sample | Random urine sample | Both systems use the
same specimen type. |
| Throughput | Approx. 100 samples/hour | Same as UF-100 | Both systems have the
same throughput. |
| Equivalency
Data: | Performance was
established in the UF-100
510(k) submission
(K961054). | Comparison to the UF-100
demonstrated excellent
correlation. | Data consisting of
carryover, linearity,
accuracy and
reproducibility show
performance to the
manufacturer's
specifications. This
analysis supports the
claim that the UF-
1000i is substantially
equivalent to the UF-
100. |

Image /page/4/Picture/1 description: The image shows a circular seal with a stylized eagle in the center. The eagle is depicted with three curved lines forming its body and wings. The seal is surrounded by text, which is difficult to read due to the image quality. The overall design appears to be a government or organizational emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 5 2007

Nina M. Gamperling Sysmex America, Inc. One Nelson C. White Parkway Mundelein, Illinois 60060

Re: K070910

Trade/Device Name: Sysmex ® UF-1000i Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: LKM Dated: March 30, 2007 Received: April 2, 2007

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 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

Page 2 - Nina M. Gamperling

predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). 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/dsma/dsmamain.html.

Sincerely yours,

Robe Rete

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	K070910
---------------------------	---------

Device Name: Sysmex® UF-1000i, Automated Urine Particle Analyzer

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 servering 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.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CHRD, Office of Device Evaluation (ODE)

Prescription Use	✓
------------------	---

Over-The-Counter Use
----------------------	--

Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k)	K070910
--------	---------

Sysmex UF-1000i, Automated Urine Particle Analyzer 510(k) FDA Submission