COULTER LH 750 HEMATOLOGY ANALYZER

K050057 · Beckman Coulter, Inc. · GKZ · Feb 10, 2005 · Hematology

Device Facts

• Record ID: K050057
• Device Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Feb 10, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The LH 750 Series Body Fluid Application is a procedure for obtaining in vitro quantitative determinations of leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid, using a Coulter LH 700 Series Hematology Analyzer.

Device Story

Coulter LH 750 is a quantitative hematology analyzer; performs CBC, leukocyte differential, reticulocyte analysis, and nucleated RBC counts. For body fluid analysis, samples are manually aspirated and diluted in separate WBC and RBC baths. Device utilizes Coulter Principle (electrical impedance) to detect/measure resistance changes as cells pass through apertures; pulses are channelized, corrected for coincidence, and calibrated to yield WBC and RBC counts. System uses isotonic diluent, lytic reagents, and instrument cleaner. Operated in manual mode by laboratory personnel. Output provides quantitative cell counts for clinical diagnostic use. Modification in this submission updates sample stability claims for synovial and serous fluids.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, risk analysis, and Declaration of Conformity with Design Controls confirming product specifications were met.

Technological Characteristics

Uses Coulter Principle (electrical impedance) and Coulter VCS (volume, conductivity, light scatter) technology. Reagents include isotonic diluent, lytic reagents, and instrument cleaner. System performs automated dilution and mixing. Connectivity via barcode scanner or manual input. Software-controlled analysis.

Indications for Use

Indicated for in vitro quantitative determination of leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal, serous, and synovial fluids using the Coulter LH 700 Series Hematology Analyzer.

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• Coulter LH 750 Body Fluids Application (K030606)

Submission Summary (Full Text)

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FEB 1 0 2005

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### Summary of Safety and Effectiveness for Section 1 D: COULTER® LH 750 Hematology Analyzer

#### General Information 1.0

| Device Generic Name(s): | Automated differential cell counter |
|-----------------------------|----------------------------------------------------------------------------------------------------|
| Device Trade Name(s): | COULTER® LH 750 Hematology Analyzer |
| Device Classification: | The COULTER® LH 750 Hematology Analyzer is a Class II medical<br>device. |
| Applicant Name and Address: | Beckman Coulter, Inc.<br>Cellular Analysis Division<br>11800 SW 147 Avenue<br>Miami, FL 33196-2500 |

Date:

January 10, 2005

#### Legally Marketed Device(s) 2.0

The modified COULTER® LH 750 Hematology Analyzer claims substantial equivalence to the previously cleared COULTER® LH 750 Body Fluids Application.

FDA 510(k) Number(s): K030606

#### 3.0 Device Description

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis, enumeration of nucleated red blood cells (NRBCs) in whole blood and leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid. The following reagents, with 510(k) numbers indicated where applicable, are qualified for use on the COULTER LH 750 Hematology Analyzer with Version 2B (or higher) software:

- · 5C® Cell Control (K781969) and COULTER RETIC-C™ Cell control (K930119) hematology quality control materials used to monitor the instrument performance. COULTER® LIN-C® linearity control (K955334) verifies reportable range of the CBC parameters.
- · COULTER® LH 700 SERIES or ISOTON 4 Diluent. Intended for use as a diluent for counting and sizing blood cells on COULTER® LH 700 SERIES hematology analyzers.
- · COULTER Lyse S® III diff or Lyse S® 4. Intended for the simultaneous quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER® hematology analyzers.
- · COULTER CLENZ® cleaning agent to prevent protein buildup on surfaces.
- · COULTER Latron™ Primer and Latron Control (K885028) to monitor VCS performance.

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- · COULTER LH 700 SERIES Pak, containing Erythrolyse™ tytic reagent and Stabilyse™ to oooe fer Er. Er. roe State to allow differentiation into subpopulations.
- · COULTER LH 700 SERIES RETIC Pak, containing Reagent A and Reagent B, is used for clearing red cells and staining reticulocytes.
- COULTER S-CAL® Hematology Calibrator (K840794), alternative to whole blood reference method of calibration. Intended for use in ensuring accurate instrument measurements.

#### Principle of Method: 4.0

The COULTER LH 750 Hematology Analyzers utilizes the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam Sizing blood oche, actornatio and ... They use COULTER VCS (yolume, conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent, lytic reagents to lyse the red cells without significantly affecting the white cells and an instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.

For body fluids analysis, specimen is aspirated into the LH 700 Series Analyzer via the manual mode and is diluted in separate WBC and RBC baths. The Coulter Method of counting cells is used to detect and measure changes in electrical resistance when a cell, suspended in a conductive diluent, passes through a small aperture. Each suspended cell acts as an insulator. As the cell passes through the aperture, it momentarily increases the resistance of the electrical path between two submerged electrodes, one located on each side of the aperture. The resistance botwoon the cabrical pulse. The accumulation of electrical pulses are channelized, processed for coincidence correction, and multiplied by a calibration factor, yielding the WBC and RBC counts.

The WBC result represents the TNC (total nucleated cell count) in the analysis of Body Fluids.

#### 5.0 Indications for Use:

The COULTER® LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® LH 750 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) in whole blood and white blood cells (WBCs) and red blood cells (RBCs) in body fluids.

#### Description of the modification: 6.0

The labeling for the marketed COULTER LH 750 hematology analyzer with Version 2B software release will be modified relative to draft product labeling submitted in the original premarket notification (K030606) to indicate a sample stability of eight (8) hours for synovial fluid analysis (rather than 1 hour) and eight (8) hours for serous fluid analysis (rather than 24 hours) to reflect actual validated performance.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized wing shapes.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Premarket Product Regulatory Compliance Beckman Coulter, Inc. 11800 SW 147 Avenue Miami, Florida 33196-2500

FEB 1 0 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

k050057 Re:

Trade/Device Name: COULTER® LH 750 Hematology Analyzer Body Fluids Application Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: January 10, 2005 Received: January 11, 2005

Dear Dr. Sugrue:

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

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If you desire specific information about the application of labeling requirements to your device, n you stions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PK.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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Section 1C:

# INDICATIONS FOR USE

K05005 Not assigned 510(k) Number (if known):

COULTER® LH 750 Body Fluids Application Device:

Intended Use:

The LH 700 Series Body Fluid Application is a procedure for obtaining in vitro The EN 700 Geterminations of leukocytes (WBC) and erythrocytes (RBC) in quantitative determinations of Barbovial fluid, using a COULTER LH 700 Series Hematology Analyzer.

# 21 CFR 864.5220 Automated differential cell counter

An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

Prescription Use X

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division Sign-off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050057

LH 750- Synovial Fluid Sample Stability Special 510k

Beckman Coulter, Inc.