COULTER LH 750 HEMATOLOGY ANALYZER

K032342 · Beckman Coulter, Inc. · GKZ · Sep 26, 2003 · Hematology

Device Facts

• Record ID: K032342
• Device Name: COULTER LH 750 HEMATOLOGY ANALYZER
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Sep 26, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Coulter LH 750 Hematology Analyzer with Version 2B Software is designed for in vitro diagnostic use in clinical laboratories. The LH 750 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis. The purpose of the LH 750 Hematology Analyzer with Version 2B Software is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size, and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.

Device Story

Automated hematology analyzer; processes whole blood samples via open or closed tube sampling; utilizes barcode identification; performs complete blood count, leukocyte differential, NRBC enumeration, and reticulocyte analysis; identifies normal vs. abnormal patient samples to flag need for manual review or further diagnostic testing; used in clinical laboratory settings by trained laboratory personnel; output provided to healthcare providers to assist in clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. Performance validation focused on improved NRBC enumeration and WBC correction fail-safes compared to the predicate device.

Technological Characteristics

Automated hematology analyzer; utilizes Coulter Principle (impedance) for cell counting/sizing, single beam photometry for hemoglobin, and VCS (volume, conductivity, light scatter) technology for WBC/reticulocyte analysis. Reagent-based system (diluent, lytic agents, cleaner). Software-controlled; supports cyanide-free reagents.

Indications for Use

Indicated for use in clinical laboratories for quantitative, automated hematology analysis, including complete blood count, leukocyte differential, NRBC enumeration, and reticulocyte analysis.

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 Hematology Analyzer with Version 2A Software (K011342)

Submission Summary (Full Text)

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K03234-2

### 510(k) Summary of Safety and Effectiveness for Section 1 D:

LH 750 Hematology Analyzer with Ver. 2B Software

#### 1.0 General Information

| Applicant Name and Address: | Beckman Coulter, Inc.<br>Cellular Analysis Division<br>11800 SW 147 Avenue<br>Miami, FL 33196-2500 |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Stan Sugrue, Ph.D.<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>FAX: [phone]<br>E-mail: [e-mail] |
| Date: | July 28, 2003 |
| Device Trade Name(s):<br>Device Generic Name(s): | LH 750 Hematology Analyzer<br>Automated differential cell counter |
| Device Classification: | The LH 750 Hematology Analyzer with Ver. 2B Software is<br>a Class II medical device. |

#### 2.0 Predicate Device

The LH 750 Hematology Analyzer with Ver. 2B Software claims substantial equivalence to the COULTER LH 750 hematology analyzer.

FDA 510(k) Number(s): K011342

#### 3.0 Device Description

LH 750 Hematology Analyzer with Ver. 2B Software is designed For In Vitro Diagnostic Use in clinical laboratories. The LH 750 provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis. The purpose of the LH 750 Hematology Analyzer with Ver. 2B Software is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, biochemical investigations, manual WBC differential or any other definitive test that helps diagnose the patient's condition.

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 and NRBC enumeration.

The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting and sizing, reticulocyte determination, quality control, calibration and cleaning.

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#### 4.0 Principle of Method:

The COULTER LH 750 Hematology Analyzer with Ver. 2B Software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer. Both devices utilize the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume, 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.

| Comparison | Characteristic | COULTER LH 750<br>(Predicate) | COULTER LH 750 w/ 2B SW |
|--------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Similarities | Intended Use | The COULTER® LH 750<br>Hematology Analyzer is a<br>quantitative, automated<br>hematology Analyzer and<br>leukocyte differential counter<br>For In Vitro Diagnostic Use in<br>clinical laboratories. | Same as LH 750 |
| | Analysis Reagents | COULTER® LH Series Diluent<br>COULTER LH SERIES Pak<br>COULTER Lyse S® III lytic<br>agent | Same as LH 750 |
| | Cleaning Agent | COULTER CLENZ | Same as LH 750 |
| | Hematology Quality<br>Controls | COULTER® 5C Cell Control<br>COULTER® Latron Primer and<br>Latron Control<br>RETIC-C Cell Control<br>Lin-C linearity control | Same as LH 750 |
| | Reticulocyte analysis<br>reagent system | LH SERIES RETIC Pak | Same as LH 750 |
| | Reticulocyte analysis<br>method | Automated | Same as LH 750 |
| Differences | Analysis Reagents | Not qualified for use with<br>COULTER cyanide-free<br>reagents | Qualified for use with<br>COULTER cyanide-free<br>reagents |
| | Labeling | Not IVDD compliant | Consistent with IVDD<br>regulation |
| | Parameter Performance | Has NRBC enumeration | Improved NRBC<br>performance for False<br>Negatives |
| | Parameter Performance | Has WBC correction | Added additional Fail safe |

#### 5.0 Comparison to Predicate

#### Indications for Use: 6.0

The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP 2 6 2003

Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Beckman Coulter, Inc. Cellular Analysis Division 11800 SW 147 Avenue Miami. Florida 33196-2500

Re: k032342

Trade/Device Name: Coulter® LH 750 Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: July 28, 2003 Received: July 29, 2003

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, or questions 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/dsma/dsmamain.html.

Sincerely yours,

steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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

K032342

### 510(k) Number (if known): 14

Device: COULTER® LH 750

> The COULTER® LH 750 is a quantitative, automated hematology analyzer For In Vitro Diagnostic Use in clinical laboratories. The LH 750 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis.

## 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

Over-The-Counter

Josephine Rautski

**Division Sign-off**

n Vitro Diagnostic Device

**510(k)** k032342

Beckman Coulter, Inc. LH 750 with Version 2B Software - Abbreviated 510(k)