MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

K022161 · Beckman Coulter, Inc. · GKZ · Jul 29, 2002 · Hematology

Device Facts

• Record ID: K022161
• Device Name: MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended 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).

Device Story

Automated hematology analyzer for clinical laboratories; performs complete blood cell analysis, leukocyte differential counts, reticulocyte analysis, and NRBC enumeration. Uses Coulter Principle for cell counting/sizing; single beam photometer for hemoglobinometry; VCS (volume, conductivity, light scatter) technology for WBC differential and reticulocyte analysis. Requires specific reagents (diluents, lytic reagents, cleaners, stains) for sample processing. Operated by laboratory personnel. Output provides quantitative hematology data to assist clinicians in patient diagnosis and monitoring. Version 2A software update improves performance and reliability over Version 1A.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance improvements relative to the predicate device.

Technological Characteristics

Automated hematology analyzer; utilizes Coulter Principle (impedance) for cell counting/sizing, single beam photometer for hemoglobinometry, and VCS (volume, conductivity, light scatter) technology for WBC differential and reticulocyte analysis. Reagent-based system (diluents, lytic reagents, stains). Software-controlled processing.

Indications for Use

Indicated for use in clinical laboratories as a quantitative, automated hematology analyzer and leukocyte differential counter. Provides automated reticulocyte analysis and nucleated red blood cell (NRBC) enumeration for blood samples.

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 1A software (K011342)

Reference Devices

• 5C® -ES Cell Control (K010066)
• COULTER RETIC-C™ Cell control (K930119)
• COULTER® LIN-C® linearity control (K955334)
• COULTER Latron™ Primer and Latron Control (K885028)
• COULTER S-CAL® Hematology Calibrator (K840794)

Submission Summary (Full Text)

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JUL 29 2002

K022161

### Summary of Safety and Effectiveness for Section 1 D: COULTER® LH 750 Hematology Analyzer with Version 2A Software

### 1.0 General Information

| 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<br>medical device. |
| Applicant Name and Address: | Beckman Coulter, Inc.<br>Cellular Analysis Division<br>11800 SW 147 Avenue<br>Miami, FL 33196-2500 |
| Date: | July 2, 2002 |

### 2.0 Legally Marketed Device(s)

The modified COULTER® LH 750 Hematology Analyzer with Version 2A Software claims substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer with Version 1A software.

FDA 510(k) Number(s): K011342

### 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 and enumeration of nucleated red blood cells (NRBCs). The following reagents, with 510(k) numbers indicated where applicable, are qualified for use on the COULTER LH 750 Hematology Analyzer with Version 2A software:

- · 5C® -ES Cell Control (K010066) 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 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. 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.

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- · COULTER Latron™ Primer and Latron Control (K885028) to monitor VCS performance.
- · COULTER LH 700 SERIES Pak, containing Erythrolyse™ lytic reagent and Stabilyse™ to preserve leukocytes in near-native 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 Analyzer with Version 2A software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer with Version 1A software. 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.

#### 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 nucleated red blood cell (NRBC) enumeration.

### 6.0 Description of the modification:

The currently marketed COULTER LH 750 hematology analyzer with Version 1A software release was modified with software and minor hardware changes to improve performance characteristics and reliability.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized symbol that resembles three abstract human profiles or faces, stacked on top of each other. The symbol is rendered in black and has a flowing, wave-like quality.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUL 2 9 2002

Stan Sugrue, Ph.D. Senior Regulatory Affairs Specialist Premarket Product Regulatory Compliance Beckman Coulter Inc. 11800 SW 147 Avenue MC 31-B06 Miami, FL 33196-2500

k022161 Re:

> Trade/Device Name: COULTER® LH 750 Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: July 2, 2002 Received: July 3, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 1C:

## INDICATIONS FOR USE

510(k) Number (if known): Johassigned

COULTER® LH 750 Hematology Analyzer Device:

## 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).

Future commercialization will add ISOTON® 4 diluent /Lyse S® 4 Lytic reagent to the indications for use.

## 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.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use/

(Per 21 CFR 801.109)

Use

OR

Over-The-Counter

Josephine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices K022161
510(k) Number

LH 750 with Version 2A- Special 510k

Beckman Coulter, Inc.

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