MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER

K052905 · Beckman Coulter, Inc. · GKZ · Nov 18, 2005 · Hematology

Device Facts

• Record ID: K052905
• Device Name: MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Nov 18, 2005
• 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 provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

Device Story

Device modification involves labeling update for quality control (QC) procedure regarding nucleated red blood cells (NRBCs). Modification tightens standard deviation (SD) range by limiting positive sample range to ≥2% and ≤15%. Device used in laboratory settings for hematology quality control. Healthcare providers use QC output to verify instrument performance and ensure accuracy of patient test results. Benefit includes improved precision and reliability of NRBC measurements.

Clinical Evidence

No clinical data provided. The submission is a special 510(k) for a labeling modification regarding QC procedures for NRBC determinations.

Technological Characteristics

In vitro diagnostic quality control material for hematology analysis. Modification involves tightening QC parameter limits for NRBCs. Device relies on established laboratory QC protocols.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for quantitative automated hematology analysis, leukocyte differential counting, reticulocyte analysis, NRBC enumeration, and RBC/WBC enumeration in body fluids.

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.”

Submission Summary (Full Text)

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K052905

# NOV 1 8 2005

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

#### 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 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:

October 13, 2005

### 2.0 Legally Marketed Device(s)

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

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, 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 COUL TER® hematology analyzers.

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- · COULTER CLENZ® cleaning agent to prevent protein buildup on surfaces.
- · COULTER Latron™ Primer and Latron Control (K885028) to monitor VCS performance.
- · COULTER LH 700 SERIES Pak, containing Erythrolyse™ bytic reagent and Stabilyse™ to
lydies and the more to the take to the differentiation into submonylations COULTER LH 700 SERIES Fak, containing Elyth Style Poplic Forestigations.
- 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 COULTER S-CAL® Hematology Oallbrator (10 100 -)); rate instrument measurements.

#### Principle of Method: 4.0

The COULTER LH 750 Hematology Analyzers utilizes the Coulter Principle for enumerating and The COULTEN LT 750 Ticmation's for sample processing and a single beam sizing blood cells, automatic and inking of the VCS (yolume, conductivity, light scater)
photometer for hemoglobinometry. They use COULTER VCS (yolume, was answaig, The spake photometer for nemogromomony. Internation and reticulocyte analysis. The analyzers lectified in TVDO Differential chargers and online and onlyth to lyse the red cells without use a reagent system consisting of an botenia and 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 For body holos analysis, spocillion is aspirated the in BBC baths. The Coulter Method of counting cells is used mode and is unded in Soparato WBO arrical resistance when a cell, suspended in a conductive to delect and measure changes in block. Surpended cell acts as an insulator. As the cell ulldent, passes through a omail momentarily increases the resistance of the electrical path passes through the upondio, in merced on each side of the aperture. The resistance between two submorged stock of electrical pulses are channelized, processed generates an electifical pulse. The aloualibration factor, yielding the WBC and RBC counts.

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

#### Indications for Use (Intended Use): 5.0

The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and THE COULTER LT POSTIGINAL Counter For In Clinical laboratories. The COULTER LH leukocyte unferential oomier for in Ville Diegne analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

#### 6.0 Description of the modification:

The labeling for the marketed COULTER LH 750 hematology analyzer will be modified relative to draft product labeling submitted in the original premarket notification (K011342) to reflect new instructions for performing QC for NRBC determinations.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

NOV 1 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k052905

> Trade/Device Name: COULTER® LH 750 Hematology Analyzer: Change to NRBC QC Method Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: October 13, 2005 Received: October 14, 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, 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/industry/support/index.html

Sincerely yours,

lobetz Beckerh

Robert L. Becker, Jr., MD, PH. 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

K052905

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

COULTER® LH 750 Hematology Analyzer Device:

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 provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

# 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)

Robert Becker J
Division Sign-Off

fice of In Vitro Diagnostic Device Evaluation and Safe

510(k) K052903

LH 750- NRBC QC Method Special 510k

Beckman Coulter, Inc.