ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS

K980614 · Abbott Laboratories · GKZ · Apr 24, 1998 · Hematology

Device Facts

• Record ID: K980614
• Device Name: ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The Cell-Dyn® 3000 Series instruments are automated hematology analyzers intended for in-vitro diagnostic use in the clinical laboratory and the Physician's Office Laboratory (POL).

Device Story

CELL-DYN 3000 Series are automated multi-parameter hematology analyzers; used in clinical laboratories and physician office laboratories (POLs). Input: K3EDTA anticoagulated human whole blood. Operation: analyzer module aspirates/dilutes specimens; uses Helium-Neon laser optical scatter (0°, 10°, 90°, 90°D angles) and/or impedance to count, size, and classify blood cells. Hemoglobin measured via optical absorbance at 540nm. Data station controls processing and operator interface; printer generates reports. Output: comprehensive hematological parameters (WBC, RBC, HGB, PLT, and differential counts). Healthcare providers use output for diagnostic hematology assessment. Benefits: automated, rapid blood cell analysis and differential reporting.

Clinical Evidence

Bench testing only. Equivalence demonstrated via accuracy, precision, linearity, and carryover studies comparing the CELL-DYN 3200 to the CELL-DYN 3500R. Parameters evaluated include WBC, WBC differential subpopulations, RBC, HGB, MCV, RDW, PLT, and MPV. Results confirmed performance met manufacturer specifications.

Technological Characteristics

Automated hematology analyzer; Helium-Neon laser optical light source; optical scatter (0°, 10°, 90°, 90°D) and impedance sensing principles; optical absorbance at 540nm for hemoglobin; processes K3EDTA anticoagulated human whole blood; modular design (analyzer, data station, printer).

Indications for Use

Indicated for processing human whole blood specimens to provide a hemogram with automated differential in clinical laboratory and physician office settings.

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

• CELL-DYN® 3200 (K972354)
• CELL-DYN® 3500R (K960427)
• CELL-DYN® 3000 (K955673)

Submission Summary (Full Text)

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AFR 2 4 1998

CELL-DYN 3000 Series Hematology Systems

K980614

510(k) Supplement

# 510(k) SUMMARY CELL-DYN® 3000 Series Hematology Systems POL Supplement

# 510(k) Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the 510(k) Supplement to Expand the Intended Use for Physician's Office Laboratories (POLs) for the Abbott CELL-DYN®3200 (K972354), the CELL-DYN® 3500R (K960427) and the CELL-DYN® 3000 (K955673) Systems constitutes data supporting a substantially equivalent determination. These three systems are referred to as the CELL-DYN® 3000 Series. The methods of determination while operated in POLs are those used by the CELL-DYN® 3000 Series.

#### Intended Use

The CELL-DYN® 3000 Series are automated, multi-parameter hematology analyzers intended for in-vitro diagnostic use in the Clinical Laboratory and the Physician's Office Laboratory (POL).

#### Device Description

The CELL-DYN® 3000 Series instruments each consist of three major modules: the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen; the Data Station/Module, which controls all system processing and provides the primary operator interface with the system; and the Printer, which generates reports automatically or on demand.

The CELL-DYN® 3000 Series instruments are designed to analyze K3EDTA anticoagulated human whole blood specimens and report the hematological parameters shown in the table on the following page:

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### Reported Parameters

| White Blood Cell Parameters: | Red Blood Cell Parameters: |
|--------------------------------------------|------------------------------------------------------|
| WBC -- White Blood Cell or leukocyte Count | RBC -- Red Blood Cell or erythrocyte count |
| NEU -- Neutrophil absolute count | HCT -- Hematocrit |
| %N -- Neutrophil percent | MCV -- Mean Corpuscular Volume |
| LYM -- Lymphocyte absolute count | RDW -- Red Cell Distribution Width |
| %L -- Lymphocyte percent | RETC -- Reticulocytes (CELL-DYN 3500R only) |
| MONO -- Monocyte absolute count | MCH -- Mean Corpuscular Hemoglobin |
| %M -- Monocyte percent | MCHC -- Mean Corpuscular Hemoglobin<br>Concentration |
| EOS -- Eosinophil absolute count | |
| %E -- Eosinophil percent | Platelet Parameters: |
| BASO -- Basophil absolute count | PLT -- Platelet Count |
| %B -- Basophil percent | MPV -- Mean Platelet Volume |
| Hemoglobin Parameters: | *PDW -- Platelet Distribution Width |
| HGB -- Hemoglobin concentration | *PCT -- Plateletcrit |

* These parameters are provided for laboratory use only and are not reportable in the US.

#### Principles of Operation:

The Cell-Dyn® 3000 series count, size and classify blood cells by a combination of methods: flow cytometry laser optical scatter and/or impedance. The instruments use a Helium-Neon laser as the optical light source. The Optical Bench detects light in the form of scatter from blood cell surfaces and internal structures.

For the WBC parameters, whole blood is diluted with a reagent to preserve cell integrity. Data are simultaneously collected for four angles (0°, 10°, 90°, and 90°D) of light scatter as . each cell passes through the laser beam. For the RBC and PLT parameters, whole blood is diluted with a reagent that prepares the cells for measurement. The dilution is split and measured by laser optical scatter at (0° and 10°) or impedance.

For the hemoglobin parameter, whole blood is diluted with a cyanide free and/or cyanide containing reagent and the hemoglobin is measured optically by absorbance at 540nm.

#### Similarities and Differences:

The CELL-DYN® 3000 Series instruments are all similar in that they utilize Optical Laser Light Scatter from a Helium neon Laser to count and differentiate WBCs, they use anticoagulated human whole blood specimens, they automatically dilute and aspirate specimens, and specimens may be run using automated specimen processing. All count fragile WBCs, all have extended counts for WBCs and PLTs, all measure Hemoglobin by Optical Absorbance and all have internal Quality Control programs.

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The CELL-DYN® 3000 Series are different in that the CELL-DYN® 3500R and the CELL-DYN® 3000 utilize impedance for counting and sizing RBCs and PLTs, while the CELL-DYN® 3200 utilizes Optical Light Scatter. Only the CELL-DYN® 3500R has the capability of counting and reporting Reticulocyte results.

## Equivalency Data:

The data compiled to support the claim that the CELL-DYN® 3200 System is substantially equivalent when used in a POL to the other CELL-DYN® 3000 series instruments includes background, accuracy, precision, linearity, and carryover. Equivalence is demonstrated between the CELL-DYN® 3200 System and the CELL-DYN® 3500R System for the following measured parameters: White Blood Count (WBC), WBC differential sub populations. Red Blood Count (RBC). Hemoglobin concentration (HGB), Mean Corpuscular Volume (MCV), Red Cell Distribution Width (RDW), Platelet Count (PLT) and Mean Platelet Volume (MPV). Accuracy, precision, and linearity data show performance to manufacturer's specifications.

### Conclusion:

There are more similarities between the CELL-DYN® 3000 Series of instruments than there are differences. Demonstration of the equivalence of the CELL-DYN® 3200 data to the CELL-DYN® 3500R and the similarities of the CELL-DYN® 3000 Series, provides the validation for an extension of the Intended Use to include Physician's Office Laboratories (POLs).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

2098 Gaither Road Rockville MD 20850

Food and Drug Administration

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a curved, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.

## APR 2 4 1998

Ms. Janice E. Brown Requlatory Affairs Manager Abbott Laboratories Diaqnostics Division 5440 Patrick Henry Drive Santa Clara, California 95054

Re : K980614

Trade Name: Abbott Laboratories CELL-DYN® 3000 Series Hematology Systems Regulatory Class: II Product Code: GKZ Dated: January 30, 1998 Received: February 2, 1998

Dear Ms. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth. in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/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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# 510(k) Number (if known): CELL-DYN® 3200 System (K972354) CELL-DYN® 3500R (K960427) CELL-DYN® 3000 (K955673).

Device Name:

## CELL-DYN® 3000 Series of Instruments

Intended Use:

The Cell-Dyn® 3000 Series instruments are automated hematology analyzers intended for in-vitro diagnostic use in the clinical laboratory and the Physician's Office Laboratory (POL).

## Indications For Use:

The Cell-Dyn® 3000 Series instruments process human whole blood specimens to provide a hemogram with automated differential.

Ree E. Matin

Prescription doc