COULTER ACT 5DIFF AUTOLOADER (AL)

K030291 · Beckman Coulter, Inc. · GKZ · Apr 17, 2003 · Hematology

Device Facts

• Record ID: K030291
• Device Name: COULTER ACT 5DIFF AUTOLOADER (AL)
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Apr 17, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The COULTER® AcT™ 5diff Autoloader (AL) hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories.

Device Story

Moderate cost 5-part differential hematology analyzer; utilizes autoloader and external computer workstation. Inputs: whole blood samples (30µL for CBC, 53µL for CBC/DIFF). Principle of operation: aperture impedance for WBC, RBC, and platelet counting; spectrophotometry for hemoglobin measurement. Transforms electrical impedance and light scattering signals into quantitative hematology parameters. Output: 26 parameters including WBC, RBC, Hgb, Hct, MCV, MCH, MCHC, RDW, Plt, MPV, PDW, Pct, and 5-part leukocyte differential (Lymphocyte, Monocyte, Neutrophil, Eosinophil, Basophil counts/percentages). Used in clinical laboratories by trained personnel. Output assists clinicians in separating normal patients from those requiring further diagnostic investigation, such as manual differential or biochemical testing. Benefits include automated high-throughput screening (80 samples/hour) and improved diagnostic efficiency.

Clinical Evidence

Bench testing only. Performance data provided in the premarket notification supports substantial equivalence to legally marketed predicate devices. No clinical trial data reported.

Technological Characteristics

Automated hematology analyzer; aperture impedance sensing for WBC, RBC, Plt; spectrophotometric sensing for Hgb; light scattering for differential. Dimensions/form factor: includes autoloader and external workstation. Throughput: 80 samples/hour. Connectivity: external computer workstation. Software: automated analysis of impedance/scatter signals.

Indications for Use

Indicated for use in clinical laboratories as a quantitative, automated hematology analyzer and 5-part leukocyte differential counter for blood samples. Used to identify formed blood elements and flag, count, or classify immature or abnormal hematopoietic cells. Prescription use only.

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® HmX with Autoloader (K922704/A1)
• CELL-DYN® 4000 (K961439)

Submission Summary (Full Text)

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K03029/

Summary of Safety & Effectiveness COULTER® AcT™ 5diff Autoloader (AL)

# 1.0 Submitted By:

APR 1 7 2003

Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: [phone] FAX: [phone]

# 2.0 Date Submitted:

January 27, 2003

# 3.0 Device Name(s):

#### 3.1 Proprietary Names

COULTER® AcT™ 5diff Autoloader (AL)

# 3.2 Classification Name

Automated Differential Cell Counter (21 CFR § 864.5220)

# 4.0 Predicate Device:

| Candidate(s) | Predicate #1 | Manufacturer | Docket Number |
|------------------------------------------|---------------------------------|-----------------------|---------------|
| COULTER® AcT TM 5diff<br>Autoloader (AL) | COULTER® HmX with<br>Autoloader | Beckman Coulter, Inc. | K922704/A1 |
| | CELL-DYN® 4000* | Abbott Diagnostics** | K961439 |

* Trademark of Abbott Diagnostics

** Abbott Diagnostics, 5440 Patrick Henry Drive, Santa Clara, CA.

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# 5.0 Description:

The COULTER® AcT™ 5diff Autoloader (AL) is a moderate cost 5-part differential hematology analyzer with autoloader and external computer workstation.

# 6.0 Intended Use:

The COULTER® AcT™ 5diff Autoloader (AL) hematology analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories.

# Clinical Significance:

The purpose of the AcT 5diff AL 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 or distribution, biochemical investigations, manual WBC differential or any other derivative test that helps diagnosis of the patient's condition.

# 7.0 Comparison to Predicate(s):

COULTER® AcT™ 5diff Autoloader (AL) is substantially equivalent to theBeckman Coulter HmX with Autoloader and the Abbott CELL-DYN 4000.

| | Predicate Device (1) | Predicate Device (2) | Device |
|------------|----------------------------------------|---------------------------|----------------------------------|
| | Beckman Coulter<br>HmX with Autoloader | Abbott<br>CELL-DYN CD4000 | Beckman Coulter<br>A°•T 5diff AL |
| | | | |
| Parameters | 24 | 28 | 26 |
| | WBC, RBC, Hgb, Hct, | WBC, RBC, Hgb, Hct, | WBC, RBC, Hgb, Hct, |
| | MCV, MCH, MCHC, | MCV, MCH, MCHC, | MCV, MCH, MCHC, |
| | RDW, Plt, MPV, PDW*, | RDW, Plt, MPV, PDW*, | RDW, Plt, MPV, PDW*, |
| | Pct*, | Pct*, WBC Viable | Pct*, |
| | Lymphocyte % & #, | Fraction*, NRBC #, | Lymphocyte % & #, |
| | Monocyte % & # | NRBC / 100 WBC | Monocyte % & # |
| | Neutrophil % & # | Lymphocyte % & #, | Neutrophil % & # |
| | Eosinophil % & # | Monocyte % & # | Eosinophil % & # |
| | Basophil % & # | Neutrophil % & # | Basophil % & # |
| | | Eosinophil % & # | Atypical Lymph % & # * |
| | | Basophil % & # | Immature cell % & # * |
| | Reticulocyte % & # | Reticulocyte % & #<br>IRF | N/A |
| | * These parameters are | * These parameters are | • These parameters are |
| | for Research Use Only | for Research Use Only | for Research Use Only |
| | (RUO). Not for use in | (RUO). Not for use in | (RUO). Not for use in |
| | diagnostic procedures | diagnostic procedures | diagnostic procedures |

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| Principles of<br>Measurement | | | |
|---------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| WBC | Aperture impedance | Aperture Impedance /<br>Laser Light Scatter- | Aperture impedance |
| RBC | Aperture impedance | Aperture Impedance /<br>Laser Light Scatter | Aperture impedance |
| Hgb | Spectrophotometric | Spectrophotometric | Spectrophotometric |
| MCV | Aperture impedance | Aperture Impedance /<br>Laser Light Scatter | Calculated from Hct |
| Hct | Calculated from MCV | Calculated from MCV | Aperture impedance |
| Plt | Aperture impedance | Aperture Impedance /<br>Laser Light Scatter | Aperture impedance |
| Differential | Aperture impedance<br>Conductivity, Laser Light<br>Scatter (VCS) | Multi- angle Polarized<br>Scatter Separation<br>(MPASS) | Aperture Impedance<br>Light Scattering |
| Retics | Laser Light Scatter | Laser Light Scatter | N/A |
| NRBC and<br>Non viable<br>cells | N/A | Laser Light Scatter | N/A |
| Sample<br>Volume | Closed Vial Mode - 185µL<br>Open Vial Mode- 125µL | Manual or Automatic<br>Modes - 115µL | Open and Closed vial<br>modes<br>CBC profile - 30 µL<br>CBC/DIFF profile - 53µL |
| Throughput | Closed and Open Vial<br>mode - 75 samples/hour<br>Retics - 30 samples/hour | Closed tube mode -<br>115 samples/hour<br>Open Tube mode -<br>72 samples/hour | Closed and Open vial<br>mode -<br>80 samples/hour |

# 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence studies of the COULTER® AcT 5diff AL Hematology Analyzer to products already in commercial distribution.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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# Administrative Information COULTER® AcT™ 5diff Autoloader (AL)

### 1.0 SUBMITTED BY:

Beckman Coulter, Inc. 11800 SW 147th Avenue MC: 31-B06 Miami, FL 33196-2500 Establishment Registration No. 1061932

Primary Contact: Lourdes Coba, Senior Regulatory Affairs Specialist Telephone: [phone] FAX: [phone]

# Secondary Contact: Deborah Herrera, Group Manager, Regulatory Affairs Telephone: [phone] FAX: [phone]

# 2.0 PRODUCT NAME:

- A. PROPRIETARY NAME: COULTER® AcT™ 5diff Autoloader (AL)
- B. CLASSIFICATION NAME: Automated Differential Cell Counter (21 CFR § 864.5220)

# 3.0 CLASSIFICATION:

FDA classifies this instrument as a Class II device.

# 4.0 COMPLIANCE WITH & 514:

Neither performance standards nor other special controls have been promulgated for this test system.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 7 2003

Ms. Lourdes Coba Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 S.W. 147 Avenue M/S 31-Bo6 Miami, FL 33196-2500

Re: k030291

Trade/Device Name: COULTER® AcT™ 5diff Autoloader (AL) Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: January 27, 2003 Received: January 28, 2003

Dear Ms. Coba:

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).

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# Page 2 -

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.

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). 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 Putman

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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# 510(k) Number (if known): K 030291

COULTER® AcT™ 5diff Autoloader (AL) Hematology Analyzer Device Name:

Indications for Use:

The COULTER® AcT™ 5diff Autoloader (AL) hematology analyzer is a 26parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).

864.5240 Automated Differential Cell Counter

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 cvtometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96

*Spin Bauti*

(Division Sign-Off)
Division of Clinical Laboratory Devices K030291
510(k) Number

Beckman Coulter. Inc., Abbreviated 510(k) Notification AcT 5diff AL Section1.doc