CELL-DYN 1800 SYSTEM

K030513 · Abbott Laboratories · GKZ · May 12, 2003 · Hematology

Device Facts

• Record ID: K030513
• Device Name: CELL-DYN 1800 SYSTEM
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: May 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The CELL-DYN 1800 System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories.

Device Story

The CELL-DYN 1800 is a benchtop automated hematology analyzer for clinical laboratory use. It accepts open EDTA-anticoagulated blood samples via manual aspiration. The system utilizes electrical impedance (von Behrens Transducer) for cell counting and sizing, and LED-based hemoglobin analysis. It incorporates a microprocessor for system control, data acquisition, and analysis. The device outputs results to an integrated LCD monitor, printer, or LIS via RS232 interface. It provides dispersional data alerts, suspect parameter messages, and suspect population flags to assist clinicians in data review. The system features a cyanide-free differential lyse reagent and barcode scanning capability. By automating hematological analysis, the device assists healthcare providers in diagnostic assessment of blood cell parameters.

Clinical Evidence

In-house clinical trial comparing CELL-DYN 1800 to the predicate CELL-DYN 1700. Data included background, correlation, precision, linearity, sensitivity, specificity, and carryover. Results supported substantial equivalence.

Technological Characteristics

Benchtop analyzer; electrical impedance (von Behrens Transducer) for cell counting/sizing; LED hemoglobin analysis; volumetric metering (ICSH method); cyanide-free differential lyse reagent; RS232 LIS connectivity; LCD monitor; barcode scanner input; microprocessor-controlled.

Indications for Use

Indicated for use in clinical laboratories to report sixteen parameters relating to the cells of EDTA-anticoagulated blood.

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

• Abbott CELL-DYN 1700 System (K870233)

Submission Summary (Full Text)

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| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of<br>SMDA 1990 and 21 CFR 807.92. | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| | The assigned 510(k) number is: | K030513 |
| | CELL-DYN® 1800 System | |
| Submitted by | Abbott Laboratories<br>5440 Patrick Henry Drive<br>Santa Clara, CA 95054 | |
| Contact Person | John Dean<br>Phone [phone]<br>Fax | [phone] |
| Date Prepared | February 14, 2003 | |
| Proprietary Name | CELL-DYN® 1800 System | |
| Common Name | Automated Hematology Analyzer | |
| Classification Name | Automated Differential Cell Counter<br>(21 CFR 864.5220) | |
| Predicate Device | Abbott CELL-DYN 1700 System, K870233 | |
| Device<br>Description | The CELL-DYN 1800 System is a benchtop analyzer<br>consisting of the main analyzer with data module, display<br>station, and printer. The main analyzer, data module, and<br>display station are housed in a single chassis. The printer is a<br>stand-alone module. The CELL-DYN 1800 open sampler is<br>equipped to aspirate blood from a collection tube that has been<br>opened and is held under the open sample aspiration probe. | |
| Intended<br>Use | The CELL-DYN 1800 System has the same intended use as<br>previously cleared for the CELL-DYN 1700 System, K870233 | |
| | The CELL-DYN 1800 System is a multiparameter, automated<br>hematology analyzer designed for <i>in vitro</i> diagnostic use in<br>clinical laboratories. | |

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| Similarities | | |
|--------------|--|--|
| And | | |
| Differences | | |

The CELL-DYN 1800 System and the CELL-DYN 1700 System are similar in that:

- a) Both systems accept open specimens presented manually by the operator.
- Both systems automatically aspirate the specimen and present b) it for automated processing.
- c) Both systems use microprocessors for systems control, data acquisition, and data analysis.
- d) Both systems accept input from keyboard and send data output to: video screen, hard drive, and printer; and both systems provide RS232 Interface to an on-line LIS.
- e) Both systems provide Dispersional Data Alerts, Suspect Parameter Messages, and Suspect Population Flags to assist in data review.
- f) Both Systems use electrical impedance on the von Behrens Transducer for counting and sizing cells.
- Both systems use LED Hemoglobin analysis. g)
- Both systems use Volumetric Metering as the Reference ICSH h) Method.

The CELL-DYN 1800 System and the CELL-DYN 1700 System are different in that:

- The CELL-DYN 1800 System uses Cyanide-Free differential a) lyse reagent, while the CELL-DYN 1700 uses a cyanidecontaining lytic agent.
- b) The CELL-DYN 1800 System is capable of inputting specimen information from a bar code through a hand held bar code scanner, while the CELL-DYN 1700 System does not have bar code scanning capabilities.
- c) The CELL-DYN 1800 is capable of data output to both a dot matrix printer and an inkjet printer, while the CELL-DYN 1700 is only capable of data output to a dot matrix printer.
- d) The CELL-DYN 1800 is a smaller and more compact system than the CELL-DYN 1700 System.
- e) The CELL-DYN 1800 has a High Resolution Color Monitor (LCD), while the CELL-DYN 1700 has a High Resolution Color Monitor (CRT).
- f) The CELL-DYN 1800 has a Patient Data Storage of 10.000 Run Cycles, while the CELL-DYN 1700 has a Patient Data Storage of 5,000 Run Cycles.

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| Clinical Study<br>Protocol | The Clinical Study Protocol for the CELL-DYN 1800 is found<br>in Attachment E. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalency<br>Data Summary | The CELL-DYN 1800 System is a multi-parameter, automated<br>hematology analyzer for in vitro diagnostic use in clinical<br>laboratories. The CELL-DYN 1800 System, which includes<br>reagents and software, was compared in an in-house clinical<br>trial to the CELL-DYN 1700 System. The data compiled<br>supports the claim that the CELL-DYN 1800 System is<br>substantially equivalent to the CELL-DYN 1700 System and<br>includes data for background, correlation, precision, linearity,<br>sensitivity and specificity, and carryover. The data supporting<br>the claim that the CELL-DYN 1800 is substantially equivalent<br>to the CELL-DYN 1700 is found in Attachment F. |
| Conclusion | The CELL-DYN 1800 System is substantially equivalent to the<br>CELL-DYN 1700 (predicate device). The differences noted do<br>not pose new questions of safety and effectiveness. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John Dean Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054

MAY 12 2003

Re: k030513 Trade/Device Name: CELL-DYN® 1800 System Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: February 14, 2003 Received: February 19, 2003

Dear Mr. Dean:

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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## Indications for Use Statement

510(k) Number (if known): K 03 0513

Device Name:

CELL-DYN® 1800 System

Indications for Use:

The CELL-DYN 1800 System is an automated, multiparameter hematology analyzer designed to report sixteen parameters relating to the cells of EDTA-anticoagulated blood.

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| | | 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) |

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K030513 |
|---------------|---------|
|---------------|---------|