CELL-DYN RUBY SYSTEM

K061667 · Abbott Laboratories · GKZ · Jul 10, 2006 · Hematology

Device Facts

• Record ID: K061667
• Device Name: CELL-DYN RUBY SYSTEM
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

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

Device Story

Tabletop automated hematology analyzer; processes EDTA-anticoagulated human whole blood samples. Uses MAPSST technology (laser flow cytometry) and optical absorbance (Helium Neon laser) to measure WBC, RBC, PLT, and HGB parameters. Features automated sample loader for up to 50 closed tubes; manual loading also supported. System includes analyzer, data module, touch-sensitive LCD, and barcode reader. Software provides wizards for complex processes, system logs, and remote monitoring via AbbottLink. Output displayed on screen, printed, or sent to LIS via RS232. Assists clinicians in hematological assessment by providing automated cell counts and differential parameters; aids in rapid patient specimen identification and data review through suspect flags and dispersional data alerts.

Clinical Evidence

Bench testing only; design control activities and verification/validation testing performed to confirm that modifications met predetermined acceptance criteria.

Technological Characteristics

Tabletop analyzer; laser flow cytometry (MAPSST) and optical absorbance (HeNe laser). Reagent heaters for WBC/HGB. Connectivity: USB, RS232 (LIS), CD/DVD drive. Software: Windows XP-based with GUI, touch-screen, barcode reader, and remote monitoring (AbbottLink). Automated sample loader (50-tube capacity).

Indications for Use

Indicated for the analysis of EDTA-anticoagulated human whole blood to provide quantitative hematological parameters including WBC, RBC, HGB, PLT, and their associated differential and distribution indices in clinical and physician office laboratory 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 System

Submission Summary (Full Text)

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JUL 10 2006
K061667

______________________________________________________________________________________________________________________________________________________________________________

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of Safe<br>Medical Devices Act 1990 and 21 CFR 807.92. | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | CELL-DYN Ruby™ System | |
| Submitted by: | Abbott Laboratories<br>5440 Patrick Henry Drive<br>Santa Clara, CA 95054 | |
| Contact Person: | Michelle Roeding<br>Phone: [phone]<br>Fax: [phone] | |
| Date Prepared: | June 13, 2006 | |
| Proprietary Name | CELL-DYN Ruby™ System | |
| Common Name: | Automated Hematology Analyzer | |
| Classification Name: | Automated Differential Cell Counter<br>(21 CRF 864.5220) | |
| Predicate Device: | CELL-DYN® 3200 System | |
| | K972354 – September 16, 1997<br>K980614 – April 24, 1998<br>K012934 – September 28, 2001 | |
| Intended Use: | The CELL-DYN Ruby System is a multiparameter, automated<br>hematology analyzer designed for in vitro diagnostic use in<br>clinical laboratories and physician office laboratories. | |
| Device Description: | The CELL-DYN Ruby System is a tabletop analyzer consisting<br>of the main analyzer, data module, flat panel display station, and<br>printer. The main analyzer and data module are housed in a<br>single chassis. The display station and printer are stand-alone<br>modules. The CELL-DYN Ruby is equipped with a Sample<br>Loader that provides continuous automated closed sampling for<br>up to 50 closed tube samples at a time.<br>The instrument's utilizes the CELL-DYN MAPSST™ technology,<br>laser flow cytometry and a Microsoft® Windows® Operating<br>System, USB connectivity on the data module to allow the<br>interface of a wide variety of printer types and a standard | |

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hand-held bar code reader to help expedite patient specimen identification.

The CELL-DYN 3200 and the CELL-DYN Ruby System are similar in that:

- Both systems consist of an Analyzer and Data Module a. housed in a single chassis with a standalone display.
- b. Both systems provide quantitation of the hemogram and automated WBC differential parameters in EDTAanticoagulated human whole blood specimens.
- Both systems will accept specimens presented C. automatically by the autoloader or manually presented by the operator.
- d. Both systems utilize laser optical scatter (WBC, RBC and PLT) and optical absorbance methods (HGB) using a Helium Neon laser.
- e. Both systems utilize a single step offline staining procedure for reticulocyte analysis.
- f. Both systems provide Dispersional Data Alerts, Suspect Parameter Messages, and Suspect Population Flags to assist in data review.
- Both systems accept input from the keyboard and send g. data output to: video screen, hard drive, and printer; and both systems provide RS232 Interface to an on-line LIS as well as using microprocessors for systems control, data acquisition, and data analysis.
- h. Both systems utilize the same reagent formulations.
- i. Both systems have Moving Average Programs (X-B) for WBC, RBC parameters and the capability to download QC to media for online peer QC review.
- Both systems are able to search patient demographics. i.

The CELL-DYN Ruby System and the CELL-DYN 3200 System are different in that:

Similarities and Differences:

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- The CELL-DYN Ruby uses a Microsoft® Windows® a. XP operating system, while the CELL-DYN 3200 uses Microsoft® DOS operating system.
- b. The CELL-DYN Ruby incorporates a mouse for software navigation, a 17 inch touch sensitive LCD display, and a hand held barcode reader for patient and control identification, where the CELL-DYN 3200 does not have any of these options.
- The CELL-DYN Ruby has software wizards which ﻦ step users through less routinely performed processes, while the CELL-DYN 3200 does not have this feature.
- d. The CELL-DYN Ruby has a CD-ROM or DVD Drive that allows the installation of software, and online maintenance videos and online help manual, while the CELL-DYN 3200 uses a floppy disk drive to download and upload information and does not have the online help capability.
- The CELL-DYN Ruby includes the ability to have e. interactions and remote instrument monitoring through AbbottLink, while the CELL-DYN 3200 only acts as a passive communicator and provides number of cycles performed on the analyzer.
- The CELL-DYN Ruby uses an increased size f. configuration of WBC Lyse reagent when compared to the current CELL-DYN 3200 configuration.
- g. The CELL-DYN Ruby Quality Control Moving Average programs (X-B) has been expanded to include PLT and RETC parameters and is capable of downloading reticulocytes QC to media for online peer QC Review, while the CELL-DYN 3200 does not have the same QC capability for Reticulocytes.

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| | h. The CELL-DYN Ruby is able to search and filter the datalog and system log, while the CELL-DYN 3200 only searches patient demographics and does not have a system log. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | i. The CELL-DYN Ruby incorporates WOC and HGB reagent heaters to bring the reagents within a required temperature range while the CELL-DYN 3200 does not. |
| Equivalency Data: | The analysis above supports the claim that the CELL-DYN Ruby System is substantially equivalent to the CELL-DYN 3200 System.<br>Data on file at Abbott Laboratories consisting of background, carryover, imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity information shows performance to the manufacturer's specifications. |
| Conclusion: | The CELL-DYN Ruby System demonstrates substantial equivalence to the predicate device. |
| Truthful and Accurate Certification | A certification of the truthfulness and accuracy of the CELL-DYN Ruby System described in this submission is provided in Attachment I. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Michelle Roeding Section Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive Santa Clara, California 95054

JUL 1 0 2006

Re: k061667

Trade/Device Name: CELL-DYN RubyTM System Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential counter cell Regulatory Class: II Product Code: GKZ Dated: June 13, 2006 Received: June 14, 2006

Dear Ms. Roeding:

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,

Robert Beckerh

Robert L. Becker, Jr., MD, Pa 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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## Indications for Use

510(k) Number (if known): K061667

Device Name: ___________CELL-DYN RubyTM System

Indications for Use:

The CELL-DYN Ruby System is designed to analyze EDTA-anticoagulated blood and report the following hematological parameters:

| White Blood Cell Parameters | Red Blood Cell Parameters | Hemoglobin Parameters |
|--------------------------------------------|-----------------------------------------------|----------------------------------------------|
| WBC - White Blood Cell Concentration | RBC - Red Blood Cell Concentration | HGB - Hemoglobin Concentration |
| NEU - Neutrophil Absolute<br>Concentration | HCT - Hematocrit | MCH - Mean Cell Hemoglobin |
| %N - Neutrophil Percentage of WBC | MCV - Mean Cell Volume | MCHC - Mean Cell Hemoglobin<br>Concentration |
| LYM - Lymphocyte Absolute<br>Concentration | RDW - Red Cell Distribution Width | |
| %L - Lymphocyte Percentage of WBC | %R - Reticulocyte Percent | |
| MONO - Monocyte Absolute<br>Concentration | RETC - Reticulocyte Absolute<br>Concentration | |
| %M - Monocyte Percentage of WBC | | |
| EOS - Eosinophil Absolute<br>Concentration | | |
| %E - Eosinophil Percentage of WBC | | |
| BASO - Basophil Absolute<br>Concentration | | |
| %B - Basophil Percentage of WBC | | |
| Platelet Parameters | | |
| PLT - Platelet Concentration | | |
| MPV - Mean Platelet Volume | | |

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence OFCDRH, Offide of Device Evaluation (ODE)

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