CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

K022512 · Immunicon Corp. · GKH · Sep 30, 2002 · Hematology

Device Facts

• Record ID: K022512
• Device Name: CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
• Applicant: Immunicon Corp.
• Product Code: GKH · Hematology
• Decision Date: Sep 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5240
• Device Class: Class 1

Intended Use

The Immunicon CellPrep™ Sample Preparation System is a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Device Story

Semi-automated sample-handling instrument for clinical laboratories; processes anticoagulated whole blood. Principle of operation: immunomagnetic enrichment using ferrofluid conjugated with monoclonal antibodies. Ferrofluid particles attach to target cells; strong magnetic field isolates labeled cells to tube side; blood aspirated; magnetic field removed; cells resuspended in buffer. System performs red cell detection, plasma aspiration, and sample chamber filling; prompts user for reagent addition and mixing. Final output: enriched, processed sample ready for analysis by flow cytometry, fluorescent microscopy, or CellTracks™ Analyzer. Enables identification and enumeration of rare target cells; benefits include improved recovery of low-abundance cells from blood volumes.

Clinical Evidence

Clinical testing conducted at five sites by medical technicians/biologists. Demonstrated capability to recover small cell numbers (~950) from 7.5 ml blood. Average recovery rate: 74.2% to 86.5%; CV range for duplicate samples: 3.1% to 8.0%. Nonclinical testing showed sensitivity for recovering ~10 cells per 7.5 ml and linear recovery (50-200 cells) with a slope of 0.82.

Technological Characteristics

Semi-automated laboratory instrument. Ferrofluid-based immunomagnetic separation. Materials: magnetic core with protein layer and antibody coating. Standards: EN 60601-1-2 (EMC) and IEC 601010-2-101 (IVD safety). Connectivity: standalone. Power: electrical.

Indications for Use

Indicated for use in clinical laboratories and research institutions for the immunomagnetic capture, enrichment, and labeling of target cells from anticoagulated whole blood samples to facilitate subsequent identification and enumeration via flow cytometry, fluorescent microscopy, or the CellTracks™ Analyzer.

Regulatory Classification

Identification

An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

Predicate Devices

• Coulter Multi-O-Prep

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the Immunicon logo. The logo consists of a black circle with a white design inside, followed by the word "IMMUNICON" in large, bold letters. Below the word "IMMUNICON" is the phrase "INNOVATIVE TOOLS FOR CANCER RESEARCH" in smaller letters.

## 510(k) Summary

Image /page/0/Picture/3 description: The image shows a document with the text "Date prepared" followed by the date "7/24/02". The word "RECEIVED" is printed vertically on the document. The text "Jun. 30 11 11 A02" and "FDA/CDRH/ODE/DMC]" are also visible on the document.

This 510(k) summary is being submitted in accordance with the requireme 807.92 (c).

The assigned 510(k) number is KO22512

The submitter of this premarket notification is Immunicon Corporation, 3401 Masons Mill Road, Suite 100, Huntingdon Valley, PA 19006. The official correspondent is Peter J Scott, Vice President of Quality Assurance and Regulatory Affairs (215-830-0777 ext 235. fax [phone]).

The subject of this summary of Safety and Effectiveness is the Immunicon CellPrep™ Sample Preparation System. The predicate device is the Coulter Multi-O-Prep. The subject device is intended for use in traditional Clinical laboratories and Research Institutions. The common and classification name for this device is an Automated Blood Cell Diluting Apparatus.

The intended use for the Immunicon CellPrep™ Sample Preparation System is as a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

The CellPrep System is a semi-automated sample-handling instrument that starts with a tube of anticoagulated whole blood and delivers an enriched, processed sample that is ready to analyze by flow-cytometry, fluorescent microscopy or by the CellTracks™ Analyzer. The CellPrep™ System performs several steps, including red cell detection, plasma aspiration and filling of a sample chamber or test tube. The user is prompted to perform various operations such as reagent addition and mixing. The principal of operation relates to the addition of a ferrofluid, which has been conjugated with monoclonal antibodies that act with the system to magnetically separate the cells of interest and in subsequent steps, within the system, to add fluorescence-labeled monoclonals to further differentiate the captured cells. The first reagent added is

> Page 1 of 2 Section 2

IMMUNICON® CORPORATION ▪ 3401 MASONS MILL ROAD, SUITE 100 ▪ HUNTINGDON VALLEY, PA 19066-3574 PHONE: [phone] ■ FAX [phone] E-MAIL: [e-mail] ■ WEBSITE: www.immunicon.com

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image is a logo for Immunicon. The logo consists of a black circle on the left with a white design inside, followed by the word "IMMUNICON" in large, bold, black letters. Below the word "IMMUNICON" is the phrase "INNOVATIVE TOOLS FOR CANCER RESEARCH" in smaller, black letters.

ferrofluid, which consists of a magnetic core surrounded by a protein layer coated with antibodies for attachment to cells. Ferrofluid particles are colloidal and when mixed with a sample containing the target cells, they interact and attach to the target cells. The ferrofluid/sample mixture is placed in a strong magnetic field, which causes the labeled target cells to move to the side of the tube. The blood is aspirated, the magnetic field is removed and the cells are resuspended in a small volume of buffer and fluorescent reagents are added for the identification and enumeration of the target cells. Another magnetic separation step and resuspension is performed and the sample is now ready for analysis. The immunomagnetic enrichment process is the new technology but does not raise any new issues of safety and effectiveness.

Discussion of Clinical and nonclinical testing

Clinical testing was performed at five clinical sites by Medical technicians or degreed biologists. The clinical trial proved that the CellPrep™ Sample Preparation system was capable of removing small numbers of cells (~950) from a 7.5 ml volume of blood. The average recovery rate was 74.2% to 86.5% with a CV range for duplicate samples of 3.1% to 8.0%.

Nonclinical testing indicated a sensitivity of being able to recover cells at very low levels of approximately 10 cells per a 7.5 ml volume of blood and a linear recovery of cells through the range of 50 to 200 cells with a slope of 0.82 through the zero axes in a 7.5 ml sample of blood.

The CellPrep™ Sample Preparation System was tested and met the applicable requirements of EN 60601-1-2 (1993) "Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility requirements and Tests" and IEC 601010-2-101 "Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment".

Section 2

Page 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. 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 a bird-like figure with three curved lines representing its wings or feathers.

SEP 3 0 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Peter Scott Vice President of Quality Assurance and Regulatory Affairs Immunicon Corporation 3401 Masons Mill Road Huntingdon Valley, Pennsylvania 19006

Re: k022512

Trade/Device Name: Immunicon CellPrep™ Sample Preparation System Regulation Number: 21 CFR § 864.5240 Regulation Name: Automated Blood Cell diluting apparatus Regulatory Class: I Product Code: GKH Dated: July 29, 2002 Received: July 30, 2002

Dear Mr. Scott:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

## Page 2

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" (21CFR 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 Autman

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

{4}------------------------------------------------

Page ( of /

510(k) Number (if known): K022517

Device Name: CellPrep Sample Preparation SYSTEM

Indications For Use:

The Immunicon CellPrep™ Sample Preparation System is a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ougheline Fantoli

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

(Optional Format 3-10-98)