(62 days)
Coulter Multi-O-Prep
Not Found
No
The description focuses on the physical and chemical processes of magnetic separation and reagent addition, with no mention of AI or ML algorithms for data analysis, image processing, or decision-making within the device's operation.
No
The device is described as a "general-purpose laboratory instrument" for "in vitro diagnostic use" to prepare samples for analysis, not to directly treat or diagnose a medical condition.
No
The device is a sample preparation system used to enrich and process target cells from whole blood. It does not perform the final cell identification or enumeration, which are steps typically associated with diagnosis. The processed sample is then ready for analysis by other devices like cell analyzers, flow cytometers, or microscopes.
No
The device description clearly outlines a "semi-automated sample-handling instrument" that performs physical steps like aspiration, filling, and magnetic separation, indicating it is a hardware device with potentially integrated software for control.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The system is for in vitro diagnostic use."
N/A
Intended Use / 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.
Product codes
GKH
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
traditional Clinical laboratories and Research Institutions.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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".
Key Metrics
average recovery rate was 74.2% to 86.5% with a CV range for duplicate samples of 3.1% to 8.0%.
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.
Predicate Device(s)
Coulter Multi-O-Prep
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5240 Automated blood cell diluting apparatus.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
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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 215-830-0751).
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: 215-830-0777 ■ FAX 215-830-0751 E-MAIL: immunicon@immunicon.com ■ WEBSITE: www.immunicon.com
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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
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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.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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)