(62 days)
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.
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.
The provided text describes the Immunicon CellPrep™ Sample Preparation System and summarizes the testing performed to demonstrate its safety and effectiveness. However, it does not explicitly present a table of acceptance criteria or a detailed, structured study report in the format requested. Instead, it provides a narrative summary of performance findings.
Based on the provided text, here's an attempt to extract and infer the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a separate, defined list. However, we can infer the performance targets/criteria from the reported results.
| Performance Metric | Implied Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Cell Recovery (Clinical) | High recovery rate for small cell numbers (e.g., ~950 cells from 7.5 ml blood) | Average recovery rate was 74.2% to 86.5% for ~950 cells from 7.5 ml blood. |
| Precision (Clinical) | Reproducible results for duplicate samples | CV range for duplicate samples of 3.1% to 8.0%. |
| Sensitivity (Nonclinical) | Ability to recover cells at very low levels | Able to recover cells at approximately 10 cells per a 7.5 ml volume of blood. |
| Linearity (Nonclinical) | Linear recovery across a range of cell concentrations | 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. |
| Electromagnetic Compatibility (Nonclinical) | Compliance with EN 60601-1-2 (1993) | Tested and met the applicable requirements of EN 60601-1-2 (1993). |
| Safety Electrical Equipment (Nonclinical) | Compliance with IEC 601010-2-101 | Tested and met the applicable requirements of IEC 601010-2-101. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The text states, "Clinical testing was performed at five clinical sites." It mentions the device was "capable of removing small numbers of cells (~950) from a 7.5 ml volume of blood" and that the CV range was for "duplicate samples." However, it does not explicitly state the total number of patient samples, runs, or analyses conducted within the clinical trial. It only refers to "small numbers of cells (~950)". For non-clinical testing, it mentions "very low levels of approximately 10 cells" and "range of 50 to 200 cells" in a 7.5ml sample, but again, no specific sample size (i.e., number of spiked samples or replicates) is provided.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: "Clinical testing was performed at five clinical sites" implies a prospective study, where samples were processed and analyzed as part of the trial. The term "nonclinical testing" typically refers to laboratory-based, controlled studies, which are also generally prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The text states, "Clinical testing was performed at five clinical sites by Medical technicians or degreed biologists." While these individuals performed the testing, the method and number of experts establishing the ground truth (e.g., the true cell count before processing, or an independent verification of captured cells) are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The text does not describe any adjudication process for the results obtained.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The Immunicon CellPrep™ Sample Preparation System is described as a "semi-automated sample-handling instrument" designed to prepare samples for analysis by "flow cytometers or microscopes." It processes blood and delivers an enriched sample. It is not an AI-powered diagnostic tool for image interpretation or diagnosis that would typically be evaluated in an MRMC study involving human readers with and without AI assistance. Therefore, an MRMC study as described, and its effect size, are not applicable and were not performed for this device type based on the provided text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "semi-automated sample-handling instrument." It performs physical steps to prepare blood samples. While it has automated components, it is not an "algorithm only" device in the sense of an AI model. The performance metrics (recovery, precision, sensitivity, linearity) are for the device's ability to process samples, which is inherently a "standalone" performance evaluation of the instrument itself in its intended function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for cell recovery and linearity studies would have been established by:
- Known input concentrations: For nonclinical sensitivity and linearity testing, cells are typically spiked into samples at known concentrations.
- Baseline measurements or reference methods: For clinical recovery, it would involve knowing the initial cell count in the 7.5 ml blood volume before the CellPrep device processes it. This might be done using a highly accurate reference method or manual counting.
The document does not explicitly state the exact method used, but for "recovery" and "sensitivity" of a sample preparation system, the ground truth is generally a quantified, validated initial cell count or concentration.
8. The sample size for the training set
The device is a sample preparation instrument. It does not use machine learning or AI models that require a "training set" in the typical sense of AI/ML software development. Therefore, this concept is not applicable to the Immunicon CellPrep™ Sample Preparation System as described.
9. How the ground truth for the training set was established
As explained in point 8, the concept of a "training set" for an AI/ML model does not apply to this device.
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510(k) Summary
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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
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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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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
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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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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)
§ 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.