(58 days)
The intended use for the Immunicon CellTracks™ AutoPrep System is as a generalpurpose 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, CellSpotter™ System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
The CellTracks™ AutoPrep System is an 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, CellSpotter™ System or by the CellTracks™ Analyzer. The AutoPrep System performs several steps, including red cell detection, plasma aspiration and filling of a sample chamber or test tube. 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 fluorescencelabeled 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 immunomagnetic enrichment process is the new technology but does not raise any new issues of safety and effectiveness.
The provided document is a 510(k) summary for the Immunicon CellTracks™ AutoPrep System. It does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria in the context of an AI/ML medical device, as the prompt's structure implies. This device is a sample-handling instrument for in vitro diagnostic use, not an AI-based system.
However, I can extract the relevant performance data that was collected as part of the 510(k submission.
Here's an analysis based on the information provided, framed to best fit the request, while acknowledging the limitations of the document's content for an AI/ML context:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format with predefined numerical targets. Instead, it describes performance characteristics observed during clinical and non-clinical testing. I will present the reported performance as if these were the metrics assessed.
The document discusses two main types of studies: a precision study and a method comparison study.
| Performance Metric | Reported Device Performance |
|---|---|
| Precision Study (Control Cells) | |
| 38 cell spike level CV | 16.8% |
| 264 cell spike level CV | 11.72% |
| Nonclinical Testing | |
| Sensitivity (lowest cell recovery) | Approximately one cell per 7.5 ml whole blood |
| Linear Recovery Range | 2 to 906 cells |
| Linear Recovery Slope | 1.0221 |
| Linear Recovery r-value | 0.9946 |
| Method Comparison (vs. Predicate) | |
| Correlation Coefficient | 0.99 |
| Slope | 1.0935 |
| Intercept | 4.0344 |
| r-value | 0.9801 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states a "20 day precision study" was performed and a "method comparison was performed." It does not explicitly state the number of samples or patients used in these studies. The precision study implies repeated measurements over 20 days.
- Data Provenance: Clinical testing was performed at "three clinical sites." The document does not specify the country of origin, but given the FDA submission, it's highly likely to be within the United States. The studies are prospective in nature, as they involve performing tests with the device to evaluate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation. The studies are technical performance evaluations of an automated sample preparation system. The "ground truth" for the precision study would be the known spike levels of control cells, and for the method comparison, it would be the results obtained by the predicate device. Therefore, no external experts were explicitly mentioned for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The studies described are analytical performance evaluations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI/ML diagnostic device; it's an automated sample preparation system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and was not conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in the sense that the performance evaluations (precision, sensitivity, linearity, method comparison) assess the device's technical capabilities as a standalone automated system. There's no "human-in-the-loop" component for the sample preparation itself, although subsequent analysis of the processed samples would involve human operators and/or other analytical instruments.
7. Type of Ground Truth Used
- Precision Study: The ground truth for the precision study was based on "control cells" at "spike levels" (38 cells and 264 cells). This implies a known, controlled input to assess reproducibility.
- Nonclinical Testing (Sensitivity, Linearity): The ground truth for sensitivity and linearity was derived from known cell counts introduced into the system to determine its ability to detect and accurately quantify them.
- Method Comparison: The ground truth for the method comparison was the results obtained from the "predicate device." This establishes a comparative baseline against an already legally marketed device for the same intended use.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device operates based on pre-programmed protocols and immunomagnetic separation principles, not on learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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mar 1 2 2004
510(k) Summary
Date prepared: January 8, 2004
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92 (c).
The assigned 510(k) number is 1040077
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 CellTracks™ AutoPrep System. The predicate device is the Immunicon CellPrep™ Sample Preparation system. 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 CellTracks™ AutoPrep System is as a generalpurpose 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, CellSpotter™ System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
The CellTracks™ AutoPrep System is an 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, CellSpotter™ System or by the CellTracks™ Analyzer. The AutoPrep System performs several steps, including red cell detection, plasma aspiration and filling of a sample chamber or test tube. 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 fluorescencelabeled monoclonals to further differentiate the captured cells. The first reagent added is
Section 2
Page 1 of 2
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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
Medical or Laboratory Technicians performed clinical testing at three clinical sites. The Clinical trial consisted of performing a 20 day precision study according to NCCLS "EP5-A Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline". The Clinical trial indicated that the CellTracks™ AutoPrep System was capable of removing small numbers of control cells reproducibly from 7.5 ml of whole blood (38 cell spike level CV = 16.8, 264 spike level CV = 11.72).
Nonclinical testing indicated a sensitivity of being able to recover cells at very low levels at approximately one cell per a 7.5 ml volume of whole blood and a linear recovery range from 2 to 906 cells with a slope of 1.0221 and an r = 0.9946. A method comparison was performed comparing the AutoPrep system to the predicate device according to NCCLS "EP9-A Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline" The results of the comparison showed a correlation coefficient of 0.99, a slope of 1.0935 with an intercept of 4.0344 and an r of 0.9801.
The CellTracks AutoPrep™ System was tested and met the requirements of EN 61326-1, meets class A, conforms to EU EMC Directive. Tested to FCC CFR 47, Part 15, subpart B, meets Class A. Tested to UL61010A, CSA C22.2 No. 1010-1 and EN61010. UL listed.
Section 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
MAR 1 2 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Peter J. Scott Vice President of Quality Assurance and Regulatory Affairs Immunicon Corporation 3401 Masons Mill Road Huntingdon Valley, Pennsylvania 19006
Re: K040077
Trade/Device Name: Immunicon CellTracksTM AutoPrep System Regulation Number: 21 CFR § 864.5240 Regulation Name: Automated blood cell diluting apparatus Regulatory Class: I Product Code: GKH Dated: January 8, 2004 Received: January 14, 2004
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 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Joseph L. Aralett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page / of /
510(k) Number (if known): K040077
Device Name: CellTRacks AutoPRe
Indications For Use:
The intended use for the Immunicon CellTracks™ AutoPrep System is as a generalpurpose 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, CellSpotter™ System, 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)
VIN vitro diagnostic use
Josephine Bautista
prescriptions use.
(Optional Format 3-10-98)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safet
510(k) K040077
§ 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.