(301 days)
The intended use for the Immunicon CellTracks™ System is as a general-purpose laboratory bench top scanning cytometer designed to enumerate fluorescently labeled leukocyte subsets that are immuno-magnetically selected and aligned. The system is for in vitro diagnostic use.
To enumerate fluorescently labeled leukocyte subsets that are immuno-magnetically selected and aligned.
The CellTracks Analyzer is used in conjunction with reagents containing ferrofluids and fluorescent conjugates. Depending on the application, samples may be prepared manually or using the CellTracks AutoPrep Sample Preparation System. Ferrofluid consists of a magnetic core surrounded by a polymeric layer coated with antibodies for capturing cells. Ferrofluid particles are colloidal (25-100 nanometers in radius) and when mixed with a sample containing target cells, the antibodies bound to the ferrofluid bind the associated antigens to the target cells. Fluorescent reagents are added for the identification and the enumeration of the target cells. The ferrofluid/sample mixture is placed in a magnetic field (Magnest), to select and align the labeled target cells. The Magnest, containing the fluorescence-labeled magnetically aligned target cells, is placed on the CellTracks analyzer and is ready for analysis.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| CD4 Slope (vs. predicate) | Close to 1.0 | 0.95 |
| CD4 R² (vs. predicate) | High, close to 1.0 | 0.9802 |
| CD3 Slope (vs. predicate) | Close to 1.0 | 0.77 |
| CD3 R² (vs. predicate) | High, close to 1.0 | 0.9375 |
| Linearity | Not explicitly stated but expected to be broad | 0 to 2,000 cells/ul |
| CD3 Normal Control Within-run CV | Not explicitly stated but expected to be low | 3.68% to 4.34% |
| CD3 Low Control Within-run CV | Not explicitly stated but expected to be low | 3.89% to 6.60% |
| Interference from Lipids | No adverse affect | No adverse affect up to 5,000 mg/dL |
| Interference from Hematocrits | No adverse affect | No adverse affect from 43.3% to 76.2% |
| Interference from Platelet Counts | No adverse affect | No adverse affect from 210 x 10² to 2,040 x 10² |
| Interference from WBC Counts | No adverse affect | No adverse affect from 4.1 x 10³ to 25.0 x 10³ |
| Interference from Free Hemoglobin | No adverse affect | No adverse affect from 10.3 to 12.4 g/dL |
| Electrical Safety (IEC 61326-1998, IEC 601010-2-101) | Met requirements | Met requirements |
| Laser Safety (21 CFR Part 1040.10) | Met requirements | Met requirements |
*Note: The document
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NOV 2 4 2003
510(k) Summary
Date prepared 1/21/03.
This 510(k) summary is being submitted in accordance with the requirements of 807.92 (c).
The assigned 510(k) number is_ Ke3 0263 ======================================================================================================================================
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 subjects of this summary of Safety and Effectiveness are the Immunicon CellTracks™ System. The predicate devices are the Becton Dickinson FACSCalibur System. The subject devices are intended for use in traditional Clinical laboratories and Research Institutions. The common and classification name for this instrument is an Automated Differential Cell Counter.
The intended use for the Immunicon CellTracks™ System is as a general-purpose laboratory bench top scanning cytometer designed to enumerate fluorescently labeled leukocyte subsets that are immuno-magnetically selected and aligned. The system is for in vitro diagnostic use.
The CellTracks Analyzer is used in conjunction with reagents containing ferrofluids and fluorescent conjugates. Depending on the application, samples may be prepared manually or using the CellTracks AutoPrep Sample Preparation System. Ferrofluid consists of a magnetic core surrounded by a polymeric layer coated with antibodies for capturing cells. Ferrofluid particles are colloidal (25-100 nanometers in radius) and when mixed with a sample containing target cells, the antibodies bound to the ferrofluid bind the associated antigens to the target cells. Fluorescent reagents are added for the identification and the enumeration of the target cells. The ferrofluid/sample mixture is placed in a magnetic field (Magnest), to select and align the labeled target cells.
Section 2 Page 1 of 2
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The Magnest, containing the fluorescence-labeled magnetically aligned target cells, is placed on the CellTracks analyzer and is ready for analysis.
Discussion of Clinical and nonclinical testing
A Clinical study was performed using blood samples from 149 HIV+ patients and 150 samples obtained from normal donors to determine CD3 and CD4 lymphocyte counts. The samples were obtained from three geographically dispersed sites and Medical Technologists performed testing according to NCCLS EP9-A. Method Comparison and Bias Estimation Using Patient Samples. The samples were analyzed using three CellTracks™ Analyzers and compared with results of the Becton Dickinson FACSCalibur™ System. Results of the testing indicated a slope of 0.95 and an R2 of 0.9802 for CD4 and a slope of 0.77 and an R2 of 0.9375 for CD3.
Nonclinical testing included linearity, precision, and the affects of interfering substances. The CellTracks Analyzer demonstrated linearity from 0 to 2,000 cells/ul. A 20-day precision study was performed according to NCCLS Guideline EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices using three CellTracks™ Analyzers and BD Multi-Check Controls. The normal CD3 control (1086 cells/ul) within-run CV's ranged from 3.68% to 4.34%. For the low CD3 control (505cells/ul), within run CV's ranged from 3.89% to 6.60%. The potential affects of interfering substances was tested using lipid levels from 0 to approximately 5,000 mg/dL. hematocrits from 43.3 to 76.2%, platelet counts from 210 x 102 to 2,040 x 102, white blood cell counts of 4.1 x 103 to 25.0 x 10 and free hemoglobin in plasma levels of 10.3 to 12.4 g/dL, none of the interfering substances utilized had an adverse affect on the CD3 or CD4 counts obtained.
The CellTracks™Analyzer was tested and met the applicable requirements of IEC 61326-1998 "Electrical Equipment for Measurement, Control and Laboratory Use -EMC Requirements 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". The CellTracks Analyzer meets the requirements of 21 CFR part 1040.10 laser products.
Section 2
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines representing movement or energy.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 4 2003
Mr. Peter Scott Vice President, Quality Assurance and Regulatory Affairs Immunicon Corporation 3401 Masons Mill Road, Suite 100 Huntingdon Valley, Pennsylvania 19006
K030263 Re:
Trade/Device Name: Immunicon CellTracks™ Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: January 24, 2003 Received: January 27, 2003
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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Immunicon CellTracks™ Analyzer Device Name:
Indications For Use:
To enumerate fluorescently labeled leukocyte subsets that are immuno-magnetically selected and aligned.
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Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) _\$\delta 3026}
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”