(77 days)
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No
The summary describes a kit for enumerating circulating tumor cells using specific markers and associated systems, but there is no mention of AI or ML in the intended use, device description, or other sections.
No
The device is used for the enumeration of circulating tumor cells (CTC) and is associated with prognosis, not for treatment or therapy.
Yes
The device is intended for the "enumeration of circulating tumor cells (CTC)" and states that the "presence of CTC... is associated with decreased progression free survival and decreased overall survival", implying it provides information for diagnosis or prognosis related to cancer.
No
The device description is not found, but the intended use clearly describes a "Kit" and mentions "whole blood" and "7.5 mL of blood," indicating a physical component for sample collection and processing, not a software-only device. It also mentions specific hardware systems (CellTracks® AutoPrep System, CellSpotter® Analyzer or CellTracks® Analyzer II) used in conjunction with the kit.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "enumeration of circulating tumor cells (CTC) of epithelial origin... in whole blood". This involves testing a biological sample (whole blood) outside of the body to obtain information about a patient's health status (presence and number of CTCs). This is a core characteristic of an IVD.
- Sample Type: The device analyzes "whole blood," which is a biological specimen.
- Purpose: The purpose is to detect and quantify specific markers (CD45-, EpCAM+, cytokeratin 8 & 18+, and/or cytokeratin 19+) within the blood sample to identify and count CTCs. This information is used to assess the patient's prognosis in metastatic breast cancer.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The CellSearch™ Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+ and cytokeratin 8 & 18+, and/or cytokeratin 19+) in whole blood in conjunction with the CellTracks® AutoPrep System, the CellSpotter® Analyzer or CellTracks® Analyzer II, and the CellSearch™ Circulating Tumor Cell Control Kit.
The presence of CTC in the peripheral blood, as detected by the CellSearch™ Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. A CTC count of 5 or more per 7.5 mL of blood generally is predictive of shorter progression free survival and shorter overall survival.
Product codes
NQI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
(a)
Identification. An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.
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Image /page/0/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 7 2005
Veridex, LLC. c/o Ms. Debra J. Rasmussen Worldwide Executive Director Regulatory and Quality Affairs 33 Technology Dr. Warren, NJ 07059
Re: K052191
Trade/Device Name: CellSearch™ Circulating Tumor Cell Kit (Epithelial) Regulation Number: 21 CFR 866.6020 Regulation Name: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System Regulatory Class: Class II Product Code: NQI Dated: August 10, 2005 Received: August 11, 2005
Dear Ms Rasmussen:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your boom in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass succed in 28, 1976, the enactment date of the Medical Device Amendments, or to devices that prior with , 20, 1978, as cordance 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 n your de fiel 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 Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso oc advised that 2 a received 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 idoceming (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 Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally prematies nedicate 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), please contact the Office of Compliance at (240) 276-0131. 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
(201) 115 0977 6.da.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., M.D., PhD 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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Veridex LLC CellSearch™ Circulating Tumor Cell Kit
Indications for Use
510(k) Number (if known): K052191
Device Name: CellSearch™ Circulating Tumor Cell Kit
Indications for Use:
The CellSearch™ Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+ and cytokeratin 8 & 18+, and/or cytokeratin 19+) in whole blood in conjunction with the CellTracks® AutoPrep System, the CellSpotter® Analyzer or CellTracks® Analyzer II, and the CellSearch™ Circulating Tumor Cell Control Kit.
The presence of CTC in the peripheral blood, as detected by the CellSearch™ Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. A CTC count of 5 or more per 7.5 mL of blood generally is predictive of shorter progression free survival and shorter overall survival.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C) -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
ffice of In Vitro Diagnostic Device valuation and Safety
000004
5100(k) K052/91
neral Background and Regulatory Forms Confidential
Section I
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