MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT

K052191 · Veridex, LLC · NQI · Oct 27, 2005 · Immunology

Device Facts

• Record ID: K052191
• Device Name: MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
• Applicant: Veridex, LLC
• Product Code: NQI · Immunology
• Decision Date: Oct 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6020
• Device Class: Class 2

Intended Use

The CellSearch™ Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.

Device Story

System uses immunomagnetic enrichment and fluorescence-based imaging to detect circulating tumor cells (CTC) in whole blood; input is 7.5 mL whole blood sample; process involves immunomagnetic capture of EpCAM+ cells followed by staining for CD45-, cytokeratin 8, 18, and 19+; CellTracks® AutoPrep System performs automated sample preparation; CellSpotter® Analyzer or CellTracks® Analyzer II performs imaging and enumeration; output is CTC count per 7.5 mL blood; used in clinical laboratory settings by trained technicians; results provided to physicians to assess prognosis in metastatic breast cancer patients; elevated CTC counts (≥5) correlate with shorter progression-free and overall survival; aids clinical decision-making regarding patient prognosis.

Clinical Evidence

Prospective multi-center trial (N=177) of metastatic breast cancer patients. Primary endpoints: Progression-Free Survival (PFS) and Overall Survival (OS). Patients with ≥5 CTCs/7.5 mL at baseline had significantly shorter median PFS (2.7 vs 7.0 months, p=0.0001) and OS (10.9 vs 21.9 months, p<0.0001). Follow-up measurements at 3-20 weeks confirmed predictive value. Multivariate Cox regression identified CTC count as a strong independent predictor of survival outcomes.

Technological Characteristics

Immunomagnetic-capture immunofluorescent detection system. Components: anti-EpCAM ferrofluid, anti-CK-PE, DAPI, anti-CD45-APC. Instrument: CellTracks® AutoPrep and CellTracks® Analyzer II (semi-automated fluorescence microscope). Connectivity: Standalone. Sterilization: Not specified. Software: Semi-automated image acquisition and gallery-based classification.

Indications for Use

Indicated for patients with metastatic breast cancer. Presence of CTCs (≥5 per 7.5 mL blood) is associated with decreased progression-free and overall survival. Used for monitoring disease progression and response to therapy.

Regulatory Classification

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.

Special Controls

The device is classified as Class II under regulation 21 CFR 866.6020 with special controls. The special control guidance document "Immunomagnetic Circulating Cancer Cell Selection and Enumeration System" is available at https://www.fda.gov/cdrh/oivd/guidance/1531.pdf

*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.

Reference Devices

• CellTracks® AutoPrep System
• CellSpotter® Analyzer
• CellTracks® Analyzer II
• CellSearch™ Circulating Tumor Cell Control Kit

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] or at its Internet address

[phone] 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

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5100(k) K052/91

neral Background and Regulatory Forms Confidential

Section I

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