CELLTRACKS AUTOPREP SYSTEM

K110406 · Veridex, LLC · NQI · Jan 20, 2012 · Immunology

Device Facts

• Record ID: K110406
• Device Name: CELLTRACKS AUTOPREP SYSTEM
• Applicant: Veridex, LLC
• Product Code: NQI · Immunology
• Decision Date: Jan 20, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6020
• Device Class: Class 2

Intended Use

The CellTracks® AutoPrep® 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 II®, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Device Story

CellTracks® AutoPrep® System is an automated laboratory instrument for sample preparation; processes whole blood samples using immunomagnetic reagents to capture and enrich target cells; applies labeling reagents to differentiate specific cell populations. Output consists of prepared samples ready for analysis via CellTracks Analyzer II®, flow cytometers, or microscopes. Used in clinical laboratory settings by trained laboratory personnel. Facilitates cell identification and enumeration; aids in diagnostic workflows by standardizing sample preparation; reduces manual handling variability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automated sample preparation system. Modification involves software/procedural update for daily cleaning (DCP). Fundamental technology unchanged from predicate. Conformance with 21 CFR 820.30 design control procedures.

Indications for Use

Indicated for metastatic breast, prostate, and colorectal cancer patients; clinical cut-off ≥ 5 CTCs for breast/prostate, ≥ 3 CTCs for colorectal.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Veridex, LLC c/o Jessica Shelffo Sr. Regulatory Affairs Associate 1001 US Highway 202 North Raritan, NJ 08869

JAN 2 0 2012

Re: k110406

Trade Name: CellTracks® AutoPrep® System Regulation Number: 21 CFR §866.6020 Regulation Name: Immunomagnetic circulating cancer cell selection and enumeration system Regulatory Class: II Product Code: NQI Dated: December 21, 2011 Received: December 22, 2011

Dear Ms. Shelffo:

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 for ass brior 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). and Occancer fore, market the device, subject to the general controls provisions of the Act. The I ou may, merely, mains 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 class II (Special Controls), 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 I hat FDA has made a determination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I could statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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Page 2 - Ms. Jessica Shelffo

medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you doesn't the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Reena Philip

Maria M. Chan, Ph.D. Yoth 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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## Indications for Use

510(k) Number (if known):

<110406

Device Name: CellTracks® AutoPrep® System

Indication For Use:

The CellTracks® AutoPrep® 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 II®, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

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Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110406

Veridex, LLC

CellTracks® AutoPrep® System

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