CELLTRACKS AUTOPREP SYSTEM

K122821 · Veridex, LLC · NQI · Dec 13, 2012 · Immunology

Device Facts

• Record ID: K122821
• Device Name: CELLTRACKS AUTOPREP SYSTEM
• Applicant: Veridex, LLC
• Product Code: NQI · Immunology
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6020
• Device Class: Class 2

Intended Use

The CELLTRACKS® AUTOPREP® System is a laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS ANALYZER II® may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Device Story

Laboratory instrument for processing whole blood samples; utilizes immunomagnetic separation to capture and enrich target cells; performs automated steps including red cell detection, plasma aspiration, and transfer to analysis cartridge; requires user-performed pre-processing (dilution, centrifugation); stains cells with fluorescence-labeled monoclonal antibodies; used in clinical laboratories by trained personnel; output consists of processed samples in cartridges for subsequent identification and enumeration by CELLTRACKS ANALYZER II®; modification to pipetting probe reduces carryover risk; aids in clinical assessment of circulating tumor cells.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical functional testing, including reagent probe performance equivalence, CTC spike level characterization (carryover assessment), run-to-run carryover characterization, and reliability/life testing.

Technological Characteristics

Automated sample preparation system. Modification: pipetting probe with extrude-honed ID and Teflon-coated ID/OD. Fundamental scientific technology unchanged from predicate. No changes to assay detection.

Indications for Use

Indicated for use in laboratory settings to capture, enrich, and label target cells in whole blood samples for subsequent identification and enumeration via the CELLTRACKS ANALYZER II®.

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.

Predicate Devices

• CELLTRACKS® AUTOPREP® System (K110406)

Submission Summary (Full Text)

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Ki22821

## 8.0 510(K) SUMMARY

DEC 1 3 2012

1 -

| Submitter's Name | Veridex, LLC |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 1001 US Highway 202<br>Raritan, NJ 08869-0606 |
| Telephone Number<br>Fax Number | 908-927-4947<br>908-526-5059 |
| Contact Person | Kimberly Prescott, Associate Director, Global Regulatory Affairs |
| Date: | December 6, 2012 |
| Name of the Device | CELLTRACKS® AUTOPREP® System |
| Common or Usual<br>Name | Automated Blood Cell Diluting Apparatus |
| | Name: Immunomagnetic circulating cancer cell selection and enumeration<br>system |
| Classification Name | Device Class: II |
| | Product Code: NQI |
| | Regulation Number: 21 CFR 866.6020 |
| Performance Standards | There are no performance standards promulgated for this device. |
| Indications for Use | The CELLTRACKS® AUTOPREP® System is a laboratory instrument<br>used with immunomagnetic reagents that capture and enrich target cells,<br>and labeling reagents that differentiate cells in whole blood.<br>The CELLTRACKS ANALYZER II® may be used for cell identification<br>and enumeration. The system is for in vitro diagnostic use. |
| | CELLTRACKS® AUTOPREP® System |
| Identification of the<br>Legally Marketed<br>Device<br>(Predicate Device) | Name: Immunomagnetic circulating cancer cell selection and enumeration<br>system<br>Device Class: II<br>Product Code: NQI<br>Regulation Number: 21 CFR 866.6020 |

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## 510(k) Summary, continued

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| Device Description | The CELLTRACKS® AUTOPREP® System is a general purpose<br>laboratory instrument used with immunomagnetic reagents that capture<br>and enrich target cells, and labeling reagents that differentiate cells in<br>whole blood. The CELLTRACKS® AUTOPREP® System processes<br>up to 8 samples in a batch, performing all required process steps,<br>including red cell detection, plasma aspiration and final transfer to the<br>analysis cartridge. The user is prompted to perform various pre-<br>processing operations such as dilution and centrifugation. Cell<br>analyzers such as the CELLTRACKS ANALYZER II® may be used<br>for cell identification and enumeration following processing.<br>The CELLTRACKS® AUTOPREP® system uses a series of<br>immunomagnetic separation procedures to isolate the cells of interest<br>and to stain the cells with fluorescence-labeled monoclonal antibodies. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate Device | The CELLTRACKS® AUTOPREP® System (modified) is<br>substantially equivalent to the CELLTRACKS® AUTOPREP®<br>System (current - K110406, January 20, 2012). There has been no<br>change to intended use, fundamental scientific technology, mode of<br>operations, or specimen type/identification.<br>The only change from the predicate device and subject of this Special<br>510(k) is a modification to the pipetting probe to reduce the potential<br>for carryover, and a label change to the CELLTRACKS®<br>AUTOPREP® System labeling to change the caution about carryover<br>from circulating tumor cell (CTC) samples when containing 5,000<br>CTCs or greater per 7.5mL of blood. |
| Description of Testing | Non-clinical testing for the CELLTRACKS® AUTOPREP® System<br>functional testing included:<br>• New reagent probe versus current reagent probe assay<br>performance equivalence<br>• CTC (circulating tumor cell) spike level characterization of the<br>new probe (tumor cell carryover and control cell carryover)<br>• Run to Run carryover characterization<br>• Reliability/Life testing |

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Image /page/2/Figure/0 description: The image shows the words "Conclusion of Testing" in a large, bold font. The text is located on the left side of the image. The background of the image is white with some light gray spots.

The information presented in the premarket notification demonstrates that the performance of the CELLTRACKS® AUTOPREP® System (modified) is substantially equivalent to the predicate device.

Equivalence was demonstrated through non-clinical functional testing for the modified device. The information presented in the premarket notification provides a reasonable assurance that the CELLTRACKS® AUTOPREP® System (modified) is as safe and effective as the predicate device for the stated intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

### Letter Date: December 13, 2012

Veridex, LLC C/O Ms. Kimberly Prescott. 1001 US Highway 202 Raritan, NJ 08869-1424

| Re: 510(k) Number: | k122821 |
|--------------------|------------------------------------------------------------------|
| Trade/Device Name: | CELLTRACKS AUTOPREP® System |
| Regulation Number: | 21 CFR 866.6020 |
| Regulation Name: | Immunomagnetic circulating cancer cell selection and enumeration |
| | system |
| Regulatory Class: | Class II |
| Product Code: | NQI |
| Dated: | November 8, 2012 |
| Received: | November 9, 2012 |

Dear Ms. Prescott:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Ms. Kimberly Prescott

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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 -S

for

Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

#### 510(k) Number (if known): K122821

### Device Name: CELLTRACKS® AUTOPREP® System

### Indications for Use:

The CELLTRACKS® AUTOPREP® System is a laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS ANALYZER II® may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510K K122