CELLTRACKS AUTOPREP SYSTEM MODEL:9541

K100684 · Veridex, LLC · GKH · Aug 26, 2010 · Hematology

Device Facts

• Record ID: K100684
• Device Name: CELLTRACKS AUTOPREP SYSTEM MODEL:9541
• Applicant: Veridex, LLC
• Product Code: GKH · Hematology
• Decision Date: Aug 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5240
• Device Class: Class 1

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®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for invitro diagnostic use.

Device Story

CellTracks® AutoPrep® System is a laboratory instrument for automated processing of whole blood samples; utilizes immunomagnetic reagents to capture and enrich target cells; applies labeling reagents to differentiate cells; processes up to 8 samples per batch; performs red cell detection, plasma aspiration, and transfer to analysis cartridge; requires user-performed pre-processing (dilution, centrifugation); output is a prepared sample for analysis by CellTracks Analyzer II®, CellSpotter® System, flow cytometers, or microscopes; used in clinical laboratory settings by trained personnel; facilitates cell identification and enumeration; aids in diagnostic workflows.

Clinical Evidence

No clinical data. Performance verified via bench testing: 66 waste handling events validated decontamination efficacy (visual color change) and pressure safety. System performance verified by comparing two instruments in predicate vs. modified configurations using CellSearch® Circulating Tumor Cell Control kits; all results fell within expected ranges.

Technological Characteristics

Automated immunomagnetic separation instrument. Components: Bulk Fluid Module (waste, buffer, DI water, cleaning solution bottles), magnetic separation station, fluidics system. Materials: Kautex plastic bottles. Connectivity: Standalone laboratory instrument. Sterilization: Not specified. Software: Embedded firmware for process control.

Indications for Use

Indicated for use as a general purpose laboratory instrument to capture, enrich, and label target cells in whole blood samples for subsequent identification and enumeration via cell analyzers, flow cytometers, or microscopes.

Regulatory Classification

Identification

An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

Predicate Devices

• CellTracks™ AutoPrep System (k040077)

Submission Summary (Full Text)

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# Summary Information

AUG 2 6 2010

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: KJ00684

- 1. Submitter name, address, contact
Veridex, LLC 1001 U.S. Route 202 Raritan, NJ 08869 Contact Person: Sarah McManus

- Preparation Date 2.
- 3. Device name

Date 510(k) prepared: March 9, 2010

Trade or Proprietary Name: CellTracks® AutoPrep® System Common Name: Blood cell diluting equipment Classification Name: Automated Blood Cell Diluting Apparatus (21 CFR 864.5240, Product Code GKH)

- Predicate device 4.
The predicate device is the CellTracks® AutoPrep® System (K040077, March 12, 2004)

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### 5. Device Description

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. The CellTracks® AutoPrep® System processes up to 8 samples in a batch, performing all required process steps, including red cell detection, plasma aspiration and final transfer to the analysis cartridge. The user is prompted to perform various pre-processing operations such as dilution and centrifugation. Cell analyzers such as the CellTracks Analyzer II®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration following processing.

The AutoPrep® system uses a series of immunomagnetic separation procedures to isolate the cells of interest and to stain the cells with fluorescence-labeled monoclonal antibodies.

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

The CellTracks® AutoPrep® System (modified) is substantially equivalent to the CellTracks® AutoPrep® System (current -K040077: March 12, 2004). There has been no change to intended use, fundamental scientific technology, mode of operations, or specimen type/identification.

Changes from the predicate include:

- 1) New make and model of waste bottle accessory.
- Labeling changes associated with the accessory waste 2) bottle and the waste bottle handling procedure.

CellTracks® AutoPrep® System 510(k) Summary

Comparison to predicate 7. device

Device intended use

6.

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### 8. Conclusions

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 functional testing of the bulk fluid module as well as performance testing using quality control samples.

The information presented in the premarket notification provides a reasonable assurance that the CellTracks® AutoPrep® System (modified) is safe and effective for the stated intended use.

#### CellTracks® AutoPrep® System 510(k) Summary

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Veridex, LLC c/o Ms. Sarah McManus Manager, Regulatory Affairs 1001 US Highway 202 North Raritan, New Jersey 08869

AUG 2 6 2010

Re: k100684

Trade/Device Name: CellTracks® AutoPrep® System Regulation Number: 21 CFR 864.5240 Regulation Name: Automated blood cell diluting apparatus Regulatory Class: Class I Product Code: GKH Dated: July 23, 2010 Received: July 26, 2010

Dear Ms. McManus:

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 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Ms. Sarah McManus

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 809), please contact 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,

ie mchan

Maria M. Chan, Ph.D. Director, Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Device and Radiological Health

Enclosure

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K100684

## Indication for Use

AUG 2 6 2010

510(k) Number (if known):

K100684

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®, CellSpotter® System, 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)

is m chan

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

510(k) k 100 684

Veridex, LLC

CellTracks® AutoPrep® System

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