CYTOVISION FOR CEP XY

K042542 · Applied Imaging Corp. · NTH · Jan 10, 2005 · Immunology

Device Facts

• Record ID: K042542
• Device Name: CYTOVISION FOR CEP XY
• Applicant: Applied Imaging Corp.
• Product Code: NTH · Immunology
• Decision Date: Jan 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.4700
• Device Class: Class 2

Intended Use

The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. CytoVision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy. This particular CytoVision software application is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer’s Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.

Device Story

CytoVision is an automated scanning microscope and image analysis system used in clinical laboratory settings. It accepts standard microscope slides containing interphase and metaphase nuclei as input. The system utilizes brightfield and fluorescent microscopy to locate nuclei; it performs high-magnification capture and analysis of interphase nuclei specifically for CEP XY DNA probes. The device produces analyzed images and data to assist clinicians in chromosomal analysis. By automating the identification and assessment of CEP XY signals, the system aids in evaluating bone marrow transplant success in opposite-sex patients. The output is reviewed by laboratory professionals to support clinical decision-making regarding transplant status.

Clinical Evidence

No clinical data provided; device is an automated scanning and analysis system for in vitro diagnostic use.

Technological Characteristics

System includes Intel-based PC (Windows), motorized microscope with brightfield/fluorescence, dichroic filters, Coolsnap CCD camera, motorized stage, and image acquisition board. Objectives: 20x, 40x, 60x, 100x. Connectivity: standalone workstation. Software: image analysis algorithm for FISH signal enumeration. Calibration: SPOT and pre-scan calibration for spatial/stage mapping.

Indications for Use

Indicated for use as an aid in chromosomal analysis, specifically for assessing bone marrow transplantation effectiveness in opposite-sex transplants by analyzing interphase nuclei using CEP XY probes.

Regulatory Classification

Identification

An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.

Special Controls

The device is classified as Class II under regulation 21 CFR 866.4700 with special controls. The special control guidance document " Class II Special Controls Guidance Document: Automated Fluorescence in situ Hybridization (FISH) Enumeration Systems" is available at www.fda.gov/cdrh/oivd/guidance/1550.pdf.

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescence*in situ* Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the 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

AUG 26 2011

Applied Imaging Corp c/o Ms. Diane Day Vice President, Regulatory Affairs. Clinical and Quality 120 Baytech Drive San Jose, CA 95134-2302

Re: k042542

Trade/Device Name: Applied Imaging Cyto Vision CEP XY Regulation Number: 21 CFR 866.4700 Regulation Name: Automated Fluorescent In Situ Hybridization (FISH) Enumeration Systems Regulatory Class: Class II Product Code: JOY Date: December 21, 2004 Received: December 22, 2004

Dear Ms. Day:

This letter corrects our substantially equivalent letter of January 10, 2005.

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 of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the

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Page 2 - Ms. Diane Day

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,

Mana M. Chen

Maria M. Chan, Ph.D. 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): k042542

Device Name: CytoVision™ CEP XY

Indications For Use:

The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.

This particular CytoVision software application is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.

Prescription Use (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)

Mana Chow
Division Sign-Off

Office of in Vitro Diagnos Device Evaluation and Safe

510(4) K042542

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