MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM

K080995 · Affymetrix, Inc. · NSU · Jul 30, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080995
• Device Name: MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
• Applicant: Affymetrix, Inc.
• Product Code: NSU · Clinical Chemistry
• Decision Date: Jul 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Intended Use

The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.

Device Story

The Affymetrix GeneChip Microarray Instrumentation System is a laboratory-based diagnostic tool used to analyze genetic material. It consists of the GeneChip 3000Dx scanner with an autoloader, the FS450Dx fluidics station, and GCOSDx software. The system processes hybridized GeneChip arrays by measuring fluorescence signals from labeled DNA and RNA targets. It is operated by trained laboratory personnel in a clinical environment. The output, consisting of fluorescence intensity data, is used by clinicians to assist in diagnostic decision-making related to genetic analysis. The system automates the scanning and fluidics processing steps, providing standardized measurements of hybridization signals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes GeneChip 3000Dx scanner, autoloader, and FS450Dx fluidics station. Operates via fluorescence detection of hybridized DNA/RNA targets on microarrays. Software-controlled instrumentation for clinical multiplex testing. Class II device under 21 CFR 862.2570.

Indications for Use

Indicated for measuring fluorescence signals of labeled DNA and RNA targets hybridized to GeneChip® arrays in a clinical laboratory setting.

Regulatory Classification

Identification

Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Submission Summary (Full Text)

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Food and Druq Administration 2098 Gaither Road Rockville MD 20850

## JUL 3 0 2008

Affymetrix, Inc. C/O Maureen J. Mende Director, Regulatory Affairs and Clinical Trials 3420 Central Expressway Santa Clara, CA 95051

Re: k080995

Trade/Device Name: Affymetrix Genechip Microarray Instrumentation System Regulation Number: 21CFR § 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: Class II Product Code: NSU Dated: July, 23 2008 Received: July 24, 2008

Dear Ms. Mende:

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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

510(k) Number (if known): k080995

Device Name: Affymetrix GeneChip® Microarray Instrumentation System Indication For Use:

The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.

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 (OVD)

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

510(k) K080995