VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST

K083294 · Nanosphere, Inc. · NUA · Jul 24, 2009 · Immunology

Device Facts

• Record ID: K083294
• Device Name: VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
• Applicant: Nanosphere, Inc.
• Product Code: NUA · Immunology
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Verigene®CFTR and Verigene®CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic devices used to genotype a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG) and the 2005 American College of Obstetricians and Gynecologists (ACOG). The Verigene®CFTR Nucleic Acid Test provides information intended to be used for carrier testing in adults of reproductive age and in confirmatory diagnostic testing of newborns and children. These tests are not indicated for use in fetal diagnostic or pre-implantation testing and not indicated for stand-alone diagnostic purposes and the results should be used in conjunction with other available laboratory and clinical information. Both tests are intended to be used on the Verigene System.

Device Story

Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests are qualitative in vitro diagnostic assays for genotyping CFTR gene mutations and variants. Input: genomic DNA isolated from human peripheral whole blood. Operation: automated nucleic acid testing system; detects specific mutations/variants associated with cystic fibrosis. Output: genotype results for the panel. Used in clinical laboratory settings by trained personnel. Results intended for use by clinicians in conjunction with other laboratory and clinical data to support carrier screening and diagnostic confirmation. Benefits: provides rapid, specific genetic information to assist in clinical decision-making for cystic fibrosis management and reproductive counseling.

Clinical Evidence

No clinical data provided in the summary document; device performance established via bench testing of analytical sensitivity and specificity for mutation detection.

Technological Characteristics

Qualitative genotyping assay using gold-labeled nanoparticle probes on a microarray. Signal amplification via silver deposition. Detection via light scattering photosensor. System: Verigene Processor and Reader. Connectivity: Closed system. Software: Embedded, integrated GUI. Materials: Single-use disposable cartridges.

Indications for Use

Indicated for carrier testing in adults of reproductive age and confirmatory diagnostic testing of newborns and children for CFTR gene mutations/variants. Not for fetal or pre-implantation testing; not for stand-alone diagnosis.

Regulatory Classification

Identification

The CFTR gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the CFTR gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation, or population screening.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

## JUL 8 4 2009

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Nanosphere, Inc. c/o Dr. Gregory W. Shipp Vice President, Medical and Regulatory Affairs and Quality Assurance 4088 Commercial Avenue Northbrook, IL 60062

#### Re: k083294

Trade/Device Name: Verigene® CFTR and Verigene® CFTR PolyT Nucleic Acid Test Regulation Number: 21 CFR 866.5900 Regulation name: CFTR (cystic fibrosis transmembrane conductance regulator) gene mutation detection system Regulatory Class: Class II Product Code: NUA Dated: June 19, 2009 Received: June 22, 2009

#### Dear Mr. Shipp,

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 (OS) 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

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Page 2 - Mr. Gregory Shipp

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 Part 801), please contact the Office or In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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

Cor 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): k083294

Device Names: Verigene® CFTR and Verigene® CFTR PolyT Nucleic Acid Tests

### Indications for Use:

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Prescription Use × (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use (21 CFR 801 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)

Reena Philip

For Maria Chao)

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k083294