RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

K071867 · Paragondx, LLC · ODV · Apr 28, 2008 · Hematology

Device Facts

• Record ID: K071867
• Device Name: RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
• Applicant: Paragondx, LLC
• Product Code: ODV · Hematology
• Decision Date: Apr 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The Rapid Genotyping Assay – CYP2C9 & VKORC1 is intended to be used as an in vitro diagnostic test kit that detects the presence of CYP2C9 *2 and *3 and VKORC1 1173 C>T alleles. This test is for use with EDTA-anticoagulated whole blood samples. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients with greater risk for warfarin sensitivity. For Prescription Use Only. The information provided from this test may supplement therapeutic decision-making and should only be used in conjunction with routine monitoring by a physician. Clinicians should use professional judgment in the interpretation of results from this type of test.

Device Story

In vitro diagnostic test kit; detects specific genetic alleles (CYP2C9 *2, *3 and VKORC1 1173 C>T) in EDTA-anticoagulated whole blood samples. Used by clinical laboratory professionals to identify patients with potential warfarin sensitivity. Provides genotype information to assist clinicians in assessing patient risk profiles for anticoagulant therapy. Results aid in clinical decision-making regarding warfarin dosing strategies.

Clinical Evidence

No clinical trials performed. Analytical performance established via method comparison against bi-directional DNA sequencing using 150 genomic DNA samples. Total correct call rate was 98.9% (445/450). Reproducibility study across three sites (540 tests) showed 99.9% correct call rate. Extraction method comparison (216 tests) showed 99.5% correct call rate. Analytical specificity testing confirmed no interference from bilirubin, albumin, triglycerides, or hemolysis.

Technological Characteristics

In vitro diagnostic kit; real-time PCR amplification; Cepheid SmartCycler Dx platform; lyophilized reagents (Taq polymerase, dNTPs, MgCl2, primers, probes); dually-labeled fluorescent probes (5'-reporter/3'-quencher); EDTA-anticoagulated whole blood input; manual Ct-based genotype interpretation.

Indications for Use

Indicated for patients requiring warfarin therapy to identify individuals at increased risk for warfarin sensitivity by detecting CYP2C9 *2, *3 and VKORC1 1173 C>T alleles in EDTA-anticoagulated whole blood.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Paragon Dx™ c/o Ms. Deborah Kloos Director, Quality Systems 133 Southcenter Ct., Suite 200 Morrisville, NC 27560

APR 2 8 2008

Re: k071867

Trade/Device Name: Rapid Genotyping Assay -- CYP2C9 & VKORC1 Regulation Number: 21 CFR 862.3360 Regulation Name: Drug metabolizing enzyme genotyping system Regulatory Class: Class II Product Code: ODW, ODV Dated: March 26, 2008 Received: March 27, 2008

Dear Ms. Kloos:

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).

{1}------------------------------------------------

Page 2 --

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.

Yean 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

{2}------------------------------------------------

## 4.0 Indications for Use

510(k) Number: k071867

Device Name: Rapid Genotyping Assay - CYP2C9 & VKORC1

## Indications for Use:

The Rapid Genotyping Assay - CYP2C9 & VKORC1 is intended to be used as an in vitro diagnostic test kit that detects the presence of CYP2C9 *2 and *3 and VKORC1 1173 C>T alleles. This test is for use with EDTA-anticoagulated whole blood samples. Information about the CYP2C9 and VKORC1 genotypes may be used as an aid in the identification of patients with greater risk for warfarin sensitivity.

Prescription Use V - -

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1__

Confidential ParagonDx, LLC

k071867 Section 4.0 - Indications for Use

4/23/2008