FACTOR II (PROTHROMBIN) G20210A KIT

K033612 · Roche Diagnostics Corp. · NPR · Dec 18, 2003 · Hematology

Device Facts

• Record ID: K033612
• Device Name: FACTOR II (PROTHROMBIN) G20210A KIT
• Applicant: Roche Diagnostics Corp.
• Product Code: NPR · Hematology
• Decision Date: Dec 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7280
• Device Class: Class 2

Intended Use

The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of a single point mutations (G to A at position 20210) of the human Factor II gene, from DNA isolated from human whole peripheral blood. The Factor II (Prothrombin) G20210A Kit is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia

Device Story

In vitro diagnostic test for detection/genotyping of Factor II (Prothrombin) G20210A mutation; utilizes DNA isolated from human whole peripheral blood. Operates on LightCycler Instrument using PCR for DNA amplification and fluorigenic target-specific hybridization for genotyping. Used in clinical laboratory settings. Healthcare providers use output to aid diagnosis of patients with suspected thrombophilia. Benefits include identification of genetic risk factor for thrombosis.

Clinical Evidence

Clinical validation performed by comparing kit results against DNA sequencing method. Study included 572 samples; observed 99.5% agreement between methods.

Technological Characteristics

In vitro diagnostic kit; utilizes PCR amplification and fluorigenic target-specific hybridization. Designed for use on LightCycler Instrument with SW 3.5. Analytical sensitivity < 50 allele copies per reaction. Reagents stable at -15 to -25°C.

Indications for Use

Indicated for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Regulatory Classification

Identification

In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems.” (See § 864.1(d) for the availability of this guidance document.)

Submission Summary (Full Text)

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K033612

| | DEC 1 8 2003<br>510(k) Summary |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
| Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 521 - 2386 |
| | Contact Person: Robert A. Gregg<br>Date Prepared: November 14, 2003 |
| Device Name | Proprietary name: Factor II (Prothrombin) G20210A Kit |
| | Common name: Factor II (Prothrombin) G20210A Kit |
| | Classification name: Factor deficiency test |
| Device<br>Description | The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the<br>detection and genotyping of the Factor II (Prothrombin) G20210A mutation,<br>from DNA isolated from human whole peripheral blood. |
| Intended use | The Factor II (Prothrombin) G20210A Kit allows the detection and<br>genotyping of a single point mutation (G to A at position 20210) of the<br>human Factor II gene, from DNA isolated from human whole peripheral<br>blood. The test is performed on the LightCycler Instrument utilizing<br>polymerase chain reaction (PCR) for the amplification of Factor II DNA<br>recovered from clinical samples and fluorigenic target-specific hybridization<br>for the detection and genotyping of the amplified Factor II DNA. |
| | The test is intended to be used on the LightCycler using SW 3.5. The sample<br>preparation must be performed according to the workflow procedure<br>described in the package insert. |

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| Indications for<br>Use | The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for<br>the detection and genotyping of the Factor II (Prothrombin) G20210A<br>mutation as an aid to diagnosis in the evaluation of patients with suspected<br>thrombophilia. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>equivalence | The Factor II (Prothrombin) G20210A Kit gives equivalent results to a DNA<br>sequencing method. A total of 572 samples were tested and 99.5% agreement<br>was observed between the methods. |

| Performance<br>characteristics | The following table lists performance characteristics of the Factor II<br>(Prothrombin) G20210A Kit |
|--------------------------------|-----------------------------------------------------------------------------------------------------|
|--------------------------------|-----------------------------------------------------------------------------------------------------|

Table 2 - Performance Characteristics

| Feature | Factor II (Prothrombin) G20210A Kit performance |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within-run<br>Tm1: 0.14 – 0.26 % CV Tm2: 0.14 – 0.24 % CV ΔTm: 0.58- 0.90% CV Total Tm1: 0.19 – 0.33 % CV Tm2: 0.22 – 0.44 % CV ΔTm: 1.23- 1.53 % CV Overall median: 0.36% |
| Analytical<br>sensitivity (LDL) | < 50 allele copies per reaction |
| Reagent Stability | Store up to stated expiration date at -15 to -25°C. Protect from light Freeze immediately after use Kit reagents may be frozen and thawed up to five times |
| Interferences | High concentrations of heparin might interfere with the polymerase chain reaction. No interference from EDTA or citrate anticoagulants. |
| Precautions and<br>Warnings | • One rare mutation will lead to false-positive result after performing the<br>melting curve analysis (i.e., the mutation A20218G) |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 8 2003

Robert Gregg, Ph.D. Director, Regulatory Submissions Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250

Re: k033612

> Trade/Device Name: Factor II (prothrombin) G20210A Kit Regulation Number: 21 CFR 864.7280 Regulation Name: Factor V Leiden DNA mutation detection systems Regulatory Class: Class II Product Code: NPR Dated: November 14, 2003 Received: November 17, 2003

Dear Dr. Gregg:

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. Ilsting 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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## K033612 510(k) Number (if known): NAA

Device Name:

## Factor II (Prothrombin) G20210A Kit

Indications For Use:

The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene, from DNA isolated from human whole peripheral blood.

The Factor II (Prothrombin) G20210A Kit is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

The test is intended to be used on the LightCycler Instrument. The sample preparation must be performed according to a workflow procedure described in the package insert.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Tas for
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033612