(31 days)
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 test is intended to be used on the LightCycler using SW 3.5. The sample preparation must be performed according to the workflow procedure described in the package insert. The Factor II (Prothrombin) G20210A Kit is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation, from DNA isolated from human whole peripheral blood.
Acceptance Criteria and Device Performance Study for K033612
This analysis describes the acceptance criteria and the study used to demonstrate that the Factor II (Prothrombin) G20210A Kit meets these criteria, as detailed in the provided 510(k) summary (K033612).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | High agreement with a DNA sequencing method. | 99.5% agreement with a DNA sequencing method. |
| Precision | Consistent and reproducible results. | Within-run: 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 Sensitivity (LDL) | Ability to detect low concentrations of allele copies. | < 50 allele copies per reaction |
| Reagent Stability | Stable performance over time and under specified conditions. | 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 | Minimal interference from common substances in samples. | High concentrations of heparin might interfere. No interference from EDTA or citrate anticoagulants. |
| Precautions and Warnings | Identification of known limitations or potential false results. | One rare mutation (A20218G) will lead to false-positive result after performing the melting curve analysis. |
Note: The 510(k) summary does not explicitly state numerical acceptance criteria for each test; however, the "Performance Characteristics" section implicitly sets the acceptance criteria by reporting the observed performance, which is deemed sufficient for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 572 samples were tested for the substantial equivalence study.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the samples were collected retrospectively or prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set. The ground truth was established by a "DNA sequencing method."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is provided in the document. This type of study is more common for imaging devices where human interpretation is a critical part of the diagnostic process. This device is an in vitro diagnostic test for genetic mutation detection, which typically involves automated or semi-automated analysis rather than human reader interpretation in the context of an MRMC study.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Substantial equivalence" section directly compares the device's performance to a DNA sequencing method (the ground truth), reporting 99.5% agreement. This demonstrates the algorithm's (or kit's) performance without explicit human intervention in the interpretation of the Factor II G20210A Kit results.
7. Type of Ground Truth Used
The type of ground truth used for the substantial equivalence study was DNA sequencing method. This is considered a gold standard for genetic mutation detection.
8. Sample Size for the Training Set
The document does not specify the sample size for a training set. This is common for IVD kits where the primary validation is often based on the performance of the prepared reagents and assay protocol against a gold standard, rather than training a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned for a machine learning algorithm, there is no information on how its ground truth would have been established. For the overall validation of the kit, the DNA sequencing method served as the established ground truth.
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| DEC 1 8 2003510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46250(317) 521 - 2386 |
| Contact Person: Robert A. GreggDate 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 | |
| DeviceDescription | The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test for thedetection and genotyping of the Factor II (Prothrombin) G20210A mutation,from DNA isolated from human whole peripheral blood. |
| Intended use | The Factor II (Prothrombin) G20210A Kit allows the detection andgenotyping of a single point mutation (G to A at position 20210) of thehuman Factor II gene, from DNA isolated from human whole peripheralblood. The test is performed on the LightCycler Instrument utilizingpolymerase chain reaction (PCR) for the amplification of Factor II DNArecovered from clinical samples and fluorigenic target-specific hybridizationfor 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 samplepreparation must be performed according to the workflow proceduredescribed in the package insert. |
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| Indications forUse | The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test forthe detection and genotyping of the Factor II (Prothrombin) G20210Amutation as an aid to diagnosis in the evaluation of patients with suspectedthrombophilia. |
|---|---|
| Substantialequivalence | The Factor II (Prothrombin) G20210A Kit gives equivalent results to a DNAsequencing method. A total of 572 samples were tested and 99.5% agreementwas observed between the methods. |
| Performancecharacteristics | The following table lists performance characteristics of the Factor II(Prothrombin) G20210A Kit |
|---|---|
| -------------------------------- | ----------------------------------------------------------------------------------------------------- |
Table 2 - Performance Characteristics
| Feature | Factor II (Prothrombin) G20210A Kit performance |
|---|---|
| Precision | Within-runTm1: 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% |
| Analyticalsensitivity (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 andWarnings | • One rare mutation will lead to false-positive result after performing themelting 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
§ 864.7280 Factor V Leiden DNA mutation detection systems.
(a)
Identification. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.(b)
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.)