(31 days)
Not Found
Not Found
No
The description details a standard in vitro diagnostic kit for genetic testing, focusing on DNA isolation and detection using a LightCycler. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is an in vitro diagnostic test intended as an aid to diagnosis, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the test "is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia." This explicitly indicates its use in diagnosis.
No
The device is an in vitro diagnostic test kit, which includes reagents and is used with a specific hardware platform (LightCycler). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test" and is intended to be used "as an aid to diagnosis in the evaluation of patients with suspected thrombophilia." This clearly indicates its use for diagnostic purposes outside of the living body.
- Device Description: The description reiterates that it is an "in vitro diagnostic test."
- Sample Type: It uses "DNA isolated from human whole peripheral blood," which is a biological sample taken from the body and analyzed in vitro.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Factor II (Prothrombin) G20210A Kit allows 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 performed on the LightCycler Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor II DNA recovered from clinical samples and fluorigenic target-specific hybridization 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 preparation must be performed according to the workflow procedure described in the package insert.
The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
NPR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human whole peripheral blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence: The Factor II (Prothrombin) G20210A Kit gives equivalent results to a DNA sequencing method. A total of 572 samples were tested and 99.5% agreement was observed between the methods.
Performance Characteristics:
Precision: 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):
§ 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.)
0
| | DEC 1 8 2003
510(k) Summary |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Road
Indianapolis, IN 46250
(317) 521 - 2386 |
| | Contact Person: Robert A. Gregg
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
Description | 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. |
| Intended use | The Factor II (Prothrombin) G20210A Kit allows 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 performed on the LightCycler Instrument utilizing
polymerase chain reaction (PCR) for the amplification of Factor II DNA
recovered from clinical samples and fluorigenic target-specific hybridization
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
preparation must be performed according to the workflow procedure
described in the package insert. |
:
1
| Indications for
Use | The Factor II (Prothrombin) G20210A Kit is an in vitro diagnostic test 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. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
equivalence | The Factor II (Prothrombin) G20210A Kit gives equivalent results to a DNA
sequencing method. A total of 572 samples were tested and 99.5% agreement
was observed between the methods. |
| Performance
characteristics | 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-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) | 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).
3
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 (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
4
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