Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
The Factor II G20210A mutation genomic DNA PCR test is a hematology in vitro diagnostic device used to detect the prothrombin G20210A mutation in genomic DNA, aiding in the diagnosis of patients with suspected thrombophilia and elevated clotting risk. It is classified as FDA Class 2 under regulation 864.7280 in the Hematology specialty (reviewed by Pathology panel), requiring 510(k) premarket notification. Product code NPR is not eligible for third-party review.
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Basic Information
- Product Code
- NPR
- Device Class
- FDA class 2
- Regulation Number
- 864.7280
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250218 | Xpert® FII & FV | Feb 21, 2025 | Substantially Equivalent | Cepheid |
| K223046 | Xpert® FII & FV | Feb 15, 2023 | Substantially Equivalent | Cepheid® |
| K172913 | cobas Factor II and Factor V Test | Jan 12, 2018 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K100943 | INVADER FACTOR II | Jun 02, 2011 | Substantially Equivalent | Hologic, Inc. |
| K033612 | FACTOR II (PROTHROMBIN) G20210A KIT | Dec 18, 2003 | Substantially Equivalent | Roche Diagnostics Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.