# K033612: Factor II (Prothrombin) G20210A Kit

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 18, 2003 after 31 days
- Product code: NPR (Test, Factor Ii G20210a Mutations, Genomic Dna Pcr)
- Device class: 2
- Regulation: 21 CFR 864.7280
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test (2007), 3 descendants of its own
- K082118: Xpert Hemosil Factor II & Factor V Assay (2009), 2 descendants of its own
- K223046: Xpert® FII & FV (2023), 1 descendant of its own
- K250218: Xpert® FII & FV (2025), 0 descendants of its own
- K172913: cobas Factor II and Factor V Test (2018), 0 descendants of its own

## Recalls of this device
- Oct 26, 2010 · Not classified · Z-1652-2011: If the bar code is printed from the Batch Results Screen, a wrong batch ID may be printed, while the correct batch ID is still assigned to the batch in the data repository of the MPLC 2.0 software. Th
- Mar 12, 2009 · Not classified · Z1006-2010: Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spa

## 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.

Source page: https://510kreport.com/device/K033612
Methodology: https://510kreport.com/methodology