Product code NPR— Hematology

Xpert® FII & FV

Classification name: Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Total cleared: 5
First cleared: 2003-12-18
Most recent: 2025-02-21

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code NPR under 21 CFR 864.7280, via openFDA

Market context for product code NPR

FDA has cleared 5 devices under product code NPR between 2003 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20251 clearance
20231 clearance
20181 clearance
20111 clearance
20031 clearance

Top applicants under product code NPR

Cepheid2 clearances
Roche Molecular Systems, Inc.1 clearance
Roche Diagnostics Corp.1 clearance
Hologic, Inc.1 clearance

Recent clearances under product code NPR

K250218 — Xpert® FII & FVCepheid·2025-02-21
K223046 — Xpert® FII & FVCepheid®·2023-02-15
K172913 — cobas Factor II and Factor V TestRoche Molecular Systems, Inc.·2018-01-12
K100943 — INVADER FACTOR IIHologic, Inc.·2011-06-02
K033612 — FACTOR II (PROTHROMBIN) G20210A KITRoche Diagnostics Corp.·2003-12-18

Data sourced from openFDA. This site is unofficial and independent of the FDA.