Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7280](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7280) → NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

# NPR · Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

_Hematology · 21 CFR 864.7280 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR

## Overview

- **Product Code:** NPR
- **Device Name:** Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- **Regulation:** [21 CFR 864.7280](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7280)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

Factor V Leiden mutation detection system is a device that allows the detection and genotyping of a single point mutation of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The system consists of different reagents and instruments which includes polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection system is an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

## Classification Rationale

FDA concludes that this device, and substantially equivalent devices of this generic type, should be classified into class II. FDA has determined that the Factor V Leiden Kit can be classified in class II with the establishment of special controls, which provide reasonable assurance of the safety and effectiveness of the device type.

## Special Controls

*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.)

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250218](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR/K250218.md) | Xpert® FII & FV | Cepheid | Feb 21, 2025 | SESE |
| [K223046](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR/K223046.md) | Xpert® FII & FV | Cepheid® | Feb 15, 2023 | SESE |
| [K172913](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR/K172913.md) | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | Jan 12, 2018 | SESE |
| [K100943](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR/K100943.md) | INVADER FACTOR II | Hologic, Inc. | Jun 2, 2011 | SESE |
| [K033612](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR/K033612.md) | FACTOR II (PROTHROMBIN) G20210A KIT | Roche Diagnostics Corp. | Dec 18, 2003 | SESE |

## Top Applicants

- Cepheid — 1 clearance
- Cepheid® — 1 clearance
- Hologic, Inc. — 1 clearance
- Roche Diagnostics Corp. — 1 clearance
- Roche Molecular Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/NPR)

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