Xpert® FII & FV

K250218 · Cepheid · NPR · Feb 21, 2025 · Hematology

Device Facts

• Record ID: K250218
• Device Name: Xpert® FII & FV
• Applicant: Cepheid
• Product Code: NPR · Hematology
• Decision Date: Feb 21, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7280
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Xpert® FII & FV test is a qualitative in vitro diagnostic genotyping test for the detection of Factor II and Factor V alleles from sodium citrate or EDTA anticoagulated whole blood. The test is performed on the GeneXpert® Instrument Systems. This test is intended to provide results for Factor II (G20210A) and Factor V Leiden (G1691A) mutations as an aid in the diagnosis in individuals with suspected thrombophilia.

Device Story

Xpert FII & FV is an in vitro diagnostic test for detecting Factor II and Factor V Leiden DNA mutations. Device utilizes cartridge-based reagents for automated nucleic acid extraction and real-time PCR amplification/detection. Operated by laboratory personnel in clinical settings. Modification involves updating labeling to remove statement regarding lack of pediatric evaluation, as pediatric subjects were previously validated in K082118. No changes to cartridge components, reagents, or fundamental scientific technology. Output provides qualitative detection of mutations to assist clinicians in assessing thrombophilia risk.

Clinical Evidence

No new clinical data provided. Removal of pediatric limitation statement supported by clinical validation data from original clearance (K082118).

Technological Characteristics

Fully automated real-time PCR; disposable multi-chambered fluidic cartridge; Scorpion probes; internal controls (Sample Processing Control, Probe Check Control). Operates on GeneXpert Instrument Systems (GeneXpert Dx, Infinity, Touchscreen) featuring I-CORE thermocycler, syringe drive, and ultrasonic lysis. Software-based automated result interpretation.

Indications for Use

Indicated for the detection of Factor II (prothrombin) and Factor V Leiden DNA mutations in human whole blood specimens to aid in the diagnosis of thrombophilia.

Regulatory Classification

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.

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.)

Predicate Devices

• Xpert FII & FV (K223046)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K250218

B Applicant

Cepheid

C Proprietary and Established Names

Xpert® FII & FV

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NPR | Class II | 21 CFR 864.7280 - Factor V Leiden DNA Mutation Detection Systems | PA - Pathology |
| NPQ | Class II | 21 CFR 864.7280 - Factor V Leiden DNA mutation detection systems | PA - Pathology |
| OOI | Class II | 21 CFR 862.2570 – Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (K223046).
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device **has not changed**.

This change was to remove the following statement from the labeling, “The performance of the Xpert Factor II & Factor V test has not been evaluated with samples pediatric patients”, because pediatric subjects were evaluated in the method comparison study that was submitted for the device in premarket notification K082118. No changes have been made to the Xpert FII & FV cartridge components, reagents, and design.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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