Xpert® FII & FV

K223046 · Cepheid® · NPR · Feb 15, 2023 · Hematology

Device Facts

• Record ID: K223046
• Device Name: Xpert® FII & FV
• Applicant: Cepheid®
• Product Code: NPR · Hematology
• Decision Date: Feb 15, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7280
• Device Class: Class 2

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 Cepheid 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 a rapid, automated, qualitative in vitro diagnostic genotyping test. Input: 50 uL sodium citrate or EDTA anticoagulated whole blood. Process: Sample transferred to single-use disposable cartridge; GeneXpert Instrument System (Dx or Infinity) performs fully-automated, integrated sample preparation, nucleic acid amplification, and real-time PCR. System uses syringe drive for fluid movement, ultrasonic horn for cell lysis, and I-CORE thermocycler. Output: Genotype results for Factor II (G20210A) and Factor V (G1691A) mutations. Used in clinical laboratory settings by trained users. Results provided in approximately 30 minutes. Output aids clinicians in diagnosing thrombophilia. Benefits: Rapid, self-contained, automated testing minimizes cross-contamination and provides timely diagnostic information.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design control activities, risk analysis, and verification/validation testing demonstrating that the modification to include the GeneXpert Infinity Systems does not alter the fundamental scientific technology or performance of the assay.

Technological Characteristics

Real-time PCR-based molecular diagnostic assay. Components: single-use cartridge containing reagents for DNA extraction and amplification. Connectivity: GeneXpert Instrument Systems (networked/standalone). Software: Assay Definition File (ADF) containing PCR parameters, Ct cutoffs, and result interpretation algorithms. Sterilization: N/A (reagent-based).

Indications for Use

Indicated for patients with suspected thrombophilia to detect Factor II G20210A and Factor V Leiden G1691A mutations in human genomic DNA from EDTA or sodium citrate whole blood.

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 (K082118)

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

K223046

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 (K082118).
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,

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

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 for modification to an existing device (Xpert FII & FV) to incorporate its intended use on an additional instrument, the GeneXpert Infinity Systems. The modified design of Xpert FII & FV test has the same intended use and the same technological characteristics as the original design (K082118, the predicate device). The difference between the modified design of Xpert FII & FV test and the original design is the inclusion of the GeneXpert Infinity Systems. No changes have been made to the Xpert FII & FV cartridge components, reagents, and design. Assay parameters as defined in the Assay Definition File (ADF) which includes, PCR parameters, assay Ct cutoff values, algorithm for determining assay results and reportable results also remain unchanged.

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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