(139 days)
Not Found
No
The description focuses on automated PCR and DNA detection, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is an in vitro diagnostic genotyping test used to detect genetic mutations that aid in the diagnosis of suspected thrombophilia. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "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." This directly indicates its role in diagnosis.
No
The device description clearly states that the test is performed on the Cepheid GeneXpert® Instrument Systems, which are hardware platforms. The device also includes single-use disposable cartridges containing reagents. While software is mentioned as part of the system, the core functionality and components are hardware-based.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states it is a "qualitative in vitro diagnostic genotyping test". It also describes its use for detecting specific genetic mutations from blood samples to aid in the diagnosis of suspected thrombophilia. This clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details how the device processes blood samples (taken from the body) using reagents and a system to perform genetic analysis (PCR) to detect specific DNA sequences. This process is performed in vitro (outside the body).
- Predicate Device: The mention of a predicate device (K082118; Cepheid Xpert HemosIL Factor II & Factor V) which is also an IVD, further supports the classification of this device as an IVD.
The information provided strongly indicates that this device is designed and intended for in vitro diagnostic use.
N/A
Intended Use / 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.
Product codes
NPR, NPQ, OOI
Device Description
The Cepheid Xpert® FII & FV is a rapid, automated DNA test for detecting FII and FV normal and mutant alleles directly from sodium citrate or EDTA anticoagulated whole blood specimens. Blood specimens are drawn into either sodium citrate or EDTA anticoagulant tubes. Following brief mixing of the sample, 50 uL of the blood sample is transferred to the bottom wall of the Sample opening of the Xpert FII & FV test cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert® Instrument system instrument platform (comprised of the GeneXpert Dx Systems and GeneXpert Infinity Systems), which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of DNA. In the GeneXpert Instrument Systems platform, sample preparation, amplification, and real-time detection are all fully-automated and completely integrated.
The GeneXpert Instrument Systems have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection.
The Xpert FII & FV test includes reagents for the detection of Factor II and Factor V normal and mutant alleles. The primers and probes in the Xpert FII & FV test determine the genotype of the Factor II gene (at position 20210) and the Factor V gene (at position 1691). The test includes a Sample Processing Control to confirm adequate processing of the target bacteria and to monitor the presence of inhibitor(s) in the PCR assay. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability.
The test is performed on the Cepheid GeneXpert Instrument Systems, which automate and integrate sample purification, nucleic acid amplification of the target sequences in simple or complex samples using real-time PCR. The systems consist of an instrument, personal computer, and preloaded software for running the tests and viewing the results. The GeneXpert Instrument Systems require the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, crosscontamination between samples is minimized. In this platform, additional sample preparation, amplification, and real-time detection are all fully- automated and completely integrated. The Xpert FII & FV test performed on the GeneXpert Instrument Systems provides results in approximately 30 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory Users: Trained users
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The performance of the Xpert FII & FV test when used with the GeneXpert Infinity Systems was assessed through verification studies, including a Cartridge Hold Time study and Functional Testing study. The assessment of the results from these studies determined that the performance claims of the Xpert FII & FV test were not impacted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7280 Factor V Leiden DNA mutation detection systems.
(a)
Identification. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.(b)
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.)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2023
Cepheid Bobbi Ferrell Principal Regulatory Affairs Specialist 904 Caribbean Drive Sunnyvale, CA 94089
Re: K223046
Trade/Device Name: Xpert FII & FV Regulation Number: 21 CFR 864.7280 Regulation Name: Factor V Leiden DNA Mutation Detection Systems Regulatory Class: Class II Product Code: NPR, NPQ, OOI Dated: September 29, 2022 Received: September 29, 2022
Dear Bobbi Ferrell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the text "Min Wu -" in a simple, sans-serif font. The text is arranged horizontally, with a clear separation between the words. The background is plain white, which makes the text stand out. The text is written in black.
Min Wu, Ph.D. Branch Chief for Hematology Branch Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223046
Device Name Xpert® FII & FV
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image contains the Cepheid company logo, which features a stylized blue wing-like design above the company name in a simple sans-serif font. Below the company name, the text "Xpert® FII & FV" is displayed, indicating a specific product or service offered by Cepheid. The text is in a smaller font size compared to the company name, and the "Xpert" is followed by a registered trademark symbol.
5. 510(k) Summary
As required by 21 CFR Section 807.92(c). The purpose of this submission is to submit documentation to support the addition of the GeneXpert Infinity systems for the use with Xpert FII & FV (GXFIIFV-10).
| Submitted by: | Cepheid
904 Caribbean Drive
Sunnyvale, CA 90489
Phone number: (408) 400-8230
Fax number: (408) 541-6439 |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bobbi L. Ferrell, MSRA |
| Date of Preparation: | September 27, 2022 |
| Proprietary/Trade name: | Xpert® FII & FV |
| Common name: | Xpert® Factor II & Factor V |
| Type of Test: | Nucleic Acid Amplification Test, DNA, Factor II
Prothrombin G20210A and Factor V G1691A (Leiden)
qualitative, genotyping |
| Regulation number,
Classification name,
Product code: | 21 CFR 864.7280, Factor II Prothrombin and Factor V
Leiden DNA Mutation Detection Systems, NPQ, NPR
21 CFR 862.2570, Real Time Nucleic Acid Amplification System, OOI; |
| Classification Advisory
Panel | Pathology |
| Prescription Use | Yes |
| Predicate Device Test: | Cepheid Xpert HemosIL Factor II & Factor V (K082118) |
5.1 Device Description
The Cepheid Xpert® FII & FV is a rapid, automated DNA test for detecting FII and FV normal and mutant alleles directly from sodium citrate or EDTA anticoagulated whole blood specimens. Blood specimens are drawn into either sodium citrate or EDTA anticoagulant tubes. Following brief mixing of the sample, 50 uL of the blood sample is transferred to the bottom wall of the Sample opening of the Xpert FII & FV test cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert® Instrument system instrument platform (comprised of the GeneXpert Dx Systems and GeneXpert Infinity Systems), which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of DNA. In the GeneXpert Instrument Systems platform, sample preparation, amplification, and real-time detection are all fully-automated and completely integrated.
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Image /page/4/Picture/1 description: The image contains the Cepheid company logo, which features a stylized blue wing-like design above the company name in black. Below the company name, the text "Xpert® FII & FV" is displayed, indicating a specific product or service offered by Cepheid. The text is also in black and appears to be a part of the product branding.
The GeneXpert Instrument Systems have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real- time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection.
The Xpert FII & FV test includes reagents for the detection of Factor II and Factor V normal and mutant alleles. The primers and probes in the Xpert FII & FV test determine the genotype of the Factor II gene (at position 20210) and the Factor V gene (at position 1691). The test includes a Sample Processing Control to confirm adequate processing of the target bacteria and to monitor the presence of inhibitor(s) in the PCR assay. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability.
The test is performed on the Cepheid GeneXpert Instrument Systems, which automate and integrate sample purification, nucleic acid amplification of the target sequences in simple or complex samples using real-time PCR. The systems consist of an instrument, personal computer, and preloaded software for running the tests and viewing the results. The GeneXpert Instrument Systems require the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, crosscontamination between samples is minimized. In this platform, additional sample preparation, amplification, and real-time detection are all fully- automated and completely integrated. The Xpert FII & FV test performed on the GeneXpert Instrument Systems provides results in approximately 30 minutes.
5.2 Intended 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.
5.3 Technical Characteristics
The Xpert FII & FV test has the same technological characteristics as the predicate device.
5.4 Substantial Equivalence
The purpose of this Special 510(k) submission is for a modification to an existing device (Xpert® FII & FV) to incorporate its intended use on an additional instrument, the GeneXpert Infinity Systems. Table 5-1 shows the similarities and differences between the Xpert FII & FV test and predicate device. The differences between Xpert FII & FV test and the predicate device do not raise different questions of safety and effectiveness.
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Image /page/5/Picture/0 description: The image contains the Cepheid company logo, which features a stylized blue wing-like design above the company name in black. Below the company name, the text "Xpert® FII & FV" is displayed, indicating a specific product or service offered by Cepheid. The logo is clean and professional, suggesting a focus on technology and innovation in the medical or diagnostic field.
| Table 5-1: Comparison of Similarities and Differences | ||
|---|---|---|
| of Modified and Predicate Xpert FII & FV |
| Similarities | ||
|---|---|---|
| Item | Modified Device | Predicate Device |
| Xpert Factor II & Factor V | Xpert (HemosIL) Factor II & Factor V | |
| (K082118) | ||
| Indications for Use | Same | Aid in the identification of individuals |
| suspected with thrombophilia | ||
| Sample Preparation | Same | Self-contained and automated after mixed |
| specimen is added to cartridge. | ||
| Laboratory Users | Same | Trained users |
| Specimen Type | Same | Sodium citrate or EDTA anticoagulated whole |
| blood | ||
| Test Technology | Same | Fully automated nucleic acid amplification |
| (DNA); real-time PCR | ||
| Test Cartridge | ||
| Technology | Same | Disposable single-use, multi-chambered |
| fluidic cartridge | ||
| Internal Controls | Same | Sample processing control (SPC) and probe |
| check control (PCC). | ||
| DNA Target Sequence | Same | Sequence specific to for Factor II (G20210A) |
| and Factor V Leiden (G1691A) mutations | ||
| Time to Results | Same | Approximately 30 minutes to result |
| Assay Definition File | ||
| Results Algorithm | Same | Rules-based algorithms incorporating delta Ct |
| values between targets within a valid Ct range | ||
| and algorithms based on the Ct value for the | ||
| targets falling within a valid Ct range. | ||
| Differences | ||
| Modified Device | Predicate Device | |
| Item | Xpert FII & FV | Xpert (HemosIL) Factor II & Factor V |
| K082118 | ||
| Intended Use | ||
| (Difference bolded) | 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. | The Xpert® Factor II & Factor V 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® Dx 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. | ||
| Instrument System | Cepheid GeneXpert Dx Systems and | |
| GeneXpert Infinity-48s and Infinity- | ||
| 80 Systems | Cepheid GeneXpert Dx Systems | |
| Software | GeneXpert Dx software version | |
| 4.0 and higher, GeneXpert Infinity-48s | ||
| and Infinity-80 Xpertise software | ||
| version 6.6 and higher | GeneXpert Dx software version | |
| 2.1 or higher |
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Image /page/6/Picture/0 description: The image contains the Cepheid company logo, which features a stylized blue wing-like design above the company name in black. Below the company name, the text "Xpert® FII & FV" is displayed, indicating a specific product or service offered by Cepheid. The "Xpert" is followed by a registered trademark symbol.
5.5 Summary of Performance Data
The performance of the Xpert FII & FV test when used with the GeneXpert Infinity Systems was assessed through verification studies, including a Cartridge Hold Time study and Functional Testing study. The assessment of the results from these studies determined that the performance claims of the Xpert FII & FV test were not impacted.
5.6 Conclusion
The results of the verification studies demonstrate that the Xpert FII & FV test as performed on the GeneXpert Infinity Systems is substantially equivalent to the original design of the Xpert (HemosIL) Factor II & Factor V (K082118, the predicate device).