(391 days)
Not Found
No
The device description focuses on automated PCR technology and standard controls, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic test designed to detect Group B Streptococcus DNA, which aids in identifying GBS colonization. It does not provide any direct therapeutic benefit or treatment.
Yes
The "Intended Use / Indications for Use" states that the test is "intended to aid in the detection of GBS colonization." The "Device Description" also specifies that "The Xpert® Xpress GBS test is an automated in vitro diagnostic test for the qualitative detection of Group B Streptococcus (GBS) DNA". These phrases clearly indicate that the device is used to diagnose (detect) a medical condition (GBS colonization).
No
The device description clearly states that the Xpert Xpress GBS test is performed on the Cepheid GeneXpert Instrument Systems, which include hardware components like the instrument, computer, syringe drive, ultrasonic horn, and thermocycler, in addition to software. It also utilizes single-use disposable cartridges. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Xpert® Xpress GBS test is an "automated, real-time PCR test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients". This describes a test performed on biological samples taken from the human body to provide information about a patient's health status (detection of GBS colonization).
- Device Description: The "Device Description" section further clarifies that it is an "automated in vitro diagnostic test". It describes the components and process of the test, which involves analyzing a biological specimen (vaginal/rectal swab) outside of the body using laboratory equipment and reagents.
- Performance Studies: The inclusion of performance studies evaluating the test's sensitivity, specificity, PPV, and NPV against a comparator method (enriched culture) is typical for IVD devices seeking regulatory clearance. These metrics demonstrate the device's ability to accurately detect the target analyte in patient samples.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. The Xpert® Xpress GBS test fits this definition perfectly.
N/A
Intended Use / Indications for Use
The Xpert® Xpress GBS test, performed on the GeneXpert® Instrument Systems, is an automated, real-time PCR test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients for intrapartum testing at term (e.g., >37 weeks) who have unknown or unavailable antepartum GBS screening test results and no additional risk factors that would warrant empiric antibiotic prophylaxis. The Xpert Xpress GBS test performed during intrapartum is intended to aid in the detection of GBS colonization in patients presenting in labor who may be candidates for antibiotic prophylaxis.
The Xpert Xpress GBS test does not provide antimicrobial susceptibility test results. Culture is necessary to obtain isolates to perform susceptibility testing as recommended for penicillin-allergic patients.
This test is conducted using direct specimen without enrichment is recommended to enhance detection of GBS colonization). In contrast to a positive test result, which can indicate colonization, a presumptive negative result cannot exclude the possibility of GBS colonization. A false negative test result at intrapartum carries a potential harm to the infant if it is used in making decisions regarding empiric antibiotic prophylaxis. Providers must use caution and default to known patient risk factors and clinical guidance regarding a role for intrapartum prophylaxis.
Product codes (comma separated list FDA assigned to the subject device)
NJR, OOI
Device Description
The Xpert® Xpress GBS test is an automated in vitro diagnostic test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients at intrapartum.
The Xpert Xpress GBS test is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx. GeneXpert Infinity-48s and GeneXpert Infinity-80 systems), which consist of an instrument, computer and preloaded software for running tests and viewing the results. The GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and real-time detection. Depending on the instrument, the GeneXpert Instrument Systems can have from 1 and up to 80 randomly accessible modules, 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 as well as detection. The systems require the use of single-use disposable cartridges that hold the PCR reagents and host sample purification, nucleic acid amplification, and detection of the target sequences. Because the cartridges are self- contained, cross-contamination between cartridges during the testing process is minimized.
The Xpert Xpress GBS test includes reagents for the simultaneous detection of target GBS DNA from vaginal/rectal swab specimens. The primers and probes in the Xpert Xpress GBS test are designed to amplify and detect unique sequence in two conserved chromosomal targets in S. agalactiae: a) a member of the glycosysl transferase gene family, and b) a LysR transcriptional regulator. A Sample Adequacy Control (SAC), Sample Processing Control (SPC) and a Probe Check Control (PCC) are also included in the cartridge utilized by the GeneXpert instrument. The SAC is a non-target sequence naturally present in the specimen. which is amplified along with the assay target. In the Xpert Xpress GBS test, the SAC detects the presence of the human hydroxymethylbilane synthase (HMBS) gene to ensure that the sample is properly collected and contains adequate human cells from the vaginal/rectal flora. The SPC is present to control for adequate processing of the sample and to monitor for the presence of potential inhibitor(s) in the PCR reaction. The SPC also ensures that the PCR reaction conditions (temperature and time) are appropriate for the amplification reaction and that the PCR reagents are functional. The PCC verifies reagent rehydration. PCR tube filling, and confirms that all reaction components are present in the cartridge including monitoring for probe integrity and dye stability.
The Xpert Xpress GBS test is designed for use with vaginal/rectal swab specimens collected from pregnant patients at intrapartum and placed into a collection device. The ancillary specimen collection kit validated for use with the Xpert Xpress GBS test is the Cepheid Collection Device (Catalog 900-0370). The sample collection device allows dual vaginal/rectal swab specimens from patients to be collected and transported to laboratory prior to analysis with the Xpert Xpress GBS test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal/rectal swab specimens
Indicated Patient Age Range
14-17 (0.2%)
18-24 (31.3%)
25-34 (55.6%)
≥35 (12.9%)
Intended User / Care Setting
Not Found
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
Clinical performance characteristics of the Xpert Xpress GBS test were evaluated in a multisite, observational, method comparison study using vaginal/rectal swab specimens collected from pregnant patients. The study was conducted at twelve (12) clinical sites from geographically diverse regions within the United States between July 2020 and November 2021.
Nine hundred and twelve (912) vaginal/rectal swab specimens were enrolled from eligible participants. Of the 912, 13 were excluded from the analysis of performance due to non-determinate Xpert Xpress results upon retest or no culture results. A total of 899 intrapartum vaginal/ rectal specimens were included in the performance analyses.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance
- Analytical Sensitivity (LoD) and Analytical Reactivity (Inclusivity): The analytical limit of detection (LoD) and analytical reactivity (inclusivity) of the Xpert Xpress GBS test were determined for 12 different strains representing 12 known serotypes of GBS. Serial dilutions of each serotype were prepared in a simulated sample matrix. Serotypes Ia, III and V were tested with 24 replicates per dilution level for each of two reagent lots across three days. Serotypes Ib, Ic, II, IV and VI-X were tested in replicates of 24 for each dilution level using one reagent lot across three days. The estimated LoD values were verified by testing 20 replicates of each serotype diluted to the upper limit of the 95% confidence interval.
- Analytical Inclusivity of Cfb Mutants: Evaluated 10 unique, well characterized GBS clinical specimens containing different deletions in or adjacent to the cfb gene. Samples were diluted to 855 CFU/mL and tested in 20 replicates over 3 days. All strains showed 100% positivity.
- Analytical Specificity (Cross-Reactivity/Exclusivity) and Microbial Interference: Evaluated a panel of 129 non-GBS organisms (bacterial, viral, parasite, yeast) commonly found in vaginal/rectal flora or phylogenetically related to GBS, tested in presence and absence of GBS (at 3x LoD). Each pull was tested in 6 replicates. No cross-reactivity or microbial interference was observed.
- Potentially Interfering Substances: Evaluated endogenous and exogenous substances (human amniotic fluid, urine, blood, meconium, mucus, fecal material, various medications, lubricants, etc.). Negative samples in simulated matrix and positive samples (GBS serotype Ia at 3x LoD) were tested in 6 replicates per substance. Substances that caused INVALID results were re-tested at lower concentrations.
- Carryover Contamination: A study was conducted to assess whether the single-use, self-contained Xpert Xpress GBS cartridge prevents specimen and amplicon carryover by testing a negative sample immediately after testing a very high positive sample (1.00E+07 CFU/mL or 7.50E+05 CFU/swab) in the same GeneXpert module. This was repeated 10 times in two different modules. All 20 positive samples were correctly reported as GBS POSITIVE. All 22 negative samples were correctly reported as GBS PRESUMPTIVE NEGATIVE.
- Reproducibility and Precision: A multicenter, blinded study using two panels totaling ten members (negative, low positive (~1 – 1.5xLoD), and moderate positive (~3x LoD)) of GBS (Serotypes Ia, III, IV, Ic) in simulated vaginal/rectal matrix. Testing was performed at three sites (one internal, two external) using GeneXpert Instrument Systems. Each panel member was tested in triplicate each day (one run/day) by two operators on six different days at three different sites using three lots of cartridges.
Clinical Performance
- Study Type: Multi-site, observational, method comparison study.
- Sample Size: 912 enrolled specimens, 899 included in performance analysis (13 excluded due to non-determinate results or no culture data).
- Comparator Method: Enriched bacterial culture with species identification via MALDI-TOF MS.
- Key Results:
- Sensitivity: 93.5% (95% CI: 85.7 – 97.2)
- Specificity: 95.5% (95% CI: 93.9 – 96.7)
- PPV: 66.1% (95% CI: 56.8 – 74.3)
- NPV: 99.4% (95% CI: 98.5 – 99.7)
- Non-Determinate Rate:
- Initial: 6.0% (55/912)
- Final (upon retest): 1.3% (12/912)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity = 93.5% (85.7 – 97.2)
Specificity = 95.5% (93.9 – 96.7)
PPV = 66.1% (56.8 – 74.3)
NPV = 99.4% (98.5 – 99.7)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Xpert® GBS (K060540)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
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September 27, 2023
Cepheid Shilpa Kuttetira Senior Regulatory Affairs Specialist 904 Caribbean Drive Sunnyvale, California 94089
Re: K222638
Trade/Device Name: Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus Spp. Serological Reagents Regulatory Class: Class I Product Code: NJR, OOI Dated: August 31, 2022 Received: September 1, 2022
Dear Shilpa Kuttetira:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (QS) 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 medical devices and radiation-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.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222638
Device Name Xpert® Xpress GBS
Indications for Use (Describe)
The Xpert® Xpress GBS test, performed on the GeneXpert® Instrument Systems, is an automated, real-time PCR test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients for intrapartum testing at term (e.g., >37 weeks) who have unknown or unavailable antepartum GBS screening test results and no additional risk factors that would warrant empiric antibiotic prophylaxis. The Xpert Xpress GBS test performed during intrapartum is intended to aid in the detection of GBS colonization in patients presenting in labor who may be candidates for antibiotic prophylaxis.
The Xpert Xpress GBS test does not provide antimicrobial susceptibility test results. Culture is necessary to obtain isolates to perform susceptibility testing as recommended for penicillin-allergic patients.
This test is conducted using direct specimen without enrichment is recommended to enhance detection of GBS colonization). In contrast to a positive test result, which can indicate colonization, a presumptive negative result cannot exclude the possibility of GBS colonization. A false negative test result at intrapartum carries a potential harm to the infant if it is used in making decisions regarding empiric antibiotic prophylaxis. Providers must use caution and default to known patient risk factors and clinical guidance regarding a role for intrapartum prophylaxis
| 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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Traditional 510(k) Submission
510(k) Summary for Xpert Xpress GBS
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TABLE OF CONTENTS
| 5.
| 510(K) SUMMARY | |
|---|---|
| 5.1. DEVICE DESCRIPTION | |
| 5.2. DEVICE INTENDED USE/INDICATIONS FOR USE | |
| 5.3. SUBSTANTIAL EQUIVALENCE | |
| 5.4. PERFORMANCE STUDIES | |
| 5.4.1. ANALYTICAL PERFORMANCE | |
| 5.4.2. CLINICAL PERFORMANCE | |
| 5.5. CONCLUSION |
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5. 510(k) Summary
As required by 21 CFR Section 807.92(c).
| Submitted by: | Cepheid
904 Caribbean Drive
Sunnyvale, CA 90489
Phone Number: (408) 966-8860 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Shilpa Kuttetira |
| Date of Preparation: | September 18, 2023 |
| Trade name: | Xpert® Xpress GBS |
| Common name: | Xpert Xpress GBS |
| Type of Test: | Qualitative real-time polymerase chain reaction (PCR) and
detection test |
| Regulation number, | 21 CFR 866.3740, Streptococcus spp. serological reagents, |
| Classification name, | NJR; A nucleic acid amplification assay system (including
probes, other reagents, and instrumentation) is an aid in the
identification of Group B streptococci from pre-partum and
intra-partum women to establish colonization status. |
| Product code, | 21 CFR 862.2570, Instrumentation for clinical multiplex test
systems, OOI; The system is a clinical multiplex instrument
intended to measure and sort multiple signals generated my
multiple probes, intercalating dyes, or other ligands in an assay
from a clinical sample. Signals may be generated by
fluorescence or other phenomena and may be measured using
filters on a photodiode or other detector. It may integrate sample
and/or reagent handling, amplification, dedicated instrument
control, data acquisition software, raw data storage mechanisms
and other essential hardware components along with the signal
reader unit. The system is used with specific assays to comprise
an assay test system. |
| Classification
Advisory Panel | Microbiology (83) |
| Prescription Use | Yes |
| Predicate Device | Xpert® GBS (K060540) |
CONFIDENTIAL 510(k) Summary Page 3 of 15
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5.1. Device Description
The Xpert® Xpress GBS test is an automated in vitro diagnostic test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients at intrapartum.
The Xpert Xpress GBS test is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx. GeneXpert Infinity-48s and GeneXpert Infinity-80 systems), which consist of an instrument, computer and preloaded software for running tests and viewing the results. The GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and real-time detection. Depending on the instrument, the GeneXpert Instrument Systems can have from 1 and up to 80 randomly accessible modules, 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 as well as detection. The systems require the use of single-use disposable cartridges that hold the PCR reagents and host sample purification, nucleic acid amplification, and detection of the target sequences. Because the cartridges are self- contained, cross-contamination between cartridges during the testing process is minimized.
The Xpert Xpress GBS test includes reagents for the simultaneous detection of target GBS DNA from vaginal/rectal swab specimens. The primers and probes in the Xpert Xpress GBS test are designed to amplify and detect unique sequence in two conserved chromosomal targets in S. agalactiae: a) a member of the glycosysl transferase gene family, and b) a LysR transcriptional regulator. A Sample Adequacy Control (SAC), Sample Processing Control (SPC) and a Probe Check Control (PCC) are also included in the cartridge utilized by the GeneXpert instrument. The SAC is a non-target sequence naturally present in the specimen. which is amplified along with the assay target. In the Xpert Xpress GBS test, the SAC detects the presence of the human hydroxymethylbilane synthase (HMBS) gene to ensure that the sample is properly collected and contains adequate human cells from the vaginal/rectal flora. The SPC is present to control for adequate processing of the sample and to monitor for the presence of potential inhibitor(s) in the PCR reaction. The SPC also ensures that the PCR reaction conditions (temperature and time) are appropriate for the amplification reaction and that the PCR reagents are functional. The PCC verifies reagent rehydration. PCR tube filling, and confirms that all reaction components are present in the cartridge including monitoring for probe integrity and dye stability.
The Xpert Xpress GBS test is designed for use with vaginal/rectal swab specimens collected from pregnant patients at intrapartum and placed into a collection device. The ancillary specimen collection kit validated for use with the Xpert Xpress GBS test is the Cepheid Collection Device (Catalog 900-0370). The sample collection device allows dual vaginal/rectal swab specimens from patients to be collected and transported to laboratory prior to analysis with the Xpert Xpress GBS test.
7
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5.2. Device Intended Use/Indications for Use
The Xpert® Xpress GBS test, performed on the GeneXpert® Instrument Systems, is an automated, real-time PCR test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients for intrapartum testing at term (e.g., >37 weeks) who have unknown or unavailable antepartum GBS screening test results and no additional risk factors that would warrant empiric antibiotic prophylaxis. The Xpert Xpress GBS test performed during intrapartum is intended to aid in the detection of GBS colonization in patients presenting in labor who may be candidates for antibiotic prophylaxis.
The Xpert Xpress GBS test does not provide antimicrobial susceptibility test results. Culture is necessary to obtain isolates to perform susceptibility testing as recommended for penicillinallergic patients.
This test is conducted using direct specimen without enrichment is recommended to enhance detection of GBS colonization). In contrast to a positive test result, which can indicate colonization, a presumptive negative result cannot exclude the possibility of GBS colonization. A false negative test result at intrapartum carries a potential harm to the infant if it is used in making decisions regarding empiric antibiotic prophylaxis. Providers must use caution and default to known patient risk factors and clinical guidance regarding a role for intrapartum prophylaxis.
5.3. Substantial Equivalence
Table 5-1 shows the similarities and differences between Xpert Xpress GBS and the predicate device, Xpert GBS [K060540].
| Attribute | Investigational Device | Predicate Device – K060540 |
|---|---|---|
| Cepheid | ||
| Xpert® Xpress GBS | Cepheid | |
| Xpert® GBS | ||
| Regulation | Same | 21 CFR 866.3740 |
| Streptococcus spp. Serological reagents | ||
| Product Code | Same | NJR |
| Nucleic Acid Amplification Assay System, | ||
| Group B Streptococcus , Direct Specimen | ||
| Test | ||
| Device Class | Same | I (non-exempt) |
| Technology/Detection | Same | Real-Time PCR |
| Investigational Device | Predicate Device – K060540 | |
| Attribute | Cepheid | |
| Xpert® Xpress GBS | Cepheid | |
| Xpert® GBS | ||
| Intended Use/ | ||
| Indications for | ||
| Use | The Xpert® Xpress GBS test, performed on | |
| the GeneXpert® Instrument Systems, is an | ||
| automated, real-time PCR test for the | ||
| qualitative detection of Group B | ||
| Streptococcus (GBS) DNA from | ||
| vaginal/rectal swab specimens collected | ||
| from pregnant patients for intrapartum | ||
| testing at term (e.g., >37 weeks) who have | ||
| unknown or unavailable antepartum GBS | ||
| screening test results and no additional risk | ||
| factors that would warrant empiric | ||
| antibiotic prophylaxis. The Xpert Xpress | ||
| GBS test performed during intrapartum is | ||
| intended to aid in the detection of GBS | ||
| colonization in patients presenting in labor | ||
| who may be candidates for antibiotic | ||
| prophylaxis. | ||
| The Xpert Xpress GBS test does not | ||
| provide antimicrobial susceptibility test | ||
| results. Culture is necessary to obtain | ||
| isolates to perform susceptibility testing as | ||
| recommended for penicillin-allergic | ||
| patients. | ||
| This test is conducted using direct | ||
| specimen without enrichment (enrichment | ||
| is recommended to enhance detection of | ||
| GBS colonization). In contrast to a positive | ||
| test result, which can indicate colonization, | ||
| a presumptive negative result cannot | ||
| exclude the possibility of GBS | ||
| colonization. A false negative test result at | ||
| intrapartum carries a potential harm to the | ||
| infant if it is used in making decisions | ||
| regarding empiric antibiotic prophylaxis. | ||
| Providers must use caution and default to | ||
| known patient risk factors and clinical | ||
| guidance regarding a role for intrapartum | ||
| prophylaxis. | The Cepheid Xpert GBS performed on the | |
| GeneXpert Dx System is a qualitative in | ||
| vitro diagnostic test designed to detect | ||
| Group B Streptococcus (GBS) DNA from | ||
| vaginal/rectal swab specimens, using fully | ||
| automated real-time polymerase chain | ||
| reaction (PCR) with fluorogenic detection | ||
| of the amplified DNA. | ||
| Xpert GBS Assay testing is indicated for | ||
| rapid identification of antepartum and | ||
| intrapartum GBS colonization. | ||
| The use of the Xpert GBS for | ||
| intrapartum screening should not | ||
| preclude the use of other strategies | ||
| (e.g., antepartum testing). Intrapartum | ||
| Xpert GBS results are useful to | ||
| identify candidates for intrapartum | ||
| antibiotic prophylaxis when | ||
| administration of intravenous | ||
| antibiotics is not delayed pending | ||
| results. The Xpert GBS Assay does not | ||
| provide susceptibility results. Culture | ||
| isolates are needed for performing | ||
| susceptibility testing as recommended | ||
| for penicillin-allergic women. | ||
| Assay Targets | Dual target assay design against two | |
| conserved sequences in S. agalactiae : | ||
| a member of the glycosysl transferase | ||
| gene family and a LysR transcriptional regulator | 3' region adjacent to cfb gene CAMP- | |
| factor hemolysin gene of S. agalactiae | ||
| Specimen Type | Same | Direct from vaginal/rectal swab specimens |
| Collection | ||
| Device | Same | Cepheid Collection Device with |
| Liquid Stuart Medium | ||
| Attribute | Investigational Device | |
| Cepheid | ||
| Xpert® Xpress GBS | Predicate Device – K060540 | |
| Cepheid | ||
| Xpert® GBS | ||
| Single Use | ||
| Cartridge | Same | Yes |
| Automated | ||
| Nucleic Acid | ||
| Extraction, | ||
| Detection and | ||
| Results | ||
| Interpretation | Same | Yes |
| Assay Results | Same | Qualitative |
| Internal | ||
| Controls | Sample Processing Control (SPC) | |
| Sample Adequacy Control (SAC) | ||
| Probe Check Control (PCC) | Sample Processing Control (SPC) | |
| Internal Control (IC) | ||
| Probe Check Control (PCC) | ||
| Instrument | ||
| Systems | Cepheid GeneXpert® Instrument Systems | |
| (Dx and Infinity) | Cepheid GeneXpert® Dx Systems | |
| Early Assay | ||
| Termination | ||
| (EAT) Feature | Yes | |
| EAT feature returns a high titer sample in | ||
| ~ 30 minutes | No | |
| Time to Result | 1x105 units/mL (tachyzoites, IU or copies/mL). Genomic DNA was tested at > 1x10° copies/mL. The panel of 129 organisms were tested either individually or in pools of 2 - 6 microorganisms in simulated sample matrix, both in presence of GBS at 3x LoD and in absence of GBS. Each pool was tested in replicates of 6. No cross-reactivity or microbial interference of GBS detection was observed with any of the clinically relevant pathogens tested in the study. |
| Organism | ||
|---|---|---|
| Arcanobacterium (Trueperella) | ||
| pyogenes | Haemophilus influenzae | Serratia marcescens |
| Atopobium (Fannyhessea) vaginae | Hafnia alvei | Shigella flexneri |
| Abiotrophia defectiva | Hepatitis B virus | Shigella sonnei |
| Acinetobacter baumannii | Hepatitis C virus | Staphylococcus aureus a |
| Acinetobacter lwoffii | Human immunodeficiency virus | Staphylococcus epidermidis |
| Actinobacillus pleuropneumoniae | Human Papillomavirus 18 b | Staphylococcus haemolyticus |
| Aeromonas hydrophila | Klebsiella (Enterobacter) | |
| aerogenes | Staphylococcus intermedius | |
| Alcaligenes faecalis | Klebsiella oxytoca | Staphylococcus lugdunensis |
| Anaerococcus lactolyticus | Klebsiella pneumoniae | Staphylococcus saprophyticus |
| Anaerococcus prevotii b | Lactobacillus acidophilus | Staphylococcus simulans |
| Anaerococcus tetradius | Lactobacillus casei | Stenotrophomonas maltophilia |
| Bacillus cereus | Lactobacillus delbrueckii lactis | Streptococcus acidominimus |
| Bacillus coagulans | Lactobacillus gasseri | Streptococcus anginosus |
| Bacteroides fragilis | Lactobacillus plantarum | Streptococcus bovis |
| Bifidobacterium | ||
| adolescentis Reuter | Lactobacillus reuteri | Streptococcus canis |
| Bifidobacterium brevis | Listeria monocytogenes | Streptococcus constellatus |
| BK virus | Micrococcus luteus | Streptococcus criceti |
| Blastocystis hominis b | Mobiluncus curtisii subsp. Curtisii b | Streptococcus cristatus |
| Bordetella pertussis | Moraxella atlantae | Streptococcus downei |
| Burkholderia cepacia | Moraxella catarrhalis | Streptococcus dysgalactiae |
| subsp. dysgalactiae | ||
| Campylobacter jejuni | Morganella morganii | Streptococcus dysgalactiae |
| subsp. equisimilis | ||
| Candida albicans | Mycoplasma genitalium b | Streptococcus equi subsp. equi |
Table 5-3: Analytical Specificity of Xpert Xpress GBS
CONFIDENTIAL
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Traditional 510(k) Submission
| Organism | ||
|---|---|---|
| Candida glabrata | Neisseria gonorrhoeae | Streptococcus gordonii |
| Candida tropicalis | Norovirus | Streptococcus intermedius |
| Chlamydia trachomatis | Pantoea agglomerans | Streptococcus mitis |
| Citrobacterfreundii | Pasteurellaaerogenes | Serratia liquefaciens |
| Clostridiumdifficile | Peptoniphilus asaccharolyticus | Streptococcus mutans |
| Cytomegalovirus | Peptostreptococcus anaerobius | Streptococcus oralis |
| Corynebacterium accolens | Porphyromonas asaccharolytica | Streptococcus parasanguinis |
| Corynebacterium sp. (genitalium) | Prevotella bivia | Streptococcus pneumoniae |
| Corynebacterium urealyticum | Prevotella melaninogenica | Streptococcus pseudoporcinus |
| Cryptococcus neoformans | Prevotella oralis | Streptococcus pyogenesb |
| Enterobacter cloacae | Propionibacterium acnes | Streptococcus ratti |
| Enterococcus durans | Proteus mirabilis | Streptococcus salivarius |
| Enterococcus faecalis | Proteus vulgaris | Streptococcus sanguinis |
| Enterococcus faecium | Providencia stuartiib | Streptococcus sobrinus |
| Enterococcus gallinarum | Providencia sp. | Streptococcus suis |
| Epstein-Barr virus | Pseudomonas aeruginosa | Streptococcus uberis |
| Escherichia coli | Pseudomonas fluorescens | Streptococcus vestibularis |
| Finegoldia magna | Rhodococcus equi | Toxoplasma gondii |
| Fusobacterium nucleatum | Rubella virus | Trichomonas vaginalis |
| Gardnerella vaginalis | Salmonella enterica subsp. enterica | |
| ser. Dublin (group D) | Vibrio cholerae | |
| Giardia lambliab | Salmonella enterica subp. | |
| typhimurium | Yersinia enterocolitica subsp. | |
| palearctica |
Tested