(146 days)
The document does not explicitly list "Reference Device(s)". However, it compares the subject device to the predicate device in detail.
No
The description focuses on automated real-time PCR and fluorogenic detection, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic test designed to detect the presence of Group B Streptococcus DNA, which is used for rapid identification of colonization, not for treating a condition.
Yes
The device is explicitly described as a "qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA" and its "testing is indicated for rapid identification of antepartum and intrapartum GBS colonization." The "Intended Use / Indications for Use" section clearly states its diagnostic purpose.
No
The device description explicitly details hardware components including a multi-chambered cartridge, reagents, and the GeneXpert Dx System instrument which performs sample preparation, thermal cycling, and optical detection. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Cepheid Xpert GBS performed on the GeneXpert is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens..."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Cepheid Xpert GBS performed on the GeneXpert 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.
Product codes (comma separated list FDA assigned to the subject device)
NJR
Device Description
The Xpert GBS™ is a rapid, fully-automated DNA test for detecting GBS directly from vaginal/rectal swab specimens from pregnant women. A swab containing the specimen is inserted into an individual single-use multi-chambered cartridge (the Xpert GBSTM cartridge) along with the specified single-use reagents (Reagent 1 and Reagent 2) that are provided with the assay. The user initiates a test from the system user interface, the instrument signals the user where to place the cartridge by flashing a green light, and the cartridge is placed into the indicated module in the GeneXpert Dx System instrument. The GeneXpert Dx System has 1 to 4 randomly accessible modules, each of which can process one sample. The instrument moves the sample and reagents to and from different chambers within the Xpert GBS™ cartridge for sample preparation, hydrates dry reagent beads containing critical components, fills the reaction tube with the final reaction mixture, and performs optical probe checks to ensure proper tube fill and presence of probes. The reaction mixture is then subjected to PCR thermal cycling and real-time detection of DNA. The Xpert GBS™ completes sample preparation and real-time PCR for GBS in approximately 75 minutes.
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
pregnant women, antepartum and intrapartum women
Intended User / Care Setting
Labor and Delivery Nurses and moderate complexity laboratory technologists
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
Performance characteristics of the Xpert GBS Assay were determined in a multi-site prospective investigational study at six institutions with maternity services in the United States. Each institution had a culture-based or nucleic acid test (NAT) based screening program. Testing was done in clinical laboratories affiliated with each institution as well as the labor and delivery area. Both intrapartum and antepartum subjects were included in the study. To be enrolled in the intrapartum portion of the study, women had to provide written consent, be in labor, and have no contraindication to vaginal examination (for example, bleeding). To be enrolled in the antepartum portion of the study, women had to provide written consent, be at 35-37 weeks gestation, and have no contraindication to vaginal examination (for example, bleeding). There was also no evidence of placenta previa, no urgent indication to proceed to delivery, and no antibiotic used in the week prior to admission for all subjects.
The method of reference used was the culture technique recommended by the Centers for Disease Control and Prevention (CDC): microbiological culture in selective broth medium (LIM broth, which is Todd-Hewitt broth supplemented with 15 ug/mL of nalidixic acid, and 10 ug/mL of colistin), followed by overnight incubation and subculture onto solid blood agar medium. Specific identification of colonies suggestive of GBS was done with slide agglutination tests.
The performance characteristics of the Xpert GBS Assay were determined from the results of 784 maternity patients: 366 antepartum and 418 intrapartum.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Specificity:
Genomic DNA from 101 strains representing 28 Streptococci, 73 other species including strains phylogenetically related to Streptococcus agalactiae, other microflora (bacteria and yeasts) commonly found in vaginal and anal flora, and human DNA were tested. Replicates of three were tested at 1.5 ng/25 µL reaction (~2 × 10° equivalent genome copies per reaction). None of the 28 Streptococcal isolates (non-GBS) tested positive. Of the remaining 73 strains, four (Enterococcus gallinarium, Staphylococcus simulans, Micrococcus luteus, and Propionibacterium acnes) were weakly positive in one of six replicates.
Analytical Sensitivity:
The analytical sensitivity, or limit of detection (LoD), was determined using 11 Streptococcus agalactiae strains representing nine known serotypes. Quantitated culture and purified genomic DNA were tested in four replicates. The LoD is 25 genome copies per reaction, or stated another way as about 4-8 CFU per reaction depending upon strain type.
Clinical Study:
Study type: Multi-site prospective investigational study
Sample size: 784 maternity patients (366 antepartum and 418 intrapartum)
Overall Results (Overall Sample Size: 784):
Comparison of Xpert GBS Assay and the CDC culture technique.
- Sensitivity: 91.1% (95% CI = 86.1-94.7%)
- Specificity: 96.0% (95% CI = 94.0-97.4%)
- Accuracy: 94.8% (95% CI = 93.0-96.2%)
- Prevalence: 24.2% (95% CI = 21.3-27.4%)
Intrapartum Results (Sample Size: 418):
Comparison of Xpert GBS Assay and the CDC culture technique.
- Sensitivity: 94.6% (95% CI = 87.9–98.2%)
- Specificity: 94.8% (95% CI = 91.8–96.9%)
- Accuracy: 94.7% (95% CI = 92.1–96.7%)
- Prevalence: 22.2% (95% CI = 18.4–26.5%)
Antepartum Results (Sample Size: 366):
Comparison of Xpert GBS Assay and the CDC culture technique.
- Sensitivity: 87.6% (95% CI = 79.4-93.4%)
- Specificity: 97.4% (95% CI = 94.7-98.9%)
- Accuracy: 94.8% (95% CI = 92.0-96.8%)
- Prevalence: 26.5% (95% CI = 22.1-31.3%)
Reproducibility:
A panel of four simulated specimens with varying concentrations of GBS were tested in triplicate on 10 different days at each of the three sites (4 specimens × 3 × 10 days × 3 sites). One lot of reagent was used for the study.
- Total Agreement: 360/360
- Total % Agreement: 100%
Key results: The results of the nonclinical and clinical studies discussed above demonstrate that the device is as safe, as effective, and performs as well or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall:
Sensitivity: 91.1% (95% CI = 86.1-94.7%)
Specificity: 96.0% (95% CI = 94.0-97.4%)
Accuracy: 94.8% (95% CI = 93.0-96.2%)
Prevalence: 24.2% (95% CI = 21.3-27.4%)
Intrapartum:
Sensitivity: 94.6% (95% CI = 87.9–98.2%)
Specificity: 94.8% (95% CI = 91.8–96.9%)
Accuracy: 94.7% (95% CI = 92.1–96.7%)
Prevalence: 22.2% (95% CI = 18.4–26.5%)
Antepartum:
Sensitivity: 87.6% (95% CI = 79.4-93.4%)
Specificity: 97.4% (95% CI = 94.7-98.9%)
Accuracy: 94.8% (95% CI = 92.0-96.8%)
Prevalence: 26.5% (95% CI = 22.1-31.3%)
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.
IDI-Strep B™ Assay [510(k) no. K022504]
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.
The document does not explicitly list "Reference Device(s)". However, it compares the subject device to the predicate device in detail.
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
5.0 510(k) Summary
As required by 21 CFR Section 807.92(c).
| Submitted by: | Cepheid
904 Caribbean Drive
Sunnyvale, CA 90489
Phone number: (408) 400-8230
Fax number: (408) 541-6439 | JUL 25 200 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------|
| Contact: | Russel K. Enns, Ph.D. | |
| Date of Preparation: | February 28, 2006 | |
| Device: | | |
| Trade name: | Xpert GBS™ | |
| Common name: | Group B Strep (GBS) Assay | |
| Classification name: | Nucleic Acid Amplification Assay System, Group B
Streptococcus, Direct Specimen Test | |
| Regulation number: | 866.3740 | |
| Procode: | NJR | |
| Classification
Advisory Committee: | Microbiology | |
| Predicate Device: | IDI-Strep B™ Assay [510(k) no. K022504] | |
Device Description:
The Xpert GBS™ is a rapid, fully-automated DNA test for detecting GBS directly from vaginal/rectal swab specimens from pregnant women. A swab containing the specimen is inserted into an individual single-use multi-chambered cartridge (the Xpert GBSTM cartridge) along with the specified single-use reagents (Reagent 1 and Reagent 2) that are provided with the assay. The user initiates a test from the system user interface, the instrument signals the user where to place the cartridge by flashing a green light, and the cartridge is placed into the indicated module in the GeneXpert Dx System instrument. The GeneXpert Dx System has 1 to 4 randomly accessible modules, each of which can process one sample. The instrument moves the sample and reagents to and from different chambers within the Xpert GBS™ cartridge for sample preparation, hydrates dry reagent beads containing critical components, fills the reaction tube with the final reaction mixture, and performs optical probe checks to ensure proper tube fill and presence of probes. The reaction mixture is then subjected to PCR thermal cycling and real-time detection of DNA. The Xpert GBS™ completes sample preparation and real-time PCR for GBS in approximately 75 minutes.
Device Intended Use:
1
CONFIDENTIAL
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 in vaginal/rectal specimens. The test utilizes automated real-time polymerase chain reaction (PCR) for a unique gene specific sequence amplification of Streptococcus agalactiae recovered from clinical samples and fluorogenic target-specific hybridization for the detection of the amplified DNA. Results from the Xpert GBS™ are intended for use as a method for rapid detection of GBS colonization in antepartum and intrapartum women.
Substantial Equivalence:
The Xpert GBSTM is substantially equivalent to the Infectio Diagnostic Inc. IDI-Strep BTM Assay (K022504). Both assays detect Group B Streptococcus; both assays recommend the use of Copan Collection and Transport Liquid Stuarts medium for specimen collection; both assays determine the presence of GBS through real-time PCR amplification and fluorogenic target-specific hybridization detection.
The Xpert GBS™ is fully-automated using the Cepheid GeneXpert Dx System instrument. The IDI-Strep BTM Assay is semi-automated using the Cepheid SmartCycler® System instrument. Both instruments employ the same principle I-CORE® design for controlling the real-time PCR amplification and fluorogenic targetspecific hybridization detection.
A multi-center study (Protocol 101, Rev. 5) was conducted on vaginal/rectal swab specimens collected from 418 women admitted for delivery (intrapartum) and from 366 women at 35-37 weeks gestation (antepartum). The samples were evaluated with the Xpert GBS™ and the IDI-Strep BTM Assay. Broth culture was also performed for informational purposes. The test results showed the two assays to be substantially equivalent.
Table 5-1 shows the similarities and differences between the Xpert GBS™ and the IDI-Strep BTM Assay.
| Xpert GBS TM | IDI-Strep BTM Assay | |
|---|---|---|
| Regulation no. | ||
| /Procode | 21 CFR 866.3740 | |
| /NJR | same | |
| Device | ||
| Classification | ||
| Name | Nucleic Acid Amplification Assay | |
| System, Group B Streptococcus, | ||
| Direct Specimen Test | same | |
| Xpert GBSTM | IDI-Strep BTM Assay | |
| Intended Use | The Cepheid® Xpert GBSTM | |
| performed on the GeneXpert Dx | ||
| System is a qualitative in vitro | ||
| diagnostic test designed to detect | ||
| Group B streptococcus (GBS) DNA in | ||
| vaginal/rectal specimens. The test | ||
| utilizes automated real-time | ||
| polymerase chain reaction (PCR) for a | ||
| unique gene specific sequence | ||
| amplification of Streptococcus | ||
| agalactiae recovered from clinical | ||
| samples and fluorogenic target- | ||
| specific hybridization for the | ||
| detection of the amplified DNA. | ||
| Results from the Xpert GBSTM are | ||
| intended for use as a method for rapid | ||
| detection of GBS colonization in | ||
| antepartum and intrapartum women. | A qualitative in vitro diagnostic | |
| test for the rapid detection of | ||
| Group B streptococcus (GBS) in | ||
| vaginal/rectal specimens from | ||
| antepartum or intrapartum women. | ||
| The test performed on the | ||
| SmartCycler® automated analyzer | ||
| utilizes polymerase chain reaction | ||
| (PCR) for the amplification of a | ||
| cfb gene sequence of GBS | ||
| recovered from clinical samples | ||
| and fluorogenic target-specific | ||
| hybridization for the detection of | ||
| the amplified DNA. | ||
| IDI-Strep BTM Assay can be used | ||
| to establish GBS colonization | ||
| status of antepartum and | ||
| intrapartum women. | ||
| Organism | ||
| Detection | Group B streptococcus DNA | Same |
| Specimen Type | Direct from Vaginal/rectal swab | Same |
| Collection and | ||
| Transport | ||
| Medium | Copan with Liquid Stuart Medium | Same |
| Assay Platform | Cepheid GeneXpert Dx System | Cepheid SmartCycler System |
| Assay Format | Amplification: PCR with I-CORE | |
| heating and cooling module. | ||
| Detection: Fluorogenic target-specific | ||
| hybridization | Same | |
| Self-contained | ||
| system assay | Yes | No |
| Single use | Yes; single-use Cepheid cartridge | |
| includes integrated reaction tube | Yes; single-use Cepheid reaction | |
| tube | ||
| Fully automated | ||
| assay | Yes: Sample Preparation, | |
| amplification, detection and result | ||
| interpretation | No: Sample Preparation is manual. | |
| Time to result | ≤ 75 minutes total | Approximately 60 minutes |
| Built in Lysis | ||
| control | Yes | No |
| External Assay | ||
| Controls | Materials available, but not required. | Required. |
| Xpert GBS™ | IDI-Strep B™ Assay | |
| Internal Assay | ||
| Controls | Sample Processing Control; | |
| Cepheid Internal Control; | ||
| Probe Check (all optical channels) | ||
| Failures result in single sample repeat. | Internal control | |
| Site check (1 optical channel) | ||
| Same | ||
| Fluidics | Self-contained after two single-dose | |
| reagent additions (dispense entire | ||
| contents of each). | Multiple manual pipetting, fluid | |
| transfers, vortexing, centrifugation | ||
| steps. | ||
| Criteria for Ct | ||
| determination | Primary growth curve | 2nd derivative analysis |
| Amplification | ||
| verification | Yes: curve fit check (protects against | |
| false positives due to optical noise) | None | |
| Users | Labor and Delivery Nurses and | |
| moderate complexity laboratory | ||
| technologists | Lab technologists | |
| Performance | ||
| Characteristics as | ||
| determined in the | ||
| Cepheid Clinical | ||
| Study (Protocol | ||
| 101, Rev. 5.0) in | ||
| comparison to | ||
| culture technique | ||
| (CDC) at | ||
| intrapartum | Sensitivity: 94.6% | |
| Specificity: 94.8% | As determined in the Cepheid | |
| Clinical study using the same | ||
| subjects as tested with the Xpert | ||
| GBS™: | ||
| Sensitivity: 82.4% | ||
| Specificity: 94.8% | ||
| Probes | TaqMan® Probes | Molecular beacons |
Table 5-1 Similarities and Differences Between the Xpert GBS™ and the IDI-Strep B™ Assay
2
3
Non-Clinical Studies:
Analytical Specificity
Genomic DNA from 101 strains representing 28 Streptococci, 73 other species including strains phylogenetically related to Streptococcus agalactiae, other microflora (bacteria and yeasts) commonly found in vaginal and anal flora, and human DNA were tested. Replicates of three were tested at 1.5 ng/25 µL reaction (~2 × 10° equivalent genome copies per reaction). None of the 28 Streptococcal isolates (non-GBS) tested positive. Of the remaining 73 strains, four (Enterococcus gallinarium, Staphylococcus simulans, Micrococcus luteus, and Propionibacterium acnes) were weakly positive in one of six replicates.
4
Analytical Sensitivity
The analytical sensitivity, or limit of detection (LoD), was determined using 11 Streptococcus agalactiae strains representing nine known serotypes. Quantitated culture and purified genomic DNA were tested in four replicates. The LoD is 25 genome copies per reaction, or stated another way as about 4-8 CFU per reaction depending upon strain type.
Clinical Study:
Performance characteristics of the Xpert GBS Assay were determined in a multi-site prospective investigational study at six institutions with maternity services in the United States. Each institution had a culture-based or nucleic acid test (NAT) based screening program. Testing was done in clinical laboratories affiliated with each institution as well as the labor and delivery area. Both intrapartum and antepartum subjects were included in the study. To be enrolled in the intrapartum portion of the study, women had to provide written consent, be in labor, and have no contraindication to vaginal examination (for example, bleeding). To be enrolled in the antepartum portion of the study, women had to provide written consent, be at 35-37 weeks gestation, and have no contraindication to vaginal examination (for example, bleeding). There was also no evidence of placenta previa, no urgent indication to proceed to delivery, and no antibiotic used in the week prior to admission for all subjects.
The method of reference used was the culture technique recommended by the Centers for Disease Control and Prevention (CDC): microbiological culture in selective broth medium (LIM broth, which is Todd-Hewitt broth supplemented with 15 ug/mL of nalidixic acid, and 10 ug/mL of colistin), followed by overnight incubation and subculture onto solid blood agar medium. Specific identification of colonies suggestive of GBS was done with slide agglutination tests.
The performance characteristics of the Xpert GBS Assay were determined from the results of 784 maternity patients: 366 antepartum and 418 intrapartum.
Total Results:
Vaginal/rectal specimens were collected from each subject using two sets of doublemarked swabs (Cepheid GBS Collection Devices). One of the swabs from the first set was used in the CDC-recommended culture technique. The second set of double-marked swabs was divided: one swab was used in the Xpert GBS Assay on the GeneXpert Dx System, the other was used in the IDI Strep BTM Assay on the SmartCycler® System.
To minimize swab-to-swab variation, the swabs remaining from the Xpert GBS Assay and the IDI Strep B Assay were both cultured. Sensitivity and specificity were calculated relative to the culture results.
Table 5-2 compares the overall results from the Xpert GBS Assay run on the GeneXpert Dx System and the CDC-recommended culture technique. The sensitivity and specificity data are shown below the table.
5
| T
| able 5-2 | |
|---|---|
| --------------- | -- |
| Culture | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| GeneXpert | Positive | 173 | 24 | 197 |
| Negative | 17 | 570 | 587 | |
| Total | 190 | 594 | 784 |
Comparison of Xpert GBS Assay and the CDC culture technique.
| Sensitivity: | 91.1% (95% CI = 86.1-94.7%) |
|---|---|
| Specificity: | 96.0% (95% CI = 94.0-97.4%) |
| Accuracy: | 94.8% (95% CI = 93.0-96.2%) |
| Prevalence: | 24.2% (95% CI = 21.3-27.4%) |
Intrapartum Results:
Table 5-3 compares the intrapartum culture results from the Xpert GBS Assay run on the GeneXpert Dx System and the CDC recommended culture technique. The sensitivity and specificity data are shown below the table.
Table 5-3
Comparison of Xpert GBS Assay and the CDC culture technique.
| Culture | |||||
|---|---|---|---|---|---|
| Positive | Negative | Total | |||
| GeneXpert | Positive | 88 | 17 | 105 | |
| Negative | 5 | 308 | 313 | ||
| Total | 93 | 325 | 418 |
| Sensitivity: | 94.6% (95% CI = 87.9–98.2%) |
|---|---|
| Specificity: | 94.8% (95% CI = 91.8–96.9%) |
| Accuracy: | 94.7% (95% CI = 92.1–96.7%) |
| Prevalence: | 22.2% (95% CI = 18.4–26.5%) |
6
CONFIDENTIAL
Antepartum Results:
Table 5-4 compares the antepartum culture results from the Xpert GBS Assay run on the GeneXpert Dx System and the CDC-recommended culture technique. The sensitivity and specificity data are shown below the table.
Table 5-4
Comparison of Xpert GBS Assay and the CDC culture technique
| Culture | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| GeneXpert | Positive | 85 | 7 | 92 |
| Negative | 12 | 262 | 274 | |
| Total | 97 | 269 | 366 |
| Sensitivity: | 87.6% (95% CI = 79.4-93.4%) |
|---|---|
| Specificity: | 97.4% (95% CI = 94.7-98.9%) |
| Accuracy: | 94.8% (95% CI = 92.0-96.8%) |
| Prevalence: | 26.5% (95% CI = 22.1-31.3%) |
Reproducibility:
A panel of four simulated specimens with varying concentrations of GBS were tested in triplicate on 10 different days at each of the three sites (4 specimens × 3 × 10 days × 3 sites). One lot of reagent was used for the study.
Table 5-5
| Specimen ID | Site 1 | Site 2 | Site 3 | Total
Agreement | Total %
Agreement |
|-----------------|---------|---------|---------|--------------------|----------------------|
| Negative | 30/30 | 30/30 | 30/30 | 90/90 | 100% |
| Weak Positive | 30/30 | 30/30 | 30/30 | 90/90 | 100% |
| Positive | 30/30 | 30/30 | 30/30 | 90/90 | 100% |
| Strong Positive | 30/30 | 30/30 | 30/30 | 90/90 | 100% |
| Total Agreement | 120/120 | 120/120 | 120/120 | 360/360 | 100% |
| % Agreement | 100% | 100% | 100% | 100% | 100% |
Summary of reproducibility results
Conclusions:
The results of the nonclinical and clinical studies discussed above demonstrate that the device is as safe, as effective, and performs as well or better than the predicate device.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is rendered in black. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Russel K. Enns. Ph.D. Senior Vice President Regulatory & Clinical Affairs, Quality System and Reimbursement Cepheid 904 Caribbean Drive Sunnyvale, CA 94089-1189
JUL 25 2006
Re: K060540
Trade/Device Name: Xpert GBSTM Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. serological test reagents Regulatory Class: Class I Product Code: NJR Dated: May 17, 2006 Received: May 18, 2006
Dear Dr. Enns:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its collection and (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Sally, artim
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indications for Use
Kaosy o 510{k) Number (if known): K06540
Device Name: Xpert GBS Assay
Indications For Use:
The Cepheid Xpert GBS performed on the GeneXpert 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.
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ludde. Pode
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Satery
510(k) K060540
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