(146 days)
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.
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.
Here's an analysis of the provided text to extract the acceptance criteria and study details for the Xpert GBS™ device:
Acceptance Criteria and Device Performance for Xpert GBS™
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the clinical performance characteristics presented relative to the CDC-recommended culture technique. Given that the submission is for substantial equivalence to a predicate device, the performance of the Xpert GBS™ is primarily compared to the predicate device and the gold standard culture method. Explicit, pre-defined numerical acceptance criteria are not presented in a formal "acceptance criteria" section but are evident from the reported sensitivity and specificity values.
| Performance Metric | Acceptance Criteria (Implied by Predicate/Gold Standard Comparison) | Xpert GBS™ Reported Performance (Overall) | Xpert GBS™ Reported Performance (Intrapartum) | Xpert GBS™ Reported Performance (Antepartum) |
|---|---|---|---|---|
| Sensitivity | Substantially equivalent to predicate, and sufficiently high compared to CDC culture for GBS detection. (Predicate: 82.4%) | 91.1% (95% CI = 86.1-94.7%) | 94.6% (95% CI = 87.9–98.2%) | 87.6% (95% CI = 79.4-93.4%) |
| Specificity | Substantially equivalent to predicate, and sufficiently high compared to CDC culture for GBS detection. (Predicate: 94.8%) | 96.0% (95% CI = 94.0-97.4%) | 94.8% (95% CI = 91.8–96.9%) | 97.4% (95% CI = 94.7-98.9%) |
| Reproducibility | High agreement across sites and days for varying GBS concentrations. | 100% agreement across 3 sites, 10 days, 4 specimen types (Negative, Weak Positive, Positive, Strong Positive) | 100% agreement across 3 sites, 10 days, 4 specimen types (Negative, Weak Positive, Positive, Strong Positive) | 100% agreement across 3 sites, 10 days, 4 specimen types (Negative, Weak Positive, Positive, Strong Positive) |
| Analytical Sensitivity (LoD) | Clear limit of detection for target organism. | 25 genome copies per reaction (~4-8 CFU per reaction) | N/A | N/A |
| Analytical Specificity | No cross-reactivity with common vaginal/anal flora or phylogenetically related species. | No positive results for 28 non-GBS Streptococcal isolates. Weakly positive in 1/6 replicates for 4 out of 73 other strains (Enterococcus gallinarium, Staphylococcus simulans, Micrococcus luteus, Propionibacterium acnes). | N/A | N/A |
2. Sample Sizes Used for the Test Set and Data Provenance
- Clinical Study Test Set Sample Size: 784 maternity patients
- 366 antepartum subjects
- 418 intrapartum subjects
- Data Provenance: Prospective investigational study conducted at six institutions with maternity services in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth was established by a culture technique recommended by the Centers for Disease Control and Prevention (CDC). This implies standard laboratory personnel performing the culture, rather than a panel of clinical experts adjudicating cases.
4. Adjudication Method for the Test Set
- None, in the sense of expert review or consensus. The ground truth was determined solely by the CDC-recommended culture method, which is a laboratory standard rather than an adjudicated clinical finding.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone diagnostic assay (Nucleic Acid Amplification Assay System) and not an AI-assisted diagnostic tool for human interpretation. The comparison was between the new assay (Xpert GBS™), a predicate assay (IDI-Strep B™ Assay), and a standard culture method.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the clinical study evaluated the Xpert GBS™ Assay as a standalone diagnostic device. Its performance was measured directly against the CDC-recommended culture technique. It is a "fully-automated DNA test" where the instrument completes "sample preparation and real-time PCR for GBS in approximately 75 minutes," and provides "result interpretation."
7. The Type of Ground Truth Used
- Expert Consensus Pathology / Clinical Outcomes Data: The ground truth for the clinical study was established by a culture technique recommended by the Centers for Disease Control and Prevention (CDC). This involved:
- Microbiological culture in selective broth medium (LIM broth).
- Overnight incubation.
- Subculture onto solid blood agar medium.
- Specific identification of colonies suggestive of GBS with slide agglutination tests.
8. The Sample Size for the Training Set
- The document does not explicitly state a separate training set size for the Xpert GBS™ assay. This is typical for PCR-based diagnostic assays, where a "training set" in the machine learning sense isn't used. Instead, assay development involves analytical studies (specificity, sensitivity/LoD) and then validation with clinical samples. The "multi-center study (Protocol 101, Rev. 5)" using 784 patients serves as the primary clinical validation (test) set.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, a "training set" in the machine learning context is not applicable here. For the analytical studies (specificity, LoD), the ground truth was established by:
- Analytical Specificity: Using known genomic DNA from 101 identified strains (28 Streptococci, 73 other species including microflora and human DNA) at controlled concentrations. The "ground truth" here is the known identity of the organisms.
- Analytical Sensitivity (LoD): Using 11 Streptococcus agalactiae strains representing nine known serotypes, with quantitated culture and purified genomic DNA. The "ground truth" here is the known presence and concentration of GBS.
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5.0 510(k) Summary
As required by 21 CFR Section 807.92(c).
| Submitted by: | Cepheid904 Caribbean DriveSunnyvale, CA 90489Phone number: (408) 400-8230Fax 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 BStreptococcus, Direct Specimen Test | |
| Regulation number: | 866.3740 | |
| Procode: | NJR | |
| ClassificationAdvisory 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:
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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 |
| DeviceClassificationName | Nucleic Acid Amplification AssaySystem, Group B Streptococcus,Direct Specimen Test | same |
| Xpert GBSTM | IDI-Strep BTM Assay | |
| Intended Use | The Cepheid® Xpert GBSTMperformed on the GeneXpert DxSystem is a qualitative in vitrodiagnostic test designed to detectGroup B streptococcus (GBS) DNA invaginal/rectal specimens. The testutilizes automated real-timepolymerase chain reaction (PCR) for aunique gene specific sequenceamplification of Streptococcusagalactiae recovered from clinicalsamples and fluorogenic target-specific hybridization for thedetection of the amplified DNA.Results from the Xpert GBSTM areintended for use as a method for rapiddetection of GBS colonization inantepartum and intrapartum women. | A qualitative in vitro diagnostictest for the rapid detection ofGroup B streptococcus (GBS) invaginal/rectal specimens fromantepartum or intrapartum women.The test performed on theSmartCycler® automated analyzerutilizes polymerase chain reaction(PCR) for the amplification of acfb gene sequence of GBSrecovered from clinical samplesand fluorogenic target-specifichybridization for the detection ofthe amplified DNA.IDI-Strep BTM Assay can be usedto establish GBS colonizationstatus of antepartum andintrapartum women. |
| OrganismDetection | Group B streptococcus DNA | Same |
| Specimen Type | Direct from Vaginal/rectal swab | Same |
| Collection andTransportMedium | Copan with Liquid Stuart Medium | Same |
| Assay Platform | Cepheid GeneXpert Dx System | Cepheid SmartCycler System |
| Assay Format | Amplification: PCR with I-COREheating and cooling module.Detection: Fluorogenic target-specifichybridization | Same |
| Self-containedsystem assay | Yes | No |
| Single use | Yes; single-use Cepheid cartridgeincludes integrated reaction tube | Yes; single-use Cepheid reactiontube |
| Fully automatedassay | Yes: Sample Preparation,amplification, detection and resultinterpretation | No: Sample Preparation is manual. |
| Time to result | ≤ 75 minutes total | Approximately 60 minutes |
| Built in Lysiscontrol | Yes | No |
| External AssayControls | Materials available, but not required. | Required. |
| Xpert GBS™ | IDI-Strep B™ Assay | |
| Internal AssayControls | Sample Processing Control;Cepheid Internal Control;Probe Check (all optical channels)Failures result in single sample repeat. | Internal controlSite check (1 optical channel)Same |
| Fluidics | Self-contained after two single-dosereagent additions (dispense entirecontents of each). | Multiple manual pipetting, fluidtransfers, vortexing, centrifugationsteps. |
| Criteria for Ctdetermination | Primary growth curve | 2nd derivative analysis |
| Amplificationverification | Yes: curve fit check (protects againstfalse positives due to optical noise) | None |
| Users | Labor and Delivery Nurses andmoderate complexity laboratorytechnologists | Lab technologists |
| PerformanceCharacteristics asdetermined in theCepheid ClinicalStudy (Protocol101, Rev. 5.0) incomparison toculture technique(CDC) atintrapartum | Sensitivity: 94.6%Specificity: 94.8% | As determined in the CepheidClinical study using the samesubjects as tested with the XpertGBS™: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
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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.
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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.
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| Table 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%) |
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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 | TotalAgreement | 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.
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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).
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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
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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
Page 1 of _ /
§ 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.