Simplexa GBS Direct, Simplexa GBS Positive Control Pack
Device Facts
| Record ID | K182467 |
|---|---|
| Device Name | Simplexa GBS Direct, Simplexa GBS Positive Control Pack |
| Applicant | Diasorin Molecular, LLC |
| Product Code | NJR · Microbiology |
| Decision Date | Nov 7, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
Intended Use
The DiaSorin Molecular Simplexa™ GBS Direct assay is a real-time polymerase chain reaction (PCR) assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of Group B Streptococcus (GBS) nucleic acid from 18 to 24 hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can be used as an aid in determining the colonization status of antepartum women, but are not intended to diagnose or monitor treatment of a GBS infection. The Simplexa™ GBS Direct assay does not provide susceptibility results. Culture isolates are needed to perform susceptibility testing as recommended for penicillin-allergic women. The Simplexa™ GBS Positive Control Pack is intended to be used as a control with the Simplexa™ GBS Direct kit. This control is not intended for use with other assays or systems.
Device Story
The Simplexa GBS Direct assay is a real-time PCR system for qualitative detection of Group B Streptococcus (GBS) DNA. It processes 18-24 hour Lim broth-enriched vaginal/rectal swabs without prior nucleic acid extraction. The system comprises the assay reagents, LIAISON MDX instrument, and Direct Amplification Discs (DAD). Primers and fluorescent probes target the cfb gene; an Internal Control (DNA IC) monitors for PCR failure or inhibition. The device is used in clinical laboratories by trained personnel. Results aid in determining antepartum GBS colonization status. The system provides automated sample-to-answer processing. By identifying GBS colonization, the device assists clinicians in managing GBS-related risks during pregnancy, though it does not replace the need for culture-based susceptibility testing in penicillin-allergic patients.
Clinical Evidence
Prospective clinical study of 432 samples compared Simplexa GBS Direct to a GBS culture reference method. Sensitivity was 97.0% (95% CI: 91.5% to 99.0%) and specificity was 96.1% (95% CI: 93.4% to 97.7%). Invalid rate was 0.0%. Reproducibility was assessed across three sites using contrived samples, showing high agreement (99.6% overall). Analytical studies included LoD determination, cross-reactivity testing against 74 organisms, and interference testing with 26 substances.
Technological Characteristics
Real-time PCR assay; frozen liquid reagent format. Uses LIAISON MDX instrument with DAD (Direct Amplification Disc) consumables. Sensing via fluorescence-based detection of cfb gene. Software-controlled automated amplification and interpretation. No end-user calibration required; optical module calibration stored in firmware.
Indications for Use
Indicated for qualitative detection of GBS nucleic acid in 18-24 hour Lim broth-enriched vaginal/rectal swabs from antepartum women to determine colonization status. Not for diagnosing or monitoring GBS infection. Does not provide susceptibility results; culture required for penicillin-allergic patients.
Regulatory Classification
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 identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus 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.
Predicate Devices
- GenePOC GBS LB Assay (K170557)
Related Devices
- K090191 — HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB · Handylab, Inc. · May 27, 2010
- K062948 — SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B · Cepheid · Dec 8, 2006
- K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENT · Becton, Dickinson & CO · Feb 16, 2012
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 7, 2018
DiaSorin Molecular LLC Sharon Young Principal Regulatory Affairs Specialist 11331 Vallev View Street Cypress, California 90630
### Re: K182467
Trade/Device Name: Simplexa GBS Direct, Simplexa GBS Positive Control Pack Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. Serological Reagents Regulatory Class: Class I Product Code: NJR, OOI Dated: September 5, 2018 Received: September 10, 2018
Dear Sharon Young:
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/cdrl/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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
#### Steven R. Gitterman -S for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K182467
Device Name Simplexa™ GBS Direct Simplexa™ GBS Positive Control Pack
## Indications for Use (Describe)
Simplexa™ GBS Direct
The DiaSorin Molecular Simplexa™ GBS Direct assay is a real-time polymerase chain reaction (PCR) assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of Group B Streptococcus (GBS) nucleic acid from 18 to 24 hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can be used as an aid in determining the colonization status of antepartum women, but are not intended to diagnose or monitor treatment of a GBS infection.
The Simplexa™ GBS Direct assay does not provide susceptibility results. Culture isolates are needed to perform susceptibility testing as recommended for penicillin-allergic women.
Simplexa™ GBS Positive Control Pack
The Simplexa™ GBS Positive Control Pack is intended to be used as a control with the Simplexa™ GBS Direct kit. This control is not intended for use with other assays or systems.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue, with "Molecular" underneath in green. The logo is clean and modern, representing the company's focus on molecular diagnostics.
### 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 1 of 19
| Applicant | DiaSorin Molecular LLC.<br>11331 Valley View Street<br>Cypress, California 90630<br>USA |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Sharon Young<br>Principal Regulatory Affairs Specialist<br>tel 562.240.6680<br>fax 562.240.6529<br>Sharon.Young@DiaSorin.com |
| Summary Date | October 25 2018 |
| Proprietary Name | Simplexa™ GBS Direct and Simplexa™ GBS Positive Control Pack |
| Generic Name | Nucleic Acid Amplifications System, Group B Streptococcus, Direct<br>Specimen Testing |
| Classification | Class I |
| Predicate Devices | GenePOC GBS LB Assay K170557 |
#### Intended Use
#### Simplexa™ GBS Direct
The DiaSorin Molecular Simplexa™ GBS Direct assay is a real-time polymerase chain reaction (PCR) assay intended for use on the LIAISON® MDX instrument for the in vitro qualitative detection of Group B Streptococcus (GBS) nucleic acid from 18 to 24 hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Assay results can aid in determining the colonization status of antepartum women, but are not intended to diagnose or monitor treatment of a GBS infection.
The Simplexa™ GBS Direct assay does not provide susceptibility results. Culture isolates are needed to perform susceptibility testing as recommended for penicillin-allergic women.
#### Simplexa™ GBS Positive Control Pack
The Simplexa™ GBS Positive Control Pack is intended to be used as a control with the Simplexa™ GBS Direct kit. This control is not intended for use with other assays or systems.
#### Device Description
The Simplexa™ GBS Direct assay system is a real-time PCR system that enables the direct amplification and qualitative detection of Group B Strep bacterial DNA from vaginal swabs enriched in Lim Broth for eighteen to twenty-four (18 to 24) hours that have not undergone a nucleic acid extraction. The system consists of the Simplexa™ GBS Direct assay, the LIAISON® MDX (with LIAISON® MDX Studio Software), the Direct Amplification Disc (DAD) and associated accessories.
In the Simplexa™ GBS Direct assay, primers and fluorescent probes are used together to amplify Group B Streptococcus bacterial DNA and the Internal Control (DNA IC). The assay targets a conserved region of the cfb gene to identify Group B Streptococus in the specimen. The DNA IC is used to detect PCR failure and/or inhibition.
| Component Name | REF | EC SYMBOL<br>ON LABEL | Abbreviated<br>Name | Cap<br>Color | Number of<br>Vials | Reactions<br>per<br>Vial/Kit | Volume<br>per Vial |
|-----------------------------------------|---------|-----------------------|---------------------|--------------|--------------------|------------------------------|--------------------|
| Simplexa™ GBS<br>Direct<br>Reaction Mix | MOL3551 | REAG<br>C | RM | Orange | 24 | 1/24 | 50 μL |
#### Kit Description
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Image /page/4/Picture/0 description: The image contains the logo for DiaSorin Molecular. The logo features a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in a dark blue, sans-serif font, stacked above the word "Molecular" in a lighter green, sans-serif font.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 2 of 19
#### Component Description
| Kit Component | Contents | | | | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------|----------|---------------|
| Simplexa™ GBS<br>Direct Reaction<br>Mix (RM) | DNA polymerase, buffers, dNTPs, Internal Control DNA Template, dye-labeled fluorescent<br>primers and probes specific for detection of Group B Strep and for the DNA Internal Control | | | | |
| | Target | Probe<br>Fluorophore<br>(Dye) | Excitation | Emission | Targeted Gene |
| | GBS | CFR610 | 590 | 610 | cfb |
| | Internal<br>Control<br>DNA (IC) | Q670 | 644 | 670 | NA |
| Simplexa™ GBS<br>Direct Barcode<br>Card | Assay specific parameters, lot number, expiration date. | | | | |
#### MATERIALS SUPPLIED SEPARATELY
Direct Amplification Disc Kit (REF) MOL1455) Direct Amplification Discs for use on the LIAISON® MDX
#### Predicate Device Information
| Similarities | | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate Device | Predicate Device:<br>GenePOC GBS LB Assay K170557 | Candidate Device:<br>Simplexa™ GBS Direct and<br>Simplexa™ GBS Positive Control Pack |
| Product Code | NJR and OOI<br>21 CFR 866.3740 - Streptococcal spp.<br>serological reagents<br>21 CFR 862.2570 - Instrumentation for<br>clinical multiplex test systems | Same |
| Organism<br>Detected | Group B Streptococcus | Same |
| Measurand | Target DNA sequence in cfb gene of<br>Streptococcus agalactiae (Group B<br>Streptococcus, GBS) | Conserved region of the cfb gene of<br>Streptococcus agalactiae (Group B<br>Streptococcus, GBS) |
| Intended Use | The GenePOC GBS LB assay<br>performed on the revogene instrument<br>is a qualitative in vitro diagnostic test<br>designed to detect Group B<br>Streptococcus (GBS) DNA from 18-24<br>hour LIM broth enrichments of<br>vaginal/rectal specimen swabs | The DiaSorin Molecular Simplexa™ GBS<br>Direct assay is a real-time polymerase<br>chain reaction (PCR) assay intended for<br>use on the LIAISON® MDX instrument<br>for the in vitro qualitative detection of<br>Group B Streptococcus (GBS) nucleic<br>acid from 18 to 24 hour Lim broth |
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Image /page/5/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green on the left. To the right of the DNA helix are the words "DiaSorin" in dark blue on the top line and "Molecular" in light green on the bottom line.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 3 of 19
| Similarities | | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>Predicate Device | Predicate Device:<br>GenePOC GBS LB Assay K170557 | Candidate Device:<br>Simplexa™ GBS Direct and<br>Simplexa™ GBS Positive Control Pack |
| | obtained from pregnant women. The<br>GenePOC GBS LB assay utilizes<br>automated sample processing and<br>real-time polymerase chain reaction<br>(PCR) to detect a cfb gene sequence<br>specific to the Streptococcus<br>agalactiae genome. The GenePOC<br>GBS LB assay is indicated for the<br>identification of antepartum GBS<br>colonization and does not provide<br>susceptibility results. It is not intended<br>to diagnose or monitor treatment of<br>GBS infection. Culture isolates are<br>needed for performing susceptibility<br>testing as recommended for penicillin-<br>allergic women. | enrichments of vaginal/rectal specimen<br>swabs obtained from antepartum<br>women. Assay results can be used as an<br>aid in determining the colonization status<br>of antepartum women, but are not<br>intended to diagnose or monitor<br>treatment of a GBS infection.<br><br>The Simplexa™ GBS Direct assay does<br>not provide susceptibility results. Culture<br>isolates are needed to perform<br>susceptibility testing as recommended for<br>penicillin-allergic women.<br><br>Simplexa™ GBS Positive Control Pack<br>The Simplexa™ GBS Positive Control<br>Pack is intended to be used as a control<br>with the Simplexa™ GBS Direct kit.<br><br>This control is not intended for use with<br>other assays or systems. |
| Automated<br>System (Sample<br>to Answer) | Yes | Yes |
| Differences | | |
|--------------------------------------|---------------------------------------|-------------------------------------------------------------------------------|
| Comparison to<br>Predicate<br>Device | GenePOC GBS LB Assay K170557 | Simplexa™ GBS Direct and<br>Simplexa™ GBS Positive Control<br>Pack |
| Instrumentation | Revogene instrument | LIAISON® MDX |
| Single Use | Yes Cartridge (PIE) can be used once. | No. Consumable disc can be used until<br>all eight (8) wedges have been used. |
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Image /page/6/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue on the top line and "Molecular" in green on the bottom line. The text is aligned to the right of the DNA helix.
### 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 4 of 19
#### CLINICAL PERFORMANCE
The performance of the Simplexa™ GBS Direct assay was evaluated in a prospective study that was conducted with residual de-identified Lim broth enrichment cultures of vaginal/rectal swabs obtained from pregnant women at thirty-five to thirty-seven (35-37) weeks of gestation. The specimens were collected and enriched according to established CDC guidelines. Lim Broth cultures were incubated for eighteen to twenty-four (18-24) hours at 35-37 °C. Four hundred and thirty-two (432) samples that met the prescribed inclusion criteria were used to evaluate the performance of the Simplexa™ GBS Direct assay in comparison to those obtained with a GBS culture reference method. All samples were tested fresh upon completion of the enrichment process. Aliquots were made from each freshly enriched Lim Broth sample; the first aliquot was held at 2-8 °C and tested on the Simplexa™ GBS Direct at the collection site, and the second aliquot was kept at 2-8 °C and sent on cold packs to a central laboratory for GBS culture.
For the GBS culture reference method, enriched Lim Broth samples were sub-cultured to selective and non-selective blood agar for twenty-four (24) hours. If GBS was not observed, the plates were reincubated for an additional twenty-four (24) hours and deemed negative if GBS was not identified. Colonies with an appearance that was suggestive of GBS were further processed to confirm the presence of GBS using general laboratory methods, which included: gram stain, catalase testing, and latex agglutination.
The testing of samples with Lim broth incubation periods per CDC guidelines included eighty-four (84) total runs with thirty-one (31) control pairs, all of which produced the expected positive/negative results. The invalid rate of the clinical prospective study samples with Lim broth incubation periods per CDC guidelines was 0.0%, zero out of four hundred and thirty-two (0/432). The results of the study are shown in Table 1.
| Simplexa™™ GBS<br>Direct Results | Culture Comparator Method | | |
|----------------------------------|--------------------------------------------------------|---------------------------------------------------------|-------|
| | Detected | Not Detected | Total |
| Detected | 97 | 13b | 110 |
| Not Detected | 3a | 319 | 322 |
| Total | 100 | 332 | 432 |
| | Sensitivity<br>97.0%(97/100)<br>95% CI: 91.5% to 99.0% | Specificity<br>96.1%(319/332)<br>95% CI: 93.4% to 97.7% | |
### Table 1. Clinical Agreement Summary Results - Prospective Clinical Agreement Results Simplexa™ GBS Direct vs. Culture
ª 3/3 samples with discrepant results were negative when tested with an alternate FDA cleared NAAT.
b 11/13 samples with discrepant results were positive when tested with an alternate FDA cleared NAAT.
#### REPRODUCIBILITY
Three (3) investigative sites assessed the device's inter-day and inter/intra-assay reproducibility. Each of the laboratories tested Simplexa™ GBS Direct Positive Control, No Template Control (Lim Broth), and four (4) contrived samples in negative matrix. Two (2) strains of GBS were used in the study, BAA-22 and BAA-1138. The four (4) contrived samples consisted of a low positive (LP) at approximately 1.5 x LoD and a medium positive (MP) at approximately 3.5 x LoD for each GBS strain. The assays were performed in triplicate on five (5) different days. Each site had two (2) operators who each assayed the entire sample panel and Positive Control once per day, for a total of two (2) sets of data per day on a total of six (6) LIAISON® MDX instruments. The combined results for all sites are presented in Tables 2 and 3.
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Image /page/7/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in a bold, dark blue font, with the word "Molecular" underneath in a lighter green font. The logo is clean and modern, suggesting a company involved in molecular diagnostics or biotechnology.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 5 of 19
| GBS<br>(FAM) | Site 1 | | | Site 2 | | | Site 4 | | | Total %<br>Agreement<br>with<br>Expected<br>Results | 95% CI |
|-----------------------------------------------|---------------------------------------------|--------------|-----------------------------------------------|-------------------------------------------|--------------|-----------------------------------------------|---------------------------------------------|--------------|-----|-----------------------------------------------------|--------------------|
| %<br>Agreement<br>with<br>Expected<br>Results | Avg<br>Ct | Total<br>%CV | %<br>Agreement<br>with<br>Expected<br>Results | Avg<br>Ct | Total<br>%CV | %<br>Agreement<br>with<br>Expected<br>Results | Avg<br>Ct | Total<br>%CV | | | |
| BAA-22 -<br>LP | 100.0%<br>(30/30) | 33.2 | 1.2 | 100.0%<br>(30/30) | 33.7 | 1.7 | 100.0%<br>(30/30) | 32.1 | 0.9 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| BAA-22 -<br>MP | 100.0%<br>(30/30) | 32.6 | 1.1 | 100.0%<br>(30/30) | 31.6 | 1.3 | 100.0%<br>(30/30) | 31.9 | 1.1 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| BAA-<br>1138 -<br>LP | 100.0%<br>(30/30) | 34.1 | 1.6 | 93.3%<br>(28/30) | 34.6 | 3.1 | 100.0%<br>(30/30) | 33.1 | 2.3 | 97.8%<br>(88/90) | 92.3% to<br>99.4% |
| BAA-<br>1138 -<br>MP | 100.0%<br>(30/30) | 32.7 | 1.2 | 100.0%<br>(30/30) | 33.1 | 1.4 | 100.0%<br>(30/30) | 31.9 | 1.5 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| PC | 100.0%<br>(30/30) | 30.2 | 0.6 | 100.0%<br>(30/30) | 28.7 | 0.7 | 100.0%<br>(30/30) | 29.1 | 0.7 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| NTC | 100.0%<br>(30/30) | NA | NA | 100.0%<br>(30/30) | NA | NA | 100.0%<br>(30/30) | NA | NA | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| Total<br>Agreement | 100.0% (180/180)<br>95% Cl: 97.9% to 100.0% | | | 98.9% (178/180)<br>95% Cl: 96.0% to 99.7% | | | 100.0% (180/180)<br>95% CI: 97.9% to 100.0% | | | 99.6% (538/540)<br>95% Cl: 98.7% to 99.9% | |
#### Table 2. Simplexa™ GBS Direct Reproducibility (FAM)
### Table 3. Simplexa™ GBS Direct Internal Control Reproducibility (Q670)
| | Site 1 | | | Site 2 | | | Site 4 | | | Total % | |
|----------------------------|-----------------------------------------------|-----------|--------------|-----------------------------------------------|-----------|--------------|-----------------------------------------------|-----------|--------------|------------------------------------------------|--------------------|
| Sample<br>DNA IC<br>(Q670) | %<br>Agreement<br>with<br>Expected<br>Results | Avg<br>Ct | Total<br>%CV | %<br>Agreement<br>with<br>Expected<br>Results | Avg<br>Ct | Total<br>%CV | %<br>Agreement<br>with<br>Expected<br>Results | Avg<br>Ct | Total<br>%CV | Agreement<br>with<br>Expected<br>Results | 95% Cl |
| BAA-22 -<br>LP | 100.0%<br>(30/30) | 31.1 | 0.9 | 100.0%<br>(30/30) | 31.1 | 0.7 | 100.0%<br>(30/30) | 29.8 | 0.6 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| BAA-22 -<br>MP | 100.0%<br>(30/30) | 31.0 | 0.4 | 100.0%<br>(30/30) | 30.3 | 0.6 | 100.0%<br>(30/30) | 30.6 | 0.7 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| BAA-<br>1138 -<br>LP | 100.0%<br>(30/30) | 31.0 | 0.8 | 100.0%<br>(30/30) | 31.1 | 0.4 | 100.0%<br>(30/30) | 29.9 | 1.6 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| BAA-<br>1138 -<br>MP | 100.0%<br>(30/30) | 31.0 | 0.7 | 100.0%<br>(30/30) | 31.1 | 0.5 | 100.0%<br>(30/30) | 29.8 | 0.7 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| РС | 100.0%<br>(30/30) | 30.9 | 0.7 | 100.0%<br>(30/30) | 30.2 | 0.4 | 100.0%<br>(30/30) | 30.4 | 0.6 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| NTC | 100.0%<br>(30/30) | 31.0 | 0.5 | 100.0%<br>(30/30) | 31.1 | 0.5 | 100.0%<br>(30/30) | 30.0 | 0.9 | 100.0%<br>(90/90) | 95.9% to<br>100.0% |
| Total<br>Agreement | 100.0% (180/180)<br>95% Cl: 97.9% to 100.0% | | | 100.0% (180/180)<br>95% Cl: 97.9% to 100.0% | | | 100.0% (180/180)<br>95% Cl: 97.9% to 100.0% | | | 100.0% (540/540)<br>95% Cl: 99.3% to<br>100.0% | |
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Image /page/8/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA helix in shades of green and blue on the left. To the right of the helix, the word "DiaSorin" is written in a bold, dark blue font. Below "DiaSorin", the word "Molecular" is written in a lighter green font.
### 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 6 of 19
#### ANALYTICAL SENSITIVITY/LIMIT OF DETECTION
The Limit of Detection (LoD) was determined for the Simplexa™ GBS Direct assay using quantified stocks of two (2) GBS strains (BAA-22 and BAA-1138) serially diluted into negative eighteen to twentyfour (18 to 24) hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. The LoD was determined to be the lowest concentration that could be detected positive ≥ 95% of the time. The results are shown in Table 4.
#### Table 4. Simplexa™ GBS Direct Summary of Limit of Detection (LoD)
| GBS strain | LoD Concentration (CFU/mL) |
|--------------------------------|----------------------------|
| ATCC BAA-22<br>(serotype III) | 80,000 |
| ATCC BAA-1138<br>(serotype la) | 30,000 |
## ANALYTICAL REACTIVITY/CROSS REACTIVITY
#### Analytical Reactivity
The Simplexa™ GBS Direct assay was evaluated for analytical reactivity to an additional eighteen (18) GBS strains spiked at 2 x LoD into eighteen to twenty-four (18 to 24) Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. The results are shown in Table 5. All eighteen (18) strains were detected.
| No. | Group B<br>Streptococcus Strain | Serotype | Concentration<br>CFU/mL<br>(2 x LoD) | SimplexaTM GBS<br>Direct %Detection<br># Detected / # Tested |
|-----|---------------------------------|----------|--------------------------------------|--------------------------------------------------------------|
| 1 | ATCC BAA-1177 | Ia | 110,000 | 100% (3/3) |
| 2 | ATCC 51487 | Ib | 110,000 | 100% (3/3) |
| 3 | ATCC 27591 | Ic | 110,000 | 100% (3/3) |
| 4 | ATCC 12973 | II | 110,000 | 100% (3/3) |
| 5 | ATCC BAA-2675 | II | 110,000 | 100% (3/3) |
| 6 | ATCC BAA-1176 | III | 110,000 | 100% (3/3) |
| 7 | ATCC BAA-2674 | III | 110,000 | 100% (3/3) |
| 8 | ATCC 12403 | III | 110,000 | 100% (3/3) |
| 9 | ATCC 49446 | IV | 110,000 | 100% (3/3) |
| 10 | ATCC BAA-2673 | IV | 110,000 | 100% (3/3) |
| 11 | ATCC BAA-2672 | V | 110,000 | 100% (3/3) |
| 12 | ATCC BAA-611 | V | 110,000 | 100% (3/3) |
| 13 | ATCC BAA-2671 | VI | 110,000 | 100% (3/3) |
| 14 | ATCC BAA-2670 | VII | 110,000 | 100% (3/3) |
| 15 | ATCC BAA-2669 | VIII | 110,000 | 100% (3/3) |
#### Table 5. Simplexa™ GBS Direct Analytical Reactivity
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Image /page/9/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue, with the word "Molecular" underneath in green. The logo is clean and modern, suggesting a focus on biotechnology and molecular diagnostics.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 7 of 19
| No. | Group B<br>Streptococcus Strain | Serotype | Concentration<br>CFU/mL<br>(2 x LoD) | Simplexa™ GBS<br>Direct %Detection<br># Detected / # Tested |
|-----|---------------------------------|---------------|--------------------------------------|-------------------------------------------------------------|
| 16 | ATCC BAA-2668 | IX 1 | 110,000 | 100% (3/3) |
| 17 | ATCC 13813 | Non-Hemolytic | 110,000 | 100% (3/3) |
| 18 | ATCC BAA-2666 | Non-Hemolytic | 110,000 | 100% (3/3) |
#### Cross Reactivity (Analytical Specificity)
The Simplexa™ GBS Direct assay's analytical specificity was evaluated by testing the ability of the assay to exclusively identify GBS without any cross-reactivity to organisms that are closely related, or cause similar clinical symptoms or may be present in eighteen to twenty-four (18 to 24) hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Seventy-four (74) potential cross-reacting organisms were spiked into GBS negative enriched Lim broth and tested in triplicate. Four (4) organisms with low concentration stocks were additionally tested in silico. No cross reactivity was observed demonstrating the specificity of the Simplexa™ GBS Direct assay. The results are presented in Table 7.
| No. | Cross Reactant | Tested Concentration | Expected Negative Results<br>% Detection<br>(# Detected/ # Tested) |
|-----|------------------------------------------|----------------------|--------------------------------------------------------------------|
| 1 | Acinetobacter baumannii | 1 x 106 CFU/mL | 0% (0/3) |
| 2 | Actinomyces israelii | 1 x 106 CFU/mL | 0% (0/3) |
| 3 | Aerococcus viridans | 1 x 106 CFU/mL | 0% (0/3) |
| 4 | Aeromonas hydrophila | 1 x 106 CFU/mL | 0% (0/3) |
| 5 | Atopobium vaginae | 1 x 106 CFU/mL | 0% (0/3) |
| 6 | Bacillus cereus | 1 x 106 CFU/mL | 0% (0/3) |
| 7 | Bacteroides fragilis | 1 x 106 CFU/mL | 0% (0/3) |
| 8 | Bifidobacterium adolescentis | 1 x 106 CFU/mL | 0% (0/3) |
| 9 | Bifidobacterium breve | 1 x 106 CFU/mL | 0% (0/3) |
| 10 | Blastocystis hominis | 1 x 106 cells/mL | 0% (0/3) |
| 11 | Brevibacterium linens | 1 x 106 CFU/mL | 0% (0/3) |
| 12 | Campylobacter jejuni | 1 x 106 CFU/mL | 0% (0/3) |
| 13 | Candida albicans | 1 x 106 CFU/mL | 0% (0/3) |
| 14 | Candida glabrata | 1 x 106 CFU/mL | 0% (0/3) |
| 15 | Candida parapsilosis | 1 x 106 CFU/mL | 0% (0/3) |
| 16 | Candida tropicalis | 1 x 106 CFU/mL | 0% (0/3) |
| 17 | Chlamydia trachomatis | 1 x 106 IFU/mL | 0% (0/3) |
| 18 | Chromobacterium violaceum | 1 x 106 CFU/mL | 0% (0/3) |
| 19 | Clostridium difficile | 1 x 106 CFU/mL | 0% (0/3) |
| 20 | Clostridium perfringens | 1 x 106 CFU/mL | 0% (0/3) |
| No. | Cross Reactant | Tested Concentration | Expected Negative Results<br>% Detection<br>(# Detected/ # Tested) |
| 21 | Corynebacterium genitalium | 1 x 106 CFU/mL | 0% (0/3) |
| 22 | Cryptococcus neoformans | 1 x 106 CFU/mL | 0% (0/3) |
| 23 | Enterobacter cloacae | 1 x 106 CFU/mL | 0% (0/3) |
| 24 | Enterococcus avium | 1 x 106 CFU/mL | 0% (0/3) |
| 25 | Enterococcus faecalis | 1 x 106 CFU/mL | 0% (0/3) |
| 26 | Enterococcus faecium | 1 x 106 CFU/mL | 0% (0/3) |
| 27 | Escherichia coli | 1 x 106 CFU/mL | 0% (0/3) |
| 28 | Fusobacterium nucleatum | 1 x 106 CFU/mL | 0% (0/3) |
| 29 | Gardnerella vaginalis* | NA | NA |
| 30 | Giardia lamblia | 1 x 106 cells/mL | 0% (0/3) |
| 31 | HSV-1 | 1 x 105 TCID50/mL | 0% (0/3) |
| 32 | HSV-2 | 1 x 105 TCID50/mL | 0% (0/3) |
| 33 | HIV-1 | 5 x 104 TCID50/mL * | 0% (0/3) |
| 34 | HPV Genotype 18 | 1 x 105 IU/mL | 0% (0/3) |
| 35 | White Blood Cells (Human genomic<br>DNA) | 1 x 106 cells/mL | 0% (0/3) |
| 36 | Human rotavirus | 1 x 104 TCID50/mL * | 0% (0/3) |
| 37 | Klebsiella oxytoca | 1 x 106 CFU/mL | 0% (0/3) |
| 38 | Klebsiella pneumoniae | 1 x 106 CFU/mL | 0% (0/3) |
| 39 | Lactobacillus acidophilus | 1 x 106 CFU/mL | 0% (0/3) |
| 40 | Lactobacillus crispatus | 1 x 106 CFU/mL | 0% (0/3) |
| 41 | Lactobacillus delbrueckii subsp. lactis | 1 x 106 CFU/mL | 0% (0/3) |
| 42 | Lactobacillus iners | 1 x 106 CFU/mL | 0% (0/3) |
| 43 | Lactobacillus jensensii | 1 x 106 CFU/mL | 0% (0/3) |
| 44 | Mobiluncus curtisii | 1 x 106 CFU/mL | 0% (0/3) |
| 45 | Mobiluncus mulieris | 1 x 106 CFU/mL | 0% (0/3) |
| 46 | Mycoplasma genitalium | 5 x 105 CCU/mL* | 0% (0/5)** |
| 47 | Mycoplasma hominis | 1 x 106 CCU/mL | 0% (0/3) |
| 48 | Norovirus Genogroup GI* | NA | NA |
| 49 | Norovirus Genogroup GII* | NA | NA |
| 50 | Neisseria gonorrhoeae | 1 x 106 CFU/mL | 0% (0/3) |
| 51 | Peptostreptococcus anaerobius | 1 x 106 CFU/mL | 0% (0/3) |
| 52 | Porphyromonas asaccharolytica | 1 x 106 CFU/mL | 0% (0/3) |
| 53 | Prevotella melaninogenica | 1 x 106 CFU/mL | 0% (0/3) |
| No. | Cross Reactant | Tested Concentration | Expected Negative Results<br>% Detection<br>(# Detected/ # Tested) |
| 54 | Propionibacterium acnes | 1 x 106 CFU/mL | 0% (0/3) |
| 55 | Proteus mirabilis | 1 x 106 CFU/mL | 0% (0/3) |
| 56 | Pseudomonas aeruginosa | 1 x 106 CFU/mL | 0% (0/3) |
| 57 | Salmonella enterica subsp enterica | 1 x 106 CFU/mL | 0% (0/3) |
| 58 | Serratia marcescens | 1 x 106 CFU/mL | 0% (0/3) |
| 59 | Shigella sonnei | 1 x 106 CFU/mL | 0% (0/3) |
| 60 | Staphylococcus aureus | 1 x 106 CFU/mL | 0% (0/3) |
| 61 | Staphylococcus epidermidis | 1 x 106 CFU/mL | 0% (0/3) |
| 62 | Staphylococcus saprophyticus | 1 x 106 CFU/mL | 0% (0/3) |
| 63 | Streptococcus anginosus | 1 x 106 CFU/mL | 0% (0/3) |
| 64 | Streptococcus bovis | 1 x 106 CFU/mL | 0% (0/3) |
| 65 | Streptococcus dysgalactiae | 1 x 106 CFU/mL | 0% (0/3) |
| 66 | Streptococcus intermedius | 1 x 106 CFU/mL | 0% (0/3) |
| 67 | Streptococcus mitis | 1 x 106 CFU/mL | 0% (0/3) |
| 68 | Streptococcus oralis | 1 x 106 CFU/mL | 0% (0/3) |
| 69 | Streptococcus pneumoniae | 1 x 106 CFU/mL | 0% (0/3) |
| 70 | Streptococcus pyogenes | 1 x 106 CFU/mL | 0% (0/3) |
| 71 | Streptococcus salivarius | 1 x 106 CFU/mL | 0% (0/3) |
| 72 | Streptococcus sanguinis | 1 x 106 CFU/mL | 0% (0/3) |
| 73 | Streptococcus suis | 1 x 106 CFU/mL | 0% (0/3) |
| 74 | Streptococcus uberis | 1 x 106 CFU/mL | 0% (0/3) |
| 75 | Trichomonas vaginalis* | NA | NA |
| 76 | Ureaplasma urealyticum | 1 x 106 CCU/mL | 0% (0/3) |
| 77 | VZV | 1 x 105 copies/mL | 0% (0/3) |
| 78 | Yersinia enterocolitica | 1 x 106 CFU/mL | 0% (0/3) |
#### Table 7. Simplexa™ GBS Direct Cross Reactivity (Analytical Specificity)
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Image /page/10/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green and blue on the left. To the right of the DNA helix are the words "DiaSorin" in dark blue above the word "Molecular" in light green.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 8 of 19
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for DiaSorin Molecular. The logo features a stylized DNA helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in dark blue on the top line and "Molecular" in green on the bottom line. The text is clean and professional.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 9 of 19
* Tested in silico and no potential for cross-reaction with the Simplexa™ GBS Direct primers and probe observed. ** Tested in quintuplicate due to assay set up error.
NA = not available
#### INTERFERENCE
The performance of the Simplexa™ GBS Direct assay was evaluated with twenty-six (26) potentially interfering endogenous and exogenous substances that may be present in eighteen to twenty-four (18 to 24) hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. All samples were prepared by spiking each potentially interfering substance into a baseline consisting of either the ATCC BAA-1138 or ATCC BAA-22 strain of GBS at a concentration of 2 x LoD in eighteen to twenty-four (18 to 24) hour Lim broth enrichments of vaginal/rectal specimen swabs obtained from antepartum women. Each interferent was spiked into the baseline sample and tested at the concentrations listed in Table 8. The results are presented in Table 8. No interference was observed at the concentrations indicated in Table 8.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image contains the logo for DiaSorin Molecular. The logo features a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in a dark blue, sans-serif font, stacked above the word "Molecular" in a lighter green, sans-serif font.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 10 of 19
| | Potentially Interfering Substance | Active Ingredient | Interferent Concentration |
|----|------------------------------------------------|----------------------------------------------|---------------------------|
| 1 | Amniotic Fluid | NA | 10% v/v |
| 2 | Antacids (Gaviscon) | Aluminum Hydroxide /<br>Magnesium Hydroxide | 5 % v/v* |
| 3 | Antacids/Gastritis Medication | Calcium Carbonate | 10 mg/mL |
| 4 | Anti-Diarrheal Medication<br>(Imodium) | Loperamide Hydrochloride | 10% v/v |
| 5 | Anti-Diarrheal Medication (Pepto<br>Bismol) | Bismuth Subsalicylate | 10% v/v |
| 6 | Anti-Fungal /Anti-Itch Vaginal | Nystatin | 10 mg/mL** |
| 7 | Anti-Hemorrhoid<br>Creams/Ointments | Hydrocortisone | 10 mg/mL |
| 8 | Anti-Hemorrhoid<br>Creams/Ointments | Phenylephrine HCl | 10 mg/mL |
| 9 | Antimicrobials | Clotrimazole | 10% w/v |
| 10 | Fecal Fat | Palmitic Acid | 5 mg/mL* |
| 11 | Gastritis Medications (Nexium) | Esomeprazole Magnesium | 0.31 mg/mL* |
| 12 | Laxatives | Sennosides | 5 mg/mL* |
| 13 | Meconium | NA | 0.31% w/v * |
| 14 | Mesalazine enema | Mesalazine | 5 mg/mL* |
| 15 | Mineral Oil enema | Mineral Oil | 10% v/v |
| 16 | Moist Towelettes | Benzalkonium Chloride | 10% v/v |
| 17 | Moist Towelettes | Ethanol | 10% v/v |
| 18 | Mucus | Immunoglobulin, Lysozyme,<br>Polymers | 10% v/v |
| 19 | Non-Steroidal Anti-Inflammatory<br>Medications | Naproxen Sodium | 3 mg/mL* |
| 20 | Radiology Oral Compounds | Barium Sulfate | 5 mg/mL* |
| 21 | Seminal Fluid | NA | 5% v/v* |
| | Potentially Interfering Substance | Active Ingredient | Interferent Concentration |
| 22 | Spermicidal Lubricant | Nonoxynol-9 | 10 mg/mL |
| 23 | Stool | NA | 0.31% w/v* |
| 24 | Topical Products | Baby Powder | 10 mg/mL |
| 25 | Topical Products | KY Jelly | 10% w/v* |
| 26 | Whole Blood | Glucose, Hormones, Enzymes, Ions, Iron, etc. | 10% v/v |
### Table 8. Simplexa™ GBS Direct Interference
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Image /page/13/Picture/0 description: The image contains the logo for DiaSorin Molecular. The logo consists of a stylized DNA double helix in shades of green and blue on the left. To the right of the helix are the words "DiaSorin" in a bold, dark blue font on the top line, and "Molecular" in a lighter green font on the bottom line.
## 510(k) Summary
Simplexa™ GBS Direct Catalog No. MOL3550 Simplexa™ GBS Positive Control Pack Catalog No. MOL3560 October 25, 2018 Page 11 of 19
False negative and/or Invalid results were obtained at higher concentrations
On initial testing 1 sample produced an EC505 error due to insufficient information to determine whether amplification occurred; the retest result was acceptable
#### INHIBITION BY OTHER MICROORGANISMS
The Simplexa™ GBS Direct assay was evaluated by testing the ability to identify GBS when other potentially inhibitory organisms were present at high concentrations. The panel of seventy-four (74) potentially inhibitory organisms were individually spiked into a pool with a low concentration of GBS BAA-22 or BAA-1138 strains at approximately 2 x LoD in Lim broth enrichments eighteen to twenty-four (18 to 24) hour of vaginal/rectal specimen swabs obtained from antepartum women. No false negative results were observed with GBS BAA-22 in the presence of any of the potentially interfering organisms or viruses. However, with GBS BAA-1138, at least one false negative result was obtained in the presence of each of the following species: Bacillus cereus, Candida parapsilosis, Clostridium perfringens, Peptostreptococcus anaerobius, Staphylococcus saprophyticus, Streptococcus pyogenes and Ureaplasma urealyticum (Table 9). Additional in silico analysis demonstrated no potential for crossreaction or interference with the Simplexa™ GBS Direct primers and probe by Norovirus genogroups I and II or Trichomonas vaginalis.
| No. | Organism | GBS Strain | Tested Concentration | % Detection<br>(# Detected/ # Tested) |
|-----|--------------------------------------------|------------|----------------------|---------------------------------------|
| 1 | Acinetobacter baumannii | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 2 | Actinomyces israelii | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 3 | Aerococcus viridans | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 4 | Aeromonas hydrophila | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| No. | Organism | GBS Strain | Tested Concentration | % Detection<br>(# Detected/ # Tested) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 5 | Atopobium vaginae | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 6 | Bacillus cereus | BAA-1138 | 1 x 106 CFU/mL | 88.9 %(8/9) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 7 | Bacteroides fragilis | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 8 | Bifidobacterium adolescentis | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 9 | Bifidobacterium breve | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 10 | Blastocystis hominis | BAA-1138 | 1 x 106 cells/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 cells/mL | 100% (3/3) |
| 11 | Brevibacterium linens | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 12 | Campylobacter jejuni | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 13 | Candida albicans | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 14 | Candida glabrata | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 15 | Candida parapsilosis | BAA-1138 | 1 x 106 CFU/mL | 77.8% (7/9) |
| No. | Organism | GBS Strain | Tested Concentration | % Detection<br>(# Detected/ # Tested) |
| 16 | Candida tropicalis | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 17 | Chlamydia trachomatis | BAA-1138 | 1 x 106 IFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 IFU/mL | 100% (3/3) |
| 18 | Chromobacterium violaceum | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 19 | Clostridium difficile | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 20 | Clostridium perfringens | BAA-1138 | 1 x 106 CFU/mL | 88.9% (8/9) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 21 | Corynebacterium genitalium | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 22 | Cryptococcus neoformans | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 23 | Enterobacter cloacae | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 24 | Enterococcus avium | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 25 | Enterococcus faecalis | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 26 | Enterococcus faecium | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| No. | Organism | GBS Strain | Tested Concentration | % Detection<br>(# Detected/ # Tested) |
| 27 | Escherichia coli | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| 28 | Fusobacterium nucleatum | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| 29 | Giardia lamblia | BAA-22 | 1 x 106 cells/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 106 cells/mL | 100% (3/3) |
| 30 | HIV-1 | BAA-22 | 5 x 104 TCID50/mL | 100% (3/3) |
| | | BAA-1138 | 5 x 104 TCID50/mL | 100% (3/3) |
| 31 | HPV Genotype 18 | BAA-22 | 1 x 105 IU/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 105 IU/mL | 100% (3/3) |
| 32 | HSV-1 | BAA-22 | 1 x 105 TCID50/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 105 TCID50/mL | 100% (3/3) |
| 33 | HSV-2 | BAA-22 | 1 x 105 TCID50/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 105 TCID50/mL | 100% (3/3) |
| 34 | Human DNA (White Blood<br>Cells) | BAA-22 | 1 x 106 WBC/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 106 WBC/mL | 100% (3/3) |
| 35 | Human rotavirus | BAA-22 | 1 x 104 TCID50/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 104 TCID50/mL | 100% (3/3) |
| 36 | Klebsiella oxytoca | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| No. | Organism | GBS Strain | Tested Concentration | % Detection<br>(# Detected/ # Tested) |
| 37 | Klebsiella pneumoniae | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 38 | Lactobacillus acidophilus | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 39 | Lactobacillus crispatus | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 40 | Lactobacillus delbrueckii<br>subsp. lactis | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 41 | Lactobacillus iners | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 42 | Lactobacillus jensensii | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 43 | Mobiluncus curtisii | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 44 | Mobiluncus mulieris | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| 45 | Mycoplasma genitalium | BAA-1138 | $5 x 10^5$ CCU/mL | 100% (3/3) |
| | | BAA-22 | $5 x 10^5$ CCU/mL | 100% (3/3) |
| 46 | Mycoplasma hominis | BAA-1138 | $1 x 10^6$ CCU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CCU/mL | 100% (3/3) |
| 47 | Neisseria gonorrhoeae | BAA-1138 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| | | BAA-22 | $1 x 10^6$ CFU/mL | 100% (3/3) |
| No. | Organism | GBS Strain | Tested Concentration | % Detection<br>(# Detected/ # Tested) |
| 48 | Norovirus genogroup I* | NA | NA | NA |
| 49 | Norovirus genogroup II* | NA | NA | NA |
| 50 | Peptostreptococcus<br>anaerobius | BAA-1138 | 1 x 106 CFU/mL | 88.9% (8/9) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 51 | Porphyromonas<br>asaccharolytica | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3) |
| | | BAA-22 | 1 x 106 CFU/mL | 100% (3/3) |
| 52 | Prevotella melaninogenica | BAA-1138 | 1 x 106 CFU/mL | 100% (3/3)…
