(72 days)
Not Found
No
The device description mentions "on-board method-specific algorithms" for interpreting fluorescent signals, which is standard for many diagnostic instruments and does not indicate the use of AI or ML. There is no mention of AI, ML, or related concepts like training sets or complex data analysis beyond basic signal processing.
No.
The Solana® GBS Assay is an in vitro diagnostic test for the detection of Group B Streptococcus. It is used to diagnose a condition, not to treat it.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Solana® GBS assay is a qualitative in vitro diagnostic test for detection of Group B Streptococcus".
No
The device description clearly outlines a system that includes physical components like Process Buffer tubes, Reaction Tubes containing lyophilized reagents, and the Solana® Instrument itself, which performs amplification and detection. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states that the Solana® GBS assay is a "qualitative in vitro diagnostic test".
- Device Description: The description details how the device analyzes a biological sample (enriched broth cultures of vaginal/rectal swabs) in vitro (outside of the body) to detect the presence of a specific target (GBS DNA).
- Purpose: The purpose of the test is to aid in the diagnosis of Group B Streptococcus in antepartum women, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The Solana® GBS assay is a qualitative in vitro diagnostic test for detection of Group B Streptococcus in either LIM or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation.
The Solana® GBS Assay utilizes helicase-dependent amplification (HDA) of the Thiolase (atoB) gene sequence. The Solana® GBS Assay is intended for use only with the Solana® Instrument.
The Solana® 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 Solana GBS Assay amplifies and detects GBS DNA isolated from enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation.
The assay consists of two (2) major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to GBS using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.
Patient specimen is transferred to a Process Buffer tube, subjected to heat treatment at 95 ± 2°C for 5 minutes and mixed. The processed sample is transferred to a Reaction Tube and mixed. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the processed sample, the Reaction Tube is placed in Solana for amplification and detection of specific target sequences. In Solana, the GBS target sequence is amplified by GBS specific primers and detected by a GBS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Process Tube to monitor sample processing, for the presence of inhibitory substances in clinical samples, reagent or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe.
The target and PRC probes are labeled with a quencher on one end and a fluorophore (FAM or ROX, respectively) on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GBS or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana will then report the test results to the user on its display screen, and it can print out the results using the attached printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal/rectal swabs
Indicated Patient Age Range
Antepartum women (15 to 44 years old)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Performance characteristics of the Solana GBS Assay were established during a prospective study conducted from July 2017 to September 2017. Seven hundred fifty-three (753) specimens used for this study were collected from antepartum women between 35 to 37 weeks gestation at four distinct geographical sites across the United States. The age range for these women was between 15 to 44 years old. Specimens were inoculated into either LIM or Carrot broth (403 and 350 specimens, respectively) and incubated for 18 to 24 hours at 35°C. Post-incubation specimens were tested by both the Solana GBS Assay and bacterial culture. One (1) specimen (0.2%) was invalid in the Solana GBS Assay when initially tested and upon repeat testing. This specimen has been removed from additional analysis. Table 13 below is for the remaining seven hundred fifty-two (752) specimens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Sensitivity:
Performance characteristics of the Solana GBS Assay were established during a prospective study conducted from July 2017 to September 2017. Seven hundred fifty-three (753) specimens used for this study were collected from antepartum women between 35 to 37 weeks gestation at four distinct geographical sites across the United States. The age range for these women was between 15 to 44 years old. Specimens were inoculated into either LIM or Carrot broth (403 and 350 specimens, respectively) and incubated for 18 to 24 hours at 35°C. Post-incubation specimens were tested by both the Solana GBS Assay and bacterial culture. One (1) specimen (0.2%) was invalid in the Solana GBS Assay when initially tested and upon repeat testing. This specimen has been removed from additional analysis. Table 13 below is for the remaining seven hundred fifty-two (752) specimens.
Table 13. Sensitivity/Specificity of the Solana GBS Assay for GBS Compared to Bacterial Culture
| Broth Type | N | TP | FP | TN | FN | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|---|---|---|---|
| LIM | 402 | 88 | 13 | 301 | O | 100 (95.8 to 100) | 95.9% (93.0 to 97.6) |
| Carrot | 350 | 97 | 10 | 243 | O | 100 (96.2 to 100) | 96.0 (92.9 to 97.8) |
| Combined | 752 | 185 | 23* | 544 | O | 100 (98.0 to 100) | 95.9% (94.0 to 97.3) |
- Nineteen (19) of twenty-three (23) Solana GBS Assay Positive/Bacterial Culture Negative specimens were positive by an additional FDA-cleared molecular test.
Prevalence based on culture = 24.6% (185/752) Prevalence based on Solana® GBS Assay = 27.7% (208/752)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity
LIM: 100% (95.8 to 100)
Carrot: 100% (96.2 to 100)
Combined: 100% (98.0 to 100)
Specificity
LIM: 95.9% (93.0 to 97.6)
Carrot: 96.0% (92.9 to 97.8)
Combined: 95.9% (94.0 to 97.3)
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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December 21, 2017
Quidel Corporation Ronald Lollar Sr. Director, Clinical, Regulatory, Scientific Affairs 2005 East State Street. Suite 100 Athens, Ohio 45701
Re: K173250
Trade/Device Name: Solana GBS Assay Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. serological reagents Regulatory Class: Class I Product Code: NJR Dated: October 5, 2017 Received: October 10, 2017
Dear Ronald Lollar:
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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Ribhi Shawar -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
2
Indications for Use
510(k) Number (if known) K173250
Device Name Solana® GBS Assay
Indications for Use (Describe)
The Solana® GBS assay is a qualitative in vitro diagnostic test for detection of Group B Streptococcus in either LIM or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation. The Solana® GBS Assay utilizes helicase-dependent amplification (HDA) of the Thiolase (atoB) gene sequence. The Solana® GBS Assay is intended for use only with the Solana® Instrument.
The Solana® GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Applicant:
Quidel Corporation 12544 High Bluff Drive, Suite 200 San Diego, California 92130 Telephone: 858-552-7910 Fax: 858-646-8045
Contact Information:
Ronald H. Lollar, Senior Director Clinical and Regulatory Affairs 2005 East State Street, Suite 100 Athens, Ohio 45701 740-589-3300 - Corporate number 740-589-3373 – Desk phone 858-552-6451—Fax Ron.Lollar@quidel.com
Date of preparation of 510(k) summary:
December 04, 2017
A. 510(k) Number:
B. Purpose for Submission:
To obtain substantial equivalence for the Solana® GBS Assay when performed on the Solana " instrument
C. Measurand:
Thiolase (atoB) gene
D. Type of Test:
Helicase-Dependent Amplification (HDA)
4
E. Applicant:
Quidel Corporation
F. Proprietary and Established Names:
Solana GBS Assay
G. Regulatory Information:
| Table 1. | Regulatory Information | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NJR | Class I | 21 CFR 866.3740 Streptococcus | |
| spp. serological reagents | Microbiology | ||
| (83) |
H. Intended Use:
1. Intended Use(s):
The Solana® GBS assay is a qualitative in vitro diagnostic test for detection of Group B Streptococcus in either LIM or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation.
The Solana® GBS Assay utilizes helicase-dependent amplification (HDA) of the Thiolase (atoB) gene sequence. The Solana® GBS Assay is intended for use only with the Solana® Instrument.
The Solana® GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
2. Indication(s) for Use:
Same as Intended Use.
3. Special conditions for use statement(s):
- For in vitro diagnostic use only
- . For prescription use only
5
4. Special instrument requirements:
Solana® Instrument
l. Device Description:
The Solana GBS Assay amplifies and detects GBS DNA isolated from enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation.
The assay consists of two (2) major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to GBS using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.
Patient specimen is transferred to a Process Buffer tube, subjected to heat treatment at 95 ± 2°C for 5 minutes and mixed. The processed sample is transferred to a Reaction Tube and mixed. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the processed sample, the Reaction Tube is placed in Solana for amplification and detection of specific target sequences. In Solana, the GBS target sequence is amplified by GBS specific primers and detected by a GBS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Process Tube to monitor sample processing, for the presence of inhibitory substances in clinical samples, reagent or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe.
The target and PRC probes are labeled with a quencher on one end and a fluorophore (FAM or ROX, respectively) on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GBS or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana will then report the test results to the user on its display screen, and it can print out the results using the attached printer.
6
Materials Provided:
Solana® GBS Assay Kit: M311
48 Tests per kit
| Table 2.
| Kit Components | ||
|---|---|---|
| Component | Quantity | Storage |
| Process Buffer | 48 tubes/kit 1.0 mL | 2°C to 8°C |
| Reaction Tubes | 48 tubes/kit | 2°C to 8°C |
Materials required but not provided:
- External controls for GBS (e.g. Quidel Molecular GBS Control Set, which contains positive and negative controls, serves as an external processing and extraction control)
- Sterile DNase-free filter-blocked positive displacement micropipettor tips
- Micropipettor
- Stopwatch or timer ●
- Scissors or a blade
- Workflow tray ●
- Transfer Rack
- Heat block capable of 95 ± 2°C temperature ●
- . Thermometer
- Solana instrument ●
- Enrichment broth culture (e.g. Lim, Carrot) ●
Substantial Equivalence Information: J.
-
- Predicate device name(s):
AmpliVue® GBS Assay
- Predicate device name(s):
-
- Predicate 510(k) number(s): K133503
7
3. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Table 3. | ||
| Item | Solana® GBS Assay | AmpliVue® GBS Assay (K133503) |
| Intended Use | The Solana® GBS assay is a | |
| qualitative in vitro diagnostic test for | ||
| detection of Group B Streptococcus | ||
| in either LIM or Carrot enrichment | ||
| broth cultures of vaginal/rectal | ||
| swabs from antepartum women | ||
| following 18 to 24 hours of | ||
| incubation. |
The Solana® GBS Assay utilizes
helicase-dependent amplification
(HDA) of the Thiolase (atoB) gene
sequence. The Solana® GBS Assay is
intended for use only with the
Solana® Instrument.
The Solana® GBS Assay does not
provide susceptibility results.
Culture isolates are needed for
performing susceptibility testing as
recommended for penicillin-allergic
women. | The AmpliVue® GBS Assay is a
qualitative in vitro diagnostic test
for the rapid detection of Group B
Streptococcus from vaginal/rectal
swabs from antepartum women
following 18 to 24 hours of
incubation in an LIM enrichment
broth culture. The AmpliVue® GBS
Assay utilizes helicase-dependent
amplification (HDA) of the Thiolase
(atoB) gene sequence and a self-
contained disposable amplification
detection device that allows for
manual evaluation of assay results.
Results can be used as an aid in
determining the colonization status
of antepartum women.
The AmpliVue® GBS Assay does not
provide susceptibility results.
Culture isolates are needed for
performing susceptibility testing as
recommended for penicillin-allergic
women.
The AmpliVue® GBS Assay is
intended for use in hospital,
reference or state laboratory
settings. The device is not intended
for point-of-care use. |
| Sample Types | Enriched broth cultures of
Vaginal/Rectal swab specimens | Same |
| Extraction | Manual | Same |
| DNA Amplification
Technology | Helicase-dependent amplification (HDA) | Same |
| Table 3. | Similarities | |
| Item | Solana® GBS Assay | AmpliVue® GBS Assay (K133503) |
| Target Sequence
Detected | Thiolase (atoB) gene | Same |
8
| Table 4. | Differences | |
|---|---|---|
| Item | Solana® GBS Assay | AmpliVue® GBS Assay (K133503) |
| Sample Type | ||
| Enrichment Culture | LIM Broth, Carrot Broth | Lim Broth |
| Detection | ||
| Technique | Automated | Manual |
| Instrument | Solana | None |
| Testing Time | 38 to 42 minutes | 75 to 90 minutes |
| Clinical Sensitivity | 100% (95%CI: 98.0 - 100%) | 99.5% (95% CI: 96.9-100%) |
| Clinical Specificity | 95.9% (95%CI: 94.0 to 97.3%) | 92.7% (95% CI: 90.5-94.3%) |
K. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceD ocuments/ucm071287.pdf
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006) – http://www.fda.gov/cdrh/oivd/guidance/1588.pdf.
Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceD
ocuments/UCM313794.pdf
L. Test Principle:
The Solana GBS Assay amplifies and detects GBS DNA isolated from enrichment broth cultures of vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation.
9
The assay consists of two (2) major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to GBS using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.
Patient specimen is transferred to a Process Buffer tube, subjected to heat treatment at 95± 2°C for 5 minutes and mixed. The processed sample is transferred to a Reaction Tube and mixed. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the processed sample, the Reaction Tube is placed in Solana for amplification and detection of specific target sequences. In Solana, the GBS target sequence is amplified by GBS specific primers and detected by GBS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Process Tube to monitor sample processing, for the presence of inhibitory substances in clinical samples, reagent or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe.
The target and PRC probes are labeled with a quencher on one end and a fluorophore (FAM or ROX, respectively) on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GBS or PRC amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. Solana measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana will then report the test results to the user on its display screen, and it can print out the results using the attached printer.
M. Performance Characteristics:
-
- Analytical performance:
- a. Precision/Reproducibility:
A four-sample panel consisting of three levels of contrived positive samples and a negative contrived sample were tested in this study. Streptococcus agalactiae strains SS617 or SS618 were diluted in negative Lim broth enriched vaginal/rectal matrix to 3x LOD (2.4x106 CFU/mL and 2.1x106 CFU/mL respectively) for moderate positive, 1x LOD (8.0x105 CFU/mL and 7.1x105 CFU/mL respectively) for low positive and diluted to C20 to C80 for high negative / low positive (8.0x103 CFU/mL and 7.1x103 CFU/mL respectively). Negative matrix without spiked organism was used for the negative sample. The Solana GBS Assay was used per the instructions for use.
Panels and controls were tested at each site by two operators per instrument for five days, each sample tested in three (3) replicates, for a total of 90 results per level (2 operators x 5 days x 3 sites x 3 replicates).
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Solana® GBS Assay 12/04/2017 Page 8 of 16
510(k) Summary
| Table 5.
| Reproducibility Summary | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| SITE | SITE | SITE | |||||||
| Site #1 | Site #2 | Site #3 | Overall Percent | ||||||
| Agreement | 95% | ||||||||
| Confidence | |||||||||
| Interval | |||||||||
| # Expected | |||||||||
| Result/# | |||||||||
| tested | % Agreement | ||||||||
| with Expected | |||||||||
| Result | # Expected | ||||||||
| Result/# | |||||||||
| tested | % Agreement | ||||||||
| with Expected | |||||||||
| Result | # Expected | ||||||||
| Result/# | |||||||||
| tested | % Agreement | ||||||||
| with Expected | |||||||||
| Result | |||||||||
| GBS strain SS617 | |||||||||
| High Negative 1 | |||||||||
| (8.0x103 CFU/mL) | 11/16 | 68.8 | 9/16 | 56.3 | 8/16 | 50.0 | 28/48 | 58.3 | 44.3 to 71.2 |
| GBS strain SS617 | |||||||||
| Low Positive | |||||||||
| (8.0x105 CFU/mL) | 16/16 | 100 | 16/16 | 100 | 16/16 | 100 | 48/48 | 100 | 92.6 to 100 |
| GBS strain SS617 | |||||||||
| Moderate Positive | |||||||||
| (2.4x106 CFU/mL) | 16/16 | 100 | 16/16 | 100 | 16/16 | 100 | 48/48 | 100 | 92.6 to 100 |
| GBS strain SS618 | |||||||||
| High Negative | |||||||||
| (2.63x104 CFU/mL) | 2/14 | 14.3 | 6/14 | 42.9 | 4/14 | 28.6 | 12/42 | 28.6 | 17.2 to 43.6 |
| GBS strain SS618 | |||||||||
| Low Positive | |||||||||
| (7.1x103 CFU/mL) | 14/14 | 100 | 14/14 | 100 | 14/14 | 100 | 42/42 | 100 | 91.6 to 100 |
| GBS strain SS617 | |||||||||
| Moderate Positive | |||||||||
| (2.1x106 CFU/mL) | 14/14 | 100 | 14/14 | 100 | 14/14 | 100 | 42/42 | 100 | 91.6 to 100 |
| Negative Sample | 0/30 | 100 | 0/30 | 100 | 0/30 | 100 | 0/90 | 100 | 95.9 to 100 |
| GBS Positive Control | 30/30 | 100 | 30/30 | 100 | 30/30 | 100 | 90/90 | 100 | 95.9 to 100 |
| GBS Negative Control | 0/30 | 100 | 0/30 | 100 | 0/30 | 100 | 0/90 | 100 | 95.9 to 100 |
1 The Expected Result for High Negative samples was Negative
The results suggest that there are no significant differences between different users and different sites on different days. Reproducibility studies are acceptable.
-
b. Linearity/assay reportable range:
Not applicable – This assay is qualitative. -
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
Not applicable. This assay is qualitative.
Specimen Stability:
11
The stability of vaginal/rectal swab culture matrix prior to addition to Process Buffer was evaluated. Testing was performed with Lim and Carrot broth vaginal/rectal swab culture matrix using one (1) strain of GBS cells at near the LOD target level (strain BAA-611, 1.18 x106 CFU/mL). Enrichment cultures were shown to be stable for up to 48 hours at 20°C to 25°C or 7 days at 2°C to 8°C prior to processing.
Controls:
-
The process control is used to monitor sample processing, to detect HDA ● inhibitory specimens, to confirm the integrity of assay reagents and the operation of the Solana instrument. The process control is included in the Process Buffer tube.
External Controls (Quidel Molecular GBS Control Set), were run on the Solana "GBS Assay each day of testing during the analytical studies. These controls are described as follows: -
. The external positive control may be treated as a patient specimen. The control should be sampled and tested as if it were a patient specimen and processed as described above in the Assay Procedure. The external positive control is intended to monitor substantial reagent and instrument failure.
-
The external negative control may be treated as a patient specimen. The . control should be sampled and tested as if it were a patient specimen and processed as described above in the Assay Procedure. The external negative control is used to detect reagent or environmental contamination (or carryover) by GBS DNA or amplicon.
-
. It is recommended that the reactivity of each new lot and each new shipment of the Solana GBS Assay be verified on receipt and before use. External control tests should be performed thereafter in accordance with appropriate federal, state and local guidelines. The Solana GBS assay should not be used in patient testing if the external controls do not produce the correct results.
d. Detection limit:
The analytical sensitivity (limit of detection or LOD) of the Solana GBS assay was determined using genomic GBS DNA and quantified (CFU/mL) cultures of six Streptococcus aqalactiae strains (ATCC BAA-611, SS617, SS618, SS619, ATCC 12403, and SS700) serially diluted in a negative LIM Broth enriched vaginal/rectal matrix.
12
6.3x103
6.3x103
510(k) Summary
| Table 6. LOD Results | ||||
|---|---|---|---|---|
| Target Type | Strain Name | Determined LOD | ||
| Copies/Assay | CFU/mL | CFU/Assay | ||
| GBS Genomic DNA | 16.67 | |||
| GBS Cells | ATCC BAA-611 | 5.9x105 | 1.4x103 | |
| SS617 | 8.0x105 | 1.9x103 | ||
| Freshly Grown | SS618 | 7.1x105 | ||
| SS619 | 7.6x105 | |||
| ATCC 12403 | 2.6x106 | |||
| SS700 | 4.9x105 |
ATCC 12403
ATCC 12403
The LOD of the Solana GBS assay was furthered confirmed using frozen GBS cells in Negative Carrot Broth enriched vaginal/rectal matrix.
e. Analytical specificity:
Frozen
Carrot Broth
Cross Reactivity:
A study was performed to determine if ninety-seven (97) microorganisms or viruses (eighty-two (82) bacteria, three yeast (3), eleven (11) viruses and a parasite (1)) potentially found in vaginal/rectal samples cross-react with the Solana® GBS Assay. The same ninety-seven (97) microorganisms were used to determine if they interfered with one GBS strain (ATCC 12403) at 2x LOD (5.2x106 CFU/mL) in the Solana® GBS Assay The potentially cross-reactive or interfering microorganisms were tested at or above clinically relevant levels (bacteria ≥ 1 x 106 CFU/mL, viruses the ≥ 1 x 105TCID50/mL).
2.6x106
2.6x106
Human genomic DNA was also evaluated for cross-reactivity and interference.
| Aeromonas hydrophila (2 strains) | Enterococcus faecalis | Salmonella enterica enterica
Serovar Typhimurium |
|----------------------------------|-----------------------|-----------------------------------------------------|
| Abiotrophia defectiva | Enterococcus faecium | Salmonella enterica indica |
13
| Table 7. Bacteria | ||
|---|---|---|
| Acinetobacter baumanii | Escherichia coli | Serratia liquefaciens |
| Alcaligenes faecalis | ||
| faecalis | Escherichia fergusonii | Serratia marcescens |
| Bacillus cereus | Gardnerella vaginalis | Shigella boydii |
| Bacillus subtilis (2 strains) | Group C Strep | Shigella flexneri |
| Bacteroides fragilis (2 strains) | Helicobacter pylori | Shigella sonnei |
| Bifidobacterium | ||
| adolescentis (2 strains) | Klebsiella oxytoca | Staphylococcus aureus |
| Campylobacter fetus | Klebsiella pneumoniae | Staphylococcus epidermidis |
| Campylobacter | ||
| hyointestinalis | Lactobacillus acidophilus | Stenotrophomonas |
| maltophilia | ||
| Campylobacter jejuni (2 strains) | Legionella pneumophila | Streptococcus mutans |
| Chlamydia trachomatis 1 | Listeria monocytogenes | Streptococcus pyogenes |
| Citrobacter freundii | Mobiluncus mulieris | Streptococcus bovis |
| Clostridium bifermentans | Moraxella cartarrhalis | Streptococcus dysgalactiae |
| Clostridium butyricum | Morganella morganii | Streptococcus gordonii |
| Clostridium difficile | Neisseria gonorrhoeae | Streptococcus intermedius |
| Clostridium haemolyticum | Peptostreptococcus | |
| anaerobius | Streptococcus mitis | |
| Clostridium novyi | Pleisiomonas shigelloides | Streptococcus oralis |
| Clostridium orbiscindens | Porphyromonas | |
| asaccharolytica | Streptococcus pneumoniae | |
| Clostridium perfringens | Prevotella melaninogenica | Streptococcus salivarius |
| Clostridium septicum | Proteus mirabilus | Streptococcus suis |
| Clostridium sordellii | Providencia alcalifaciens | Streptococcus uberis |
| Clostridium sporogenes | Pseudomonas aeruginosa | Ureaplasma urealyticum |
| Edwardsiella tarda | Pseudomonas fluorescens | Vibrio parahaemolyticus |
| Enterobacter aerogenes | Salmonella choleraesius | |
| (typhimurium) | Yersinia enterocolitica | |
| Enterobacter cloacae | Salmonella enterica arizonae |
1 Tested at 106 Inclusion Forming Units/mL
| Table 8. | Yeast | |
|---|---|---|
| Candida albicans | Candida glabrata | Candida parapsilosis |
14
| Table 9. | Viruses | |||
|---|---|---|---|---|
| Adenovirus | Enterovirus | Norovirus | ||
| CMV | HPV-16 1 | Rotavirus | ||
| Coxsackie virus | HSV1 (Macintyre) | VZV | ||
| Echovirus | HSV2 (G) |
1 Tested using a transformed cell line at 1 x 105 copies/mL
| Table 10. | Parasite |
|---|---|
| Trichomonas vaginalis 1 |
1 Tested at 106 trichomonads/mL
None of the organisms or viruses tested above cross-reacted or interfered with the performance of the Solana GBS Assay.
Human genomic DNA did not cross-react or interfere with the performance of the Solana GBS Assay.
Interference:
The performance of Solana GBS Assay was evaluated with thirty-four (34) potentially interfering substances that may be present in vaginal/rectal specimens. The substances were tested in GBS negative Lim broth enriched vaginal/rectal matrix in the presence or absence of GBS cells (strain ATCC 12403) at 2x LOD (5.2x106 CFU/mL) in the Solana GBS Assay.
| Table 11. Interfering Substances | |||
|---|---|---|---|
| Substance Name | Test Concentration in Contrived Sample | Substance Name | Test Concentration in Contrived Sample |
| Cortizone 10 (Hydrocortisone) | 0.1% Swab Amount/µL | Hemoglobin | 64 µg/mL |
| Desitin (Zinc Oxide) | 0.1% Swab Amount/µL | Prilosec (Esomeprazole Magnesium Hydrate) | 10 µg/mL |
| Urine | 2% (v/v) | Fecal Fat- Stearic Acid | 520 µg/mL |
| Table 11. Interfering Substances | |||
| Substance Name | Test Concentration in Contrived Sample | Substance Name | Test Concentration in Contrived Sample |
| Preparation H (Phenylephrine) | 0.04% (w/v) | Tagamet (Cimetidine) | 10 µg/mL |
| Tums (Calcium Carbonate) | 10 µg/mL | Miconazole Nitrate Salt | 0.04% (w/v) |
| Mylanta (Al(OH)3, MG(OH)3) | 2 µg/ml | Nystatin | 200 USP U/ml |
| Fleet Mineral Oil Enema | 0.2% (v/v) | Fecal Sugar- Dextrose | 20 µg/mL |
| Gynol II Vaginal Contraceptive (Nonoxynol-9) | 0.1% Swab Amount/µL | Human Serum Albumin | 200 µg/mL |
| Imodium AD (Loperamide HCl) | 20 µg/ml | Triclosan | 0.002% w/v |
| Pepto Bismol (Bismuth subsalicylate) | 17 µg/ml | Hemorrhoidal cream (Target Brand Cream) | 0.1% Swab Amount/µL |
| Tucks personal cleaning pads (Witch hazel) | 2% (v/v) | KY Jelly | 0.1% Swab Amount/µL |
| Benzalkonium Chloride Towelettes | 0.0024% (v/v) | Petroleum Jelly | 0.1% Swab Amount/µL |
| Ethanol | 0.2% (v/v) | Body Powder | 0.1% Swab Amount/µL |
| Whole Blood | 2% (v/v) | Meconium | 0.1% Swab Amount/µL |
| Fecal Fat- Palmitic acid | 26 µg/mL | Baby Powder | 0.1% Swab Amount/µL |
| Mucin | 60 µg/mL | Amniotic Fluid | 2% (v/v) |
| Barium Sulfate | 100 µg/mL | Stool | 0.1% Swab Amount/µL |
15
No false positive results or interference was seen with any of the thirty-four (34) potentially interfering substances that were tested.
Analytical Reactivity (Inclusivity):
The reactivity of the Solana GBS Assay was evaluated against an additional fourteen (14) strains of Streptococcus agalactiae with different serotypes or that were not typed, in
16
addition to GBS strains BAA-611, SS617, SS618, SS619, ATCC 12403, and SS700 used in the LOD study. The testing was performed at 1X LOD (2.6×10° CFU/mL) level of the assay. All additional fourteen (14) strains were detected in the Solana GBS Assay. The serotypes of these GBS strains are listed in the table below:
| Table 12. GBS Strains at 1x LOD (2.6x106 CFU/mL) | |
|---|---|
| GBS Strain | Serotype |
| ATCC 12973 | II |
| CCUG 28551 | IV |
| CCUG 29785 | VI |
| CNCTC 6609 | VII |
| BAA-2669 | VIII |
| BAA-2668 | IX |
| ATCC 49449 | X |
| ATCC 27956 | Not typed |
| ATCC 7077 | Not typed |
| ATCC 4768 | Not typed |
| ATCC 12927 | Not typed |
| ATCC 9925 | Not typed |
| ATCC 55194 | Not typed |
| ATCC 55191 | Not typed |
-
f. Assay cut-off:
Not applicable. -
- Comparison studies:
- a. Method comparison with predicate device:
Not applicable
-
b. Matrix comparison:
Not applicable -
- Clinical studies:
- a. Clinical Sensitivity:
17
Performance characteristics of the Solana GBS Assay were established during a prospective study conducted from July 2017 to September 2017. Seven hundred fifty-three (753) specimens used for this study were collected from antepartum women between 35 to 37 weeks gestation at four distinct geographical sites across the United States. The age range for these women was between 15 to 44 years old. Specimens were inoculated into either LIM or Carrot broth (403 and 350 specimens, respectively) and incubated for 18 to 24 hours at 35°C. Post-incubation specimens were tested by both the Solana GBS Assay and bacterial culture. One (1) specimen (0.2%) was invalid in the Solana GBS Assay when initially tested and upon repeat testing. This specimen has been removed from additional analysis. Table 13 below is for the remaining seven hundred fifty-two (752) specimens.
| | Sensitivity/Specificity of the Solana GBS Assay for GBS Compared to Bacterial
Table 13. | | | | | | |
|------------|--------------------------------------------------------------------------------------------|-----|-----|-----|----|-------------------------|---------------------------|
| Culture | | | | | | | |
| Broth Type | N | TP | FP | TN | FN | Sensitivity
(95% CI) | Specificity
(95% CI) |
| LIM | 402 | 88 | 13 | 301 | O | 100
(95.8 to 100) | ਰੇਟ 'ਰੇ
(93.0 to 97.6) |
| Carrot | 350 | 97 | 10 | 243 | O | 100
(96.2 to 100) | 96.0
(92.9 to 97.8) |
| Combined | 752 | 185 | 23* | 544 | O | 100
(98.0 to 100) | ਰੇਟ 'ਚੇ
(94.0 to 97.3) |
- Nineteen (19) of twenty-three (23) Solana GBS Assay Positive/Bacterial Culture Negative specimens were positive by an additional FDA-cleared molecular test.
Prevalence based on culture = 24.6% (185/752) Prevalence based on Solana® GBS Assay = 27.7% (208/752)
-
b. Clinical specificity:
See Section 3a. -
Other clinical supportive data (when a. and b. are not applicable): C.
Not applicable -
- Clinical cut-off:
Not applicable
- Clinical cut-off:
18
5. Expected values:
Clinical performance of the Solana GBS assay with Lim and Carrot enrichment broths was established during a prospective study conducted from July 2017 to September 2017. Seven hundred fifty-three (753) specimens collected from antepartum women between 35 to 37 weeks' gestation at four distinct geographical sites across the United States, were tested. One (1) specimen (0.2%) was invalid in the Solana GBS Assay when initially tested and upon repeat testing. This specimen has been removed from additional analysis. The age range for these women was between 15 to 44 years old. The percentage of positive cases as determined by the Solana GBS assay during the study was 27.7% (208/752).
N. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Instrument: Solana Instrument
O. System Descriptions:
2. Software:
FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:
Yes X No ___________________________________________________________________________________________________________________________________________________________________________
P. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10 and 21 CFR 801.109.
Q. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.