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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Solana GBS Assay, based on the provided text:

Acceptance Criteria and Device Performance

The provided document defines the analytical and clinical performance characteristics of the Solana GBS Assay. While explicit "acceptance criteria" are not presented as a direct table of pass/fail thresholds before the study, the "Comparison with predicate" section (Table 4) and the "Clinical studies" section (Table 13) present the performance of the predicate device and the new device, respectively. The implication is that the new device's performance needs to be comparable or superior to the predicate for substantial equivalence.

Here's a table summarizing the reported device performance, with the predicate performance included for comparison where available:

Table: Acceptance Criteria (Implied) and Reported Device Performance

Performance Characteristic	Predicate Device (AmpliVue® GBS Assay) Performance	Solana® GBS Assay Reported Performance
Clinical Sensitivity	99.5% (95% CI: 96.9-100%)	100% (95% CI: 98.0-100%)
Clinical Specificity	92.7% (95% CI: 90.5-94.3%)	95.9% (95% CI: 94.0-97.3%)
LOD (GBS Cells)	Not explicitly stated	Ranges from 4.9x10^5 to 2.6x10^6 CFU/mL across strains (see Table 6 for details)
Reproducibility (Overall)	Not explicitly stated	100% agreement for low and moderate positives, 100% for negative and controls. High Negative ranges from 28.6% to 58.3% agreement.
Test Time	75 to 90 minutes	38 to 42 minutes

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 753 specimens were collected for the clinical study. One specimen was invalid, resulting in 752 specimens analyzed.
  - 403 specimens used LIM broth.
  - 350 specimens used Carrot broth.
- Data Provenance: Prospective study. Specimens were collected from four distinct geographical sites across the United States.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document states that specimens were tested by "bacterial culture" to establish ground truth.
- The specific number of experts and their qualifications (e.g., radiologist with 10 years of experience) are not specified in the provided text. The ground truth for this in vitro diagnostic device is standard laboratory bacterial culture, which is typically considered the gold standard for GBS detection. Expert adjudication as would be seen in an imaging study is not applicable here.
Adjudication Method for the Test Set:
- Not applicable in the context of this in vitro diagnostic bacterial culture-based study. The ground truth was established by bacterial culture. For samples where the Solana GBS Assay was positive but bacterial culture was negative (False Positives), these were further tested by "an additional FDA-cleared molecular test" (19 of 23 instances were confirmed positive by this molecular test). This serves as a form of adjudication or further investigation for discordant results.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic tools that involve human interpretation (e.g., radiologists reading images with AI-aid). The Solana GBS Assay is an automated in vitro diagnostic device, not an AI assistance tool for human readers.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the primary performance evaluation (clinical study) is a standalone performance assessment of the Solana GBS Assay compared to bacterial culture. The device "measures and interprets the fluorescent signal, using on-board method-specific algorithms" and "then reports the test results to the user on its display screen." There is no human interpretation component in the device's determination of positive/negative results.
The Type of Ground Truth Used:
- Bacterial Culture was used as the primary ground truth for clinical sensitivity and specificity.
- For discordant results (Solana Positive/Culture Negative), an additional FDA-cleared molecular test was used to further confirm positive status.
The Sample Size for the Training Set:
- The document does not explicitly state the sample size used for the training set. The performance characteristics listed (LOD, reproducibility, analytical specificity, clinical performance) are derived from the validation studies of the device. For in vitro diagnostic molecular assays like this, the "training" (development) of the assay's parameters (e.g., primer design, probe chemistry, HDA conditions, detection algorithms) is an internal process, but the specific datasets used for that initial development are not typically disclosed in a 510(k) summary for these types of devices. The clinical and analytical studies described serve as the test set for regulatory submission.
How the Ground Truth for the Training Set was Established:
- As the training set size is not explicitly mentioned, the method for establishing its ground truth is also not described in the document. However, for developing such assays, ground truth for training would typically involve well-characterized bacterial cultures (known positive and negative strains at various concentrations) and potentially clinical samples with established culture results, similar to how the ground truth for the validation test set was established.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K173250

Device Name Solana® GBS Assay

Indications for Use (Describe)

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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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:

K173250

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)

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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 Streptococcusspp. serological reagents	Microbiology(83)

H. Intended Use:

1. Intended Use(s):

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

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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.

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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.

1. Predicate device name(s):
  AmpliVue® GBS Assay
1. Predicate 510(k) number(s): K133503

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3. Comparison with predicate:

Similarities
Table 3.
Item	Solana® GBS Assay	AmpliVue® GBS Assay (K133503)
Intended Use	The Solana® GBS assay is aqualitative in vitro diagnostic test fordetection of Group B Streptococcusin either LIM or Carrot enrichmentbroth cultures of vaginal/rectalswabs from antepartum womenfollowing 18 to 24 hours ofincubation.The Solana® GBS Assay utilizeshelicase-dependent amplification(HDA) of the Thiolase (atoB) genesequence. The Solana® GBS Assay isintended for use only with theSolana® Instrument.The Solana® GBS Assay does notprovide susceptibility results.Culture isolates are needed forperforming susceptibility testing asrecommended for penicillin-allergicwomen.	The AmpliVue® GBS Assay is aqualitative in vitro diagnostic testfor the rapid detection of Group BStreptococcus from vaginal/rectalswabs from antepartum womenfollowing 18 to 24 hours ofincubation in an LIM enrichmentbroth culture. The AmpliVue® GBSAssay utilizes helicase-dependentamplification (HDA) of the Thiolase(atoB) gene sequence and a self-contained disposable amplificationdetection device that allows formanual evaluation of assay results.Results can be used as an aid indetermining the colonization statusof antepartum women.The AmpliVue® GBS Assay does notprovide susceptibility results.Culture isolates are needed forperforming susceptibility testing asrecommended for penicillin-allergicwomen.The AmpliVue® GBS Assay isintended for use in hospital,reference or state laboratorysettings. The device is not intendedfor point-of-care use.
Sample Types	Enriched broth cultures ofVaginal/Rectal swab specimens	Same
Extraction	Manual	Same
DNA AmplificationTechnology	Helicase-dependent amplification (HDA)	Same
Table 3.	Similarities
Item	Solana® GBS Assay	AmpliVue® GBS Assay (K133503)
Target SequenceDetected	Thiolase (atoB) gene	Same

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Table 4.	Differences
Item	Solana® GBS Assay	AmpliVue® GBS Assay (K133503)
Sample TypeEnrichment Culture	LIM Broth, Carrot Broth	Lim Broth
DetectionTechnique	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.

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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.

M. Performance Characteristics:

1. 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 PercentAgreement	95%ConfidenceInterval
	# ExpectedResult/#tested	% Agreementwith ExpectedResult	# ExpectedResult/#tested	% Agreementwith ExpectedResult	# ExpectedResult/#tested	% Agreementwith ExpectedResult
GBS strain SS617High 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 SS617Low Positive(8.0x105 CFU/mL)	16/16	100	16/16	100	16/16	100	48/48	100	92.6 to 100
GBS strain SS617Moderate Positive(2.4x106 CFU/mL)	16/16	100	16/16	100	16/16	100	48/48	100	92.6 to 100
GBS strain SS618High 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 SS618Low Positive(7.1x103 CFU/mL)	14/14	100	14/14	100	14/14	100	42/42	100	91.6 to 100
GBS strain SS617Moderate 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:

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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.

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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

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

Human genomic DNA was also evaluated for cross-reactivity and interference.

Aeromonas hydrophila (2 strains)	Enterococcus faecalis	Salmonella enterica entericaSerovar Typhimurium
Abiotrophia defectiva	Enterococcus faecium	Salmonella enterica indica

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Table 7. Bacteria
Acinetobacter baumanii	Escherichia coli	Serratia liquefaciens
Alcaligenes faecalisfaecalis	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
Bifidobacteriumadolescentis (2 strains)	Klebsiella oxytoca	Staphylococcus aureus
Campylobacter fetus	Klebsiella pneumoniae	Staphylococcus epidermidis
Campylobacterhyointestinalis	Lactobacillus acidophilus	Stenotrophomonasmaltophilia
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	Peptostreptococcusanaerobius	Streptococcus mitis
Clostridium novyi	Pleisiomonas shigelloides	Streptococcus oralis
Clostridium orbiscindens	Porphyromonasasaccharolytica	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

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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

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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.
1. Comparison studies:
- a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:
Not applicable
1. Clinical studies:
- a. Clinical Sensitivity:

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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 BacterialTable 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
1. Clinical cut-off:
  Not applicable

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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.

Regulation Number and Section

§ 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.