← Product Code [OZZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/OZZ) · K181029

# Solana Bordetella Complete Assay (K181029)

_Quidel Corporation · OZZ · Jul 15, 2018 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZZ/K181029

## Device Facts

- **Applicant:** Quidel Corporation
- **Product Code:** [OZZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/OZZ.md)
- **Decision Date:** Jul 15, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3980
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** Pediatric

## Indications for Use

The Solana Bordetella Complete Assay is an in vitro diagnostic test for the qualitative detection of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to Bordetella pertussis and Bordetella parapertussis. The Solana Bordetella Complete Assay is an HDA-based duplex assay that targets the IS481 and IS1001 sequence of Bordetella pertussis (BP) and Bordetella parapertussis (BPP) genomes, respectively. The IS481 sequence may also be found in strains of other organisms (i.e., B. holmesii and B. bronchiseptica). The IS1001 sequence may also be found in strains of other organisms (i.e., B. bronchiseptica). B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the Solana Bordetella Complete Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Solana Bordetella Complete Assay should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of B. pertussis and or B. parapertussis infection and should not be used as the sole basis for treatment or other patient management decisions.

## Device Story

The Solana Bordetella Complete Assay detects B. pertussis and B. parapertussis DNA from nasopharyngeal swabs. The process involves: 1) specimen heat lysis (95°C for 5 minutes) in a Process Buffer Tube; 2) isothermal Helicase-Dependent Amplification (HDA) in a Reaction Tube containing lyophilized reagents, dNTPs, primers, and fluorescence probes. The Solana instrument performs amplification and detection. Probes are cleaved by RNaseH2 upon annealing to target amplicons, increasing fluorescence. A process control (PRC) monitors inhibition and reagent/instrument failure. The instrument interprets fluorescent signals via on-board algorithms and displays results. Used in clinical settings by healthcare professionals to aid in diagnosing respiratory infections; results must be interpreted alongside clinical evaluation.

## Clinical Evidence

Prospective study (n=737) and retrospective study (n=233) compared Solana assay to composite reference method (PCR + sequencing). Prospective: B. pertussis PPA 100%, NPA 99.6%; B. parapertussis PPA 100%, NPA 100%. Retrospective: B. pertussis PPA 98.1%, NPA 92.0%; B. parapertussis PPA 100%, NPA 98.6%.

## Technological Characteristics

Isothermal Helicase-Dependent Amplification (HDA). Targets: IS481 (B. pertussis) and IS1001 (B. parapertussis). Fluorescence-based detection using RNaseH2 cleavage of probes. Standalone instrument (Solana). Qualitative output.

## Regulatory Identification

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.

## Special Controls

*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

## Predicate Devices

- ARIES Bordetella Assay ([K163626](/device/K163626.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K181029

B. Purpose for Submission:
Clearance of the Solana Bordetella Complete Assay on the Solana instrument

C. Measurand:
Bordetella pertussis: IS481 Insertional Element sequence;
Bordetella parapertussis: IS1001 Insertional Element sequence

D. Type of Test:
Helicase-Dependent Amplification (HDA)

E. Applicant:
Quidel Corporation

F. Proprietary and Established Names:
Solana Bordetella Complete Assay

G. Regulatory Information:
1. Regulation section:
866.3980
Respiratory viral panel multiplex nucleic acid assay
2. Classification:
Class II
3. Product code:
OZZ

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4. Panel:

Microbiology (83)

H. Intended Use:

1. Intended use(s):

The Solana Bordetella Complete Assay is an in vitro diagnostic test for the qualitative detection of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to Bordetella pertussis and Bordetella parapertussis.

The Solana Bordetella Complete Assay is an HDA-based duplex assay that targets the IS481 and IS1001 sequence of Bordetella pertussis (BP) and Bordetella parapertussis (BPP) genomes, respectively. The IS481 sequence may also be found in strains of other organisms (i.e., B. holmesii and B. bronchiseptica). The IS1001 sequence may also be found in strains of other organisms (i.e., B. bronchiseptica). B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results for the Solana Bordetella Complete Assay do not preclude B. pertussis or B. parapertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the Solana Bordetella Complete Assay should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of B. pertussis and or B. parapertussis infection and should not be used as the sole basis for treatment or other patient management decisions.

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

4. Special instrument requirements:

Solana Instrument

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I. Device Description:

The Solana Bordetella Complete Assay amplifies, detects and differentiates DNA of Bordetella pertussis and Bordetella parapertussis from nasopharyngeal swabs.

The assay consists of two major steps: 1) specimen preparation, and 2) amplification and detection of target sequences specific to B. pertussis and B. parapertussis using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probes.

A patient nasopharyngeal swab specimen in transport media is transferred to a Process Buffer Tube, subjected to heat treatment at 95°C for 5 minutes and mixed. The processed sample is transferred to a Reaction Tube. 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 B. pertussis and B. parapertussis-specific target sequences. In Solana, the target sequences are amplified by B. pertussis and B. parapertussis specific primers and detected by B. pertussis and B. parapertussis-specific fluorescence probes, respectively. A process control (PRC) is included in the Process Buffer Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe.

The two target probes and PRC probe are labeled with a quencher on one end and a fluorophore on the other end. In addition, the two target probes and PRC probe have one or more bases that are comprised of ribonucleic acid. Upon annealing to B. pertussis and B. parapertussis 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 then reports the test results to the user on its display screen, and it can print out the results via an attached printer.

Materials Provided:

Solana Bordetella Complete Assay Kit: M308, 48 Tests per kit

|  Kit Components  |   |   |
| --- | --- | --- |
|  Component | Quantity | Storage  |
|  Process Buffer | 48 tubes/kit, 1.45 mL | 2°C to 8°C  |
|  Reaction Tubes | 48 tubes/kit | 2°C to 8°C  |

Materials required but not provided:

- External controls for B. pertussis and B. parapertussis (e.g. Quidel Molecular Bordetella Control Set, Cat. No. M117 which contains positive and negative controls, serves as an external processing control)
- Sterile DNase-free filter-blocked positive displacement micropipettor tips

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- Micropipettor
- Stopwatch or timer
- Scissors or a blade
- Workflow tray
- Transfer Rack
- Heat block capable of 95° ± 2°C temperature
- Thermometer
- Solana instrument

## J. Substantial Equivalence Information:

1. Predicate device name(s):

ARIES Bordetella Assay

2. Predicate 510(k) number(s):

K163626

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Solana Bordetella Complete Assay (K181029) | ARIES Bordetella Assay (K163626)  |
|  Intended Use | An assay for the qualitative detection of Bordetella pertussis and Bordetella parapertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.
When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.
Negative results for the Solana Bordetella Complete Assay do not preclude B. pertussis or | An assay for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.
When clinical factors suggest that B. pertussis or B. parapertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.
Negative results for the ARIES  |

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|  Differences  |   |   |
| --- | --- | --- |
|  Item | Solana Bordetella Complete Assay | ARIES Bordetella Assay (k163626)  |
|  Target | Bordetella pertussis: IS481 Insertional Element sequence; Bordetella parapertussis: IS1001 Insertional Element sequence | Bordetella pertussis: Toxin promoter (ptxA-pr); Bordetella parapertussis: IS1001 sequence  |
|  Amplification Technology | Helicase-Dependent Amplification (HDA) | Real Time PCR  |
|  Detection Techniques | Different fluorescent reporter dyes for each target. Fluorescence Emissions and Detection | Different fluorescent reporter dyes for each target and melt analysis. Fluorescence Emissions and Detection  |
|  Extraction Methods | None | Automated by the ARIES Systems  |
|  Instrument | Solana | ARIES Systems  |

# K. Standard/Guidance Document Referenced (if applicable):

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay

Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (Final, 3/13/2007)

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Leftover Human Specimens that are Not Individually Identifiable (April 2006)

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Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device (December 2012)

L. Test Principle:

The assay consists of two major steps: 1) specimen preparation, and 2) amplification and detection of target sequences specific to *B. pertussis* and *B. parapertussis* using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probes.

A patient nasopharyngeal swab specimen in transport media is transferred to a Process Buffer Tube, subjected to heat treatment at $95^{\circ} \pm 2^{\circ}\mathrm{C}$ for 5 minutes and mixed. The processed sample is transferred to a Reaction Tube. 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 *B. pertussis* and *B. parapertussis*-specific target sequences. In Solana, the target sequences are amplified by *B. pertussis* and *B. parapertussis* specific primers and detected by *B. pertussis* and *B. parapertussis*-specific fluorescence probes, respectively. A process control (PRC) is included in the Process Buffer Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by specific primers and detected by a PRC specific fluorescence probe.

The two target probes and PRC probe are labeled with a quencher on one end and a fluorophore on the other end. In addition, the two target probes and PRC probe have one or more bases that are comprised of ribonucleic acid. Upon annealing to *B. pertussis* and *B. parapertussis* 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 then reports the test results to the user on its display screen, and it can print out the results via an attached printer.

M. Performance Characteristics:

1. Analytical Performance:

a. Precision/Reproducibility

A repeatability study was conducted using a panel of 30 contrived samples with two (2) subsets of 15 samples, where operator 1 tested samples 1-15 and operator 2 tested samples 16-30. Each subset was manufactured as negative samples (n=3), high negative samples containing BP and BPP (n=3; C₂₀ – C₈₀ concentration per target), low positive samples containing BP or BPP (n=3; near the assay limit of detection), and moderate positive samples containing BP and BPP (n=3; 2x LoD per target) (see Table below). The positive samples were generated from two (2) separate strains each of BP and BPP in equal proportions. The samples were randomized and blind-coded within each panel, and each operator tested one (1)

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panel subset, along with three (3) positive and three (3) negative external controls, in two (2) runs.

Panels and controls were tested at one (1) site by two (2) operators per instrument for fifteen (15) days, each sample tested in three (3) replicates, for a total of 45 results per level for each organism strain (2 operators x 15 days x 3 replicates). The following table (Table 1) describes the repeatability test panel subset composition, and the corresponding expected results.

|  Table 1. Repeatability Panel Subset Composition  |   |   |   |
| --- | --- | --- | --- |
|  Panel Members | # of Samples | BP or BPP Concentrations | Expected Results  |
|  Negative | 3 | 0 | Negative: 100%  |
|  BP+BPP High Negative | 3 | C20 – C80 per target BP A639 (103 CFU/mL) BP E431 (86 CFU/mL) BPP A747 (462 CFU/mL) BPP E838 (553 CFU/mL) | BP Positive: 20-80%; BPP Positive: 20-80%;  |
|  BP Low Positive | 3 | 1X LoD BP A639 (1025 CFU/mL) BP E431 (862 CFU/mL) | BP Positive: ≥ 95%  |
|  BPP Low Positive | 3 | 1X LoD BPP A747 (4622 CFU/mL) BPP E838 (5533 CFU/mL) | BPP Positive: ≥ 95%  |
|  BP+BPP Moderate Positive | 3 | 2X LoD per target BP A639 (2050 CFU/mL) BP E431 (1724 CFU/mL) BPP A747 (9244 CFU/mL)BPP E838 (11,066 CFU/mL) | BP Positive: 100%; BPP Positive: 100%  |

Negative nasal matrix without spiked organism was used for the negative sample. Positive and negative controls were run in triplicate along with the panels. The panels were run by four (4) operators for fifteen (15) non-consecutive days.

A summary of the repeatability testing is as follows:

|  Table 2. Repeatability Testing Summary Results-B. pertussis  |   |   |   |
| --- | --- | --- | --- |
|  Bordetella pertussis | # Detected  |   |   |
|   |  Moderate Positive | Low Positive | High Negative  |
|  BP A639 | 45 | 45 | 28  |
|  BP E431 | 45 | 45 | 27  |
|  % Detected | 90/90 (100%) | 90/90 (100%) | 55/90 (61.1%)  |

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|  Table 3. Repeatability Testing Summary Results-B. parapertussis  |   |   |   |
| --- | --- | --- | --- |
|  Bordetella parapertussis | # Detected  |   |   |
|   |  Moderate Positive | Low Positive | High Negative  |
|  BPP A747 | 45 | 45 | 30  |
|  BPP E838 | 45 | 45 | 32  |
|  % Detected | 90/90 (100%) | 90/90 (100%) | 62/90 (68.9%)  |
|  Table 4. Repeatability Testing Summary Results-Controls  |   |   |
| --- | --- | --- |
|  Samples | # Detected | % Detected  |
|  Negative Specimen | 0 | 0  |
|  Negative Control | 0 | 0  |
|  BP Positive Control | 90 | 100  |
|  BPP Positive Control | 90 | 100  |

A multi-center reproducibility study was conducted using two different four-sample panel sets each consisting of three levels of combined B. pertussis (BP) and B. parapertussis (BPP) (two (2) strains of each organism) contrived samples and a negative contrived sample. Set 1 consisted of BP A639 and BPP A747, Set 2 consisted of BP E431 and BPP E838. Samples were diluted in negative nasal matrix (UTM) to 2x LoD for moderate positive, 1x LoD for low positive and diluted to concentrations below the LoD (i.e.,  $C_{20}$  to  $C_{80}$ ) for high negative samples. Negative nasal matrix without spiked organism was used for the negative sample. Positive and negative controls were run in triplicate along with the panels.

Panels and controls were tested over five days at three testing sites by two (2) operators per instrument for five (5) days with each sample tested in three (3) replicates, for a total of 45 results per level for each organism strain (2 operators x 5 days x 3 sites x 3 replicates). Results are shown in Table 5 below.

|  Table 5. Reproducibility Summary  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | SITE |   |   |   |   |   | Overall Percent Agreement | 95% Confidence Interval  |
|   |  Site #1 |   | Site #2 |   | Site #3  |   |   |   |
|   |  # Expected Result/# tested | % Agreement with Expected Result | # Expected Result/# tested | % Agreement with Expected Result | # Expected Result/# tested | % Agreement with Expected Result  |   |   |

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|  Table 5. Reproducibility Summary  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | SITE |   |   |   |   |   | Overall Percent Agreement | 95% Confidence Interval  |   |
|   |  Site #1 |   | Site #2 |   | Site #3  |   |   |   |   |
|   |  # Expected Result/# tested | % Agreement with Expected Result | # Expected Result/# tested | % Agreement with Expected Result | # Expected Result/# tested | % Agreement with Expected Result  |   |   |   |
|  BP strain A639 High Negative1 (103 CFU/mL) | 7/15 | 46.6 | 7/15 | 46.6 | 6/15 | 40.0 | 20/45 | 44.4 | 30.9 to 58.8  |
|  BP strain A639 Low Positive (1025 CFU/mL) | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |
|  BP strain A639 Moderate Positive (2050 CFU/mL) | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |
|  BP strain E431 High Negative1 (86 CFU/mL) | 4/15 | 26.7 | 10/15 | 66.7 | 7/15 | 46.6 | 21/45 | 46.7 | 32.9 to 60.9  |
|  BP strain E431 Low Positive (862 CFU/mL) | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |
|  BP strain E431 Moderate Positive (1724 CFU/mL) | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |
|  BPP strain A747 High Negative1 (462 CFU/mL) | 6/15 | 40.0 | 7/15 | 46.6 | 1/15 | 6.7 | 12/45 | 26.7 | 16.0 to 41.0  |
|  BPP strain A747 Low Positive (4622 CFU/mL) | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |
|  BPP strain A747 Moderate Positive (9244 CFU/mL) | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |
|  BPP strain E838 High Negative1 (553CFU/mL) | 6/15 | 40.0 | 8/15 | 53.3 | 3/15 | 20.0 | 17/45 | 37.8 | 25.1 to 52.4  |
|  BPP strain E838 Low Positive (5533 CFU/mL) | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |
|  BPP strain E838 Moderate Positive | 15/15 | 100 | 15/15 | 100 | 15/15 | 100 | 45/45 | 100 | 92.1 to 100  |

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|  Table 5. Reproducibility Summary  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | SITE |   |   |   |   |   | Overall Percent Agreement | 95% Confidence Interval  |   |
|   |  Site #1 |   | Site #2 |   | Site #3  |   |   |   |   |
|   |  # Expected Result/# tested | % Agreement with Expected Result | # Expected Result/# tested | % Agreement with Expected Result | # Expected Result/# tested | % Agreement with Expected Result  |   |   |   |
|  (11,066 CFU/mL) |  |  |  |  |  |  |  |  |   |
|  Negative Sample | 0/30 | 100 | 0/30 | 100 | 0/30 | 100 | 0/90 | 100 | 95.9 to 100  |
|  BP Positive Control | 30/30 | 100 | 30/30 | 100 | 30/30 | 100 | 90/90 | 100 | 95.9 to 100  |
|  BPP Positive Control | 30/30 | 100 | 30/30 | 100 | 30/30 | 100 | 90/90 | 100 | 95.9 to 100  |
|  Negative Control | 0/30 | 100 | 0/30 | 100 | 0/30 | 100 | 0/90 | 100 | 95.9 to 100  |

1 An expected result for the high negative sample is percent positivity between 20 and 80%.

The results suggest that there are no significant differences in assay performance between different users and different sites on different days.

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

Contrived BP and BPP positive specimens were prepared by diluting BP or BPP cells to the 2x LOD concentration of each target in 3 mL of negative matrix for each of the eight transport media types that are claimed for use with the Solana Bordetella Assay: Molecular Grade Water, Saline (0.9%), Tris-EDTA, Amies Liquid transport media (or Eswab), M4, M4-RT, M5, and UTM were tested with one validation lot of reagents and the Solana Bordetella assay workflow.

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The specimens were stored at three different storage conditions— $\leq -70^{\circ}\mathrm{C}$ ,  $2^{\circ}\mathrm{C}$  to  $8^{\circ}\mathrm{C}$ ,  $25^{\circ}\mathrm{C} \pm 3^{\circ}\mathrm{C}$ . Testing indicated that specimens can be stored before processing at  $2^{\circ}$  to  $8^{\circ}\mathrm{C}$  for up to 97 hours, up to 49 hours at  $25^{\circ}\mathrm{C}$ , or up to 5-months at  $\leq -70^{\circ}\mathrm{C}$ .

No significant difference in assay performance was seen between the four different types of viral transport media, saline (0.85%), Tris EDTA, Molecular Grade Water, or Amies.

# Processed Specimen Stability

Contrived samples were prepared in negative nasal matrix with organism concentrations of 2x LOD for BP (Strain A639, 2050 CFU/mL) and 2x LOD for BPP (Strain E838, 11066 CFU/mL). The stability of samples in Process Buffer at  $2^{\circ}\mathrm{C}$  to  $8^{\circ}\mathrm{C}$  and at  $25^{\circ}\mathrm{C} \pm 3^{\circ}\mathrm{C}$  before and after heat lysis was evaluated in this study. Three (3) replicates were processed and tested before heat lysis and after heat lysis conditions according to the instructions for use. The condition, before or after heating, and testing time points for the corresponding samples in Process Buffer kept at the evaluated temperatures are listed in Table 6 below.

|  Table 6. Process Specimen Stability Conditions  |   |
| --- | --- |
|  Lysis Buffer Tubes | Time Points Tested  |
|  Before Heating | 0, 24, 48, 72, 73 hours  |
|  After Heating | 0, 24, 48, 72, 73 hours  |

Results from the study demonstrated that BP- and BPP-positive samples in Process Buffer generated the expected positive results after storage at at  $2^{\circ}\mathrm{C}$  to  $8^{\circ}\mathrm{C}$  for 97 hours and at  $25^{\circ}\mathrm{C} \pm 3^{\circ}\mathrm{C}$  for 49 hours both before and after undergoing heat lysis.

# Controls

# Process Control

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 used for each specimen.

# External Controls

Controls (Quidel Molecular Bordetella Control Set, which contains positive and negative controls and serves as an external processing control) were run on the Solana Bordetella Complete Assay each day of testing during the clinical study. A total of 117 positive controls (BP-positive and BPP-positive) and 117 negative controls (BP- and BPP-negative) were evaluated across five (5) clinical test sites.

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All controls produced the expected results.

These controls are described as follows:

- The Quidel Molecular Bordetella 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 Quidel Molecular Bordetella 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 carry-over) by B. pertussis and B. parapertussis DNA or amplicon.

It is recommended that the reactivity of each new lot and each new shipment of the Solana Bordetella Complete Assay be verified on receipt and before use using the Quidel Molecular Bordetella Control Set External control tests should be performed thereafter in accordance with appropriate federal, state and local guidelines. The Solana Bordetella Complete Assay should not be used in patient testing if the external controls do not produce the correct results.

d. Limit of Detection

The analytical sensitivity (limit of detection or LoD) of the Solana Bordetella Complete Assay was determined using quantified (CFU/mL) cultures of two (2) BP strains (A639 and E431) and two (2) BPP strains (A747 and E838) serially diluted in a negative nasal matrix. Results are presented in Table 7.

|  Table 7. Limit of Detection  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Target Type | Target | Validation Lot | Determined LOD  |   |
|   |   |   |  CFU/mL | CFU/Assay  |
|  Fresh Cells | BP Strain: A639 | 1 | 1025 | 1.71  |
|   |   |  2 | 1025 | 1.71  |
|   |   |  3 | 1025 | 1.71  |
|   |  BP Strain: E431 | 1 | 863 | 1.44  |
|   |   |  2 | 863 | 1.44  |
|   |   |  3 | 863 | 1.44  |
|   |  BPP Strain: A747 | 1 | 4622 | 7.70  |
|   |   |  2 | 4622 | 7.70  |
|   |   |  3 | 4622 | 7.70  |
|   |  BPP Strain: E838 | 1 | 5533 | 9.22  |
|   |   |  2 | 5533 | 9.22  |

{12}

13

|  Table 7. Limit of Detection  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Target Type | Target | Validation Lot | Determined LOD  |   |
|   |   |   |  CFU/mL | CFU/Assay  |
|   |   |  3 | 5533 | 9.22  |
|  Assay LOD: BP |   |   | 1025 | 1.71  |
|  Assay LOD: BPP |   |   | 5533 | 9.22  |

e. Inclusivity

The reactivity of the Solana Bordetella Complete Assay was evaluated against an additional eight (8) Bordetella pertussis (BP) and eight (8) Bordetella parapertussis (BPP) strains that were not used for LOD determination. The testing was performed at 1x LOD (1025 CFU/mL and 5533 CFU/mL, respectively) level of the assay. All additional sixteen (16) strains were detected in the Solana Bordetella Complete Assay (Table 8).

|  Table 8. Inclusivity Strains  |   |
| --- | --- |
|  BP Strains Detected at 1X LOD (1025 CFU/mL) | BPP Strains Detected at 1X LOD (5533 CFU/mL)  |
|  ATCC 9340 | ZeptoMetrix C510  |
|  ATCC 9797 | ZeptoMetrix E595  |
|  ATCC BAA-1335 | ATCC 15311  |
|  ATCC BAA-589 | ATCC 15989  |
|  ATCC 51445 | ATCC 53892  |
|  ATCC 10380 | ATCC 53893  |
|  ATCC 8478 | ATCC BAA-587  |
|  ATCC 12743 | ATCC 15237  |

To supplement inclusivity testing for each Solana Bordetella Complete assay target, in-silico analysis was performed as an additional evaluation of Solana Bordetella BP and BPP amplicon sequence for the predicted detection of microorganism strains.

f. Analytical Specificity:

Cross-Reactivity

Based on in-silico analysis, B. holmesii and B. bronchiseptica genomes are expected to share complete or nearly complete sequence identity with the BP amplicon because both contain the IS481 sequence. Therefore, these organisms are expected to cross-react with the Solana Bordetella Assay. Other microorganisms are not expected to cause cross-reactivity because their sequence alignment with the BP amplicon shows multiple mismatches in the primer and probe binding regions. It is also be noted that

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no Bordetella parapertussis sequences were retrieved from the blastn search, suggesting that there is little to no sequence identity shared between  $B$  parapertussis and the BP amplicon. Therefore, the BP primers are not expected to amplify any BPP sequences.

Furthermore, based on in-silico analysis, the  $B$  . bronchiseptica genome is expected to share complete or nearly complete sequence identity with the BPP amplicon because it contains the IS1001 sequence. Therefore, it is expected to cross-react with the Solana Bordetella Assay. Other microorganisms are not expected to cause crossreactivity because their sequence alignment with the BPP amplicon shows multiple mismatches in the primer and probe binding regions, which are not likely to promote BPP primer or probe binding. It is also be noted that no Bordetella pertussis sequences were retrieved from the blastn search, suggesting that there is little to no sequence identity shared between BP and the BPP amplicon. Therefore, the BPP primers are not expected to amplify any BP sequences.

A study was performed to determine if eighty-three (83) microorganisms or viruses likely to be present in nasopharyngeal swabs cross-react with the Solana Bordetella Complete Assay. The microorganisms (Table 9, 10, 11) were tested above clinically relevant levels (bacteria/yeast  $\geq 1\mathrm{x}10^{6}$  CFU/mL, viruses  $1\mathrm{x}10^{5}$  TCID50/mL).

Five (5) non-BP organism strains tested positive for BP for all three (3) replicates. The five organisms include 4 of 4 Bordetella holmesii strains (ZeptoMetrix F061, ATCC 51541, ATCC 700053, and ATCC 700052) and 1 of 8 Bordetella bronchiseptica strains (ATCC 4617). Cross-reactivity with these organisms is expected due to the presence of the BP target sequence, IS481, in the genomes of these organisms.

None of the potentially cross-reactive organisms tested positive for BPP.

High levels of BP did not generate any BPP-positive results, and high levels of BPP did not generate any BP-positive results demonstrating no cross-reactivity between the two organism targets.

|  Table 9. Organism - Bacteria  |   |   |
| --- | --- | --- |
|  Acinetobacter baumanii | Bordetella pertussis A639 | Legionella pneumophilia  |
|  Arcanobacterium haemolyticum | Bordetella petrii | Moraxella catarrhalis  |
|  Bacteroides fragilis | Bordetella trematum | Morganella morganii  |
|  Bordetella avium | Burkholderia cenocepacia | Mycobacterium avium  |
|  Bordetella bronchiseptica (ATCC 780) | Burkholderia cepacia | Mycobacterium tuberculosis (avirulent)  |
|  Bordetella bronchiseptica (ZeptoMetrix 801649) | Burkholderia multivorans | Mycoplasma pneumoniae  |

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|  Table 9. Organism - Bacteria  |   |   |
| --- | --- | --- |
|  Bordetella bronchiseptica (ATCC 4617) | Burkholderia thailandensis | Neisseria gonorrhoeae  |
|  Bordetella bronchiseptica (ATCC 10580) | Chlamydia trachomatis | Neisseria meningitidis  |
|  Bordetella bronchiseptica (ATCC BAA-588) | Chlamydophila pneumoniae | Neisseria mucosa  |
|  Bordetella bronchiseptica (ATCC 785) | Corynebacterium diphtheriae | Parvimonas micra  |
|  Bordetella bronchiseptica (ATCC 786) | Enterobacter aerogenes | Proteus mirabilis  |
|  Bordetella bronchiseptica (ATCC 14064) | Enterococcus faecalis | Proteus vulgaris  |
|  Bordetella hinzii | Escherichia coli | Pseudomonas aeruginosa  |
|  Bordetella holmesii (ZeptoMetrix F061) | Fusobacterium necrophorum | Staphylococcus aureus (MRSA)  |
|  Bordetella holmesii (ATCC 51541) | Haemophilus influenzae | Staphylococcus epidermidis  |
|  Bordetella holmesii (ATCC 700053) | Klebsiella pneumoniae | Stenotrophomonas maltophilia  |
|  Bordetella holmesii (ATCC 700052) | Lactobacillus acidophilus | Streptococcus pneumoniae  |
|  Bordetella parapertussis E838 | Lactobacillus plantarum | Streptococcus pyogenes  |
|   |  | Streptococcus salivarius  |
|  Table 10. Yeast  |
| --- |
|  Candida albicans  |
|  Table 11. Viruses  |   |
| --- | --- |
|  Adenovirus 31 | HSV Type 2 G strain  |
|  Coronavirus 229E | Influenza A/Mexico/4108/2009  |
|  Coronavirus NL63 | Influenza B/Florida/04/2006  |
|  Coronavirus OC43 | Measles virus  |
|  Coxsackievirus B4 | Metapneumovirus A1  |
|  Coxsackievirus B5/10/2006 | Mumps virus  |
|  Echovirus 6 | Parainfluenza Type 1 (#2)  |
|  Echovirus 7 | Parainfluenza Type 2 (Greer)  |
|  Echovirus 9 | Parainfluenza Type 3 (C234)  |
|  Echovirus 11 | Parainfluenza Type 4 (VR-1377)  |
|  Enterovirus 70 | Respiratory Syncytial Virus A  |
|  Enterovirus 71 | Rhinovirus 1A  |
|  Epstein-Barr Virus | Varicella Zoster Virus  |
|  HSV Type 1 MacInytre strain |   |

{15}

16

# Microbial Interference

A study was performed to determine if eighty-three (83) microorganisms or viruses likely to be present in nasopharyngeal specimens interfere with detection of the *Bordetella pertussis* (BP) or *Bordetella parapertussis* (BPP) with the Solana Bordetella Complete Assay. Samples were prepared with one BP strain (A639) and one BPP strain (E838) at 2x LoD (2050 CFU/mL and 11066 CFU/mL, respectively) combined with each potentially interfering microorganism. The potentially interfering microorganisms (Table 9, 10, 11) were tested above clinically relevant levels (bacteria/yeast ≥ 1×10⁶ CFU/mL, viruses 1×10⁵ TCID50/mL).

None (0) of the organisms or viruses tested above interfered with the performance of the Solana Bordetella Complete Assay for detection of BP or BPP.

High levels of BP A639 did not cause interference with BPP E838 detection, and high levels of BPP E838 did not cause interference with BP A639 detection.

# Interfering Substances

The performance of Solana Bordetella Complete Assay was evaluated with sixteen (16) potentially interfering substances that may be present in nasopharyngeal specimens collected to test for *Bordetella pertussis* (BP) and *Bordetella parapertussis* (BPP) infection. The substances listed in Table 12 were diluted in negative nasal matrix and tested in the absence or presence of 2x LOD BP (Strain A639 2050 CFU/mL) and 2x LOD BPP (Strain E838 11066 CFU/mL) in the Solana Bordetella Complete Assay.

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|  Table 12. Interfering Substances  |   |   |   |
| --- | --- | --- | --- |
|  Substance | Concentration Tested | Substance | Concentration Tested  |
|  Cepacol Sore Throat Lozenges | 5% w/v | Neo-Synephrine | 15% v/v  |
|  Halls Cherry Menthol-Lyptus Cough Drops | 15% w/v | Afrin Nasal Spray Original | 15% v/v  |
|  Children's Dimetapp | 15% v/v | Zicam Non-Drowsy Allergy Relief Nasal Gel | 5% v/v  |
|  Chloraseptic Sore Throat Lozenges | 10% w/v | Rite Aid Brand Saline Nasal Spray | 15% v/v  |
|  Ricola Original Swiss Sugar-Free Herb Cough Suppressant Throat Drops | 15% w/v | Zanamivir (Relenza) | 5 mg/mL  |
|  Sucrets Complete Lozenges-Vapor Cherry | 5% w/v | Tobramycin | 4 μg/mL  |
|  Mucin (Bovine Submaxillary Gland, Type I-S) | 5 mg/mL | Mupirocin | 10 mg/mL  |
|  Human Blood, EDTA anticoagulated | 5% v/v | Oseltamivir Phosphate (Tamiflu) | 10 mg/mL  |

Negative sample testing in the presence of each of the sixteen (16) substances produced negative results for 3 of 3 replicates. BP+BPP sample testing at  $2\mathrm{x}$  LoD levels in the presence of each of the 16 substances produced BP and BPP positive results for 3 of 3 replicates. Based on these results, the 16 substances tested in this study are considered to not interfere with the Solana Bordetella Complete Assay.

# g. Carry-over/Cross-contamination

A study was conducted to evaluate the potential for carry-over or cross-contamination for the Solana Bordetella Complete Assay. For the study two (2) samples were prepared: a Bordetella pertussis (BP) positive sample and a BP negative sample. The positive sample was prepared by adding cells of one BP strain with a known titer to negative nasal matrix at the concentration of  $1.0 \times 10^{6} \mathrm{CFU/mL}$ . The negative nasal matrix served as the BP negative sample. In each experiment, the positive samples were alternated with the negative samples and tested using Solana Bordetella Complete Assay to assess the risk of cross contamination. In total, two (2) operators tested a total of 30 positive and 30

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negative samples over a total of five (5) runs. All positive BP samples tested positive and all negative BP samples tested negative. No evidence of carry-over/cross contamination was observed with the Solana Bordetella Complete Assay when performed in accordance with the package insert.

h. Fresh versus frozen study

A study was performed to demonstrate equivalency between fresh and frozen specimens. Two (2) BP strains (A639 394 and E431) and two (2) BPP strains (A747 and E838) were serially diluted in a negative nasal matrix at varying concentrations above and below the assay LOD. The dilutions were tested fresh and then after freezing at -70°C. The dilutions demonstrating at least 95% detection (≥19 of 20) were thawed and re-tested. For all four (4) organism strains tested, the fresh and frozen results matched at LOD concentrations indicating equivalence between fresh and frozen samples when tested with the Solana Bordetella Complete Assay.

i. Assay cut-off:

The preliminary baseline, cut-off, and threshold settings were determined for the Solana Bordetella Complete Assay on the Solana instrument during development. The settings were based on the analysis of negative clinical specimens (these specimens were not part of the clinical study), as well as analysis of contrived specimens for the Limit of Detection Study. The baseline, threshold, and cut-off settings were established and used during the clinical trial.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

A multi-center study was conducted to evaluate the Solana Bordetella Complete Assay using nasopharyngeal swab specimens obtained from patients suspected of having respiratory tract infection attributable to Bordetella pertussis or Bordetella parapertussis. The study was performed from October, 2017 to January, 2018 at one (1) internal and four (4) external sites in the United States. Specimens were collected using either Copan NP flocked swab or rayon swab at the various test sites, and both swab types were used for each site's test of record Bordetella testing. The study collected seven hundred forty-

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one (741) fresh specimens at four (4) sites, and two hundred thirty-three (233) frozen archival specimens at four (4) sites.

Specimen collection followed the FDA guidance entitled “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable”. The gender and age demographics for each category are listed below.

|  Table 13. Combined Fresh Specimen Study–Age and Gender Distribution  |   |   |
| --- | --- | --- |
|  Gender | Female | Male  |
|  Total | 384 | 357  |
|  Age  |   |   |
|  < 2 years | 106 | 137  |
|  3 to 12 years | 99 | 113  |
|  13 to 21 years | 54 | 48  |
|  > 22 years | 125 | 59  |

Testing with contiguous fresh nasopharyngeal swabs on the Solana device was performed at four (4) laboratories. Specimens were eluted into the following sample buffers during the clinical studies: Remel M6 (n=236 or 31.8%), UTM (n=226 or 30.5%), Tris EDTA (n=175 or 23.6%), and Molecular Grade Water (n=104 or 14.0%). An aliquot from each buffer was frozen and shipped on dry ice to the central laboratory for testing with comparator reference assays.

Clinical performance was based on comparison of the Solana Bordetella Complete Assay results to those obtained by a composite reference method that included two (2) manufacturer validated, IS481-targeted real-time PCR assays and bi-directional sequencing. The PCR assay protocols included 37 amplification cycles.

a. Prospective clinical study

Seven hundred forty-one (741) fresh nasopharyngeal swab specimens, obtained from female and male patients suspected of having respiratory tract infection attributable to Bordetella pertussis or Bordetella parapertussis, were prospectively collected and transported to each laboratory for testing with the Solana Bordetella Complete Assay. Four (4) specimens (0.5%) were invalid (in both the initial and repeat test) and have been removed from further analysis. The tables below present the data for the remaining seven hundred thirty-seven (737) specimens.

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20

|  Table 14. Prospective Study: Combined Site Fresh Specimens - Composite Reference Method versus Solana Bordetella Complete Assay for B. pertussis  |   |   |   |
| --- | --- | --- | --- |
|   | Composite Reference Method  |   |   |
|  Solana Bordetella Complete Assay | Positive | Negative | Total  |
|  Positive | 11 | 3 | 14  |
|  Negative | 0 | 723 | 723  |
|  Total | 11 | 726 | 737  |
|  95% CI  |   |   |   |
|  Positive Percent Agreement | 11/11 | 100% | 74.1% to 100%  |
|  Negative Percent Agreement | 723/726 | 99.6% | 98.8% to 99.9%  |
|  Table 15. Prospective Study: Combined Site Fresh Specimens - Composite Reference Method versus Solana Bordetella Complete Assay for B. parapertussis  |   |   |   |
| --- | --- | --- | --- |
|   | Composite Reference Method  |   |   |
|  Solana Bordetella Complete Assay | Positive | Negative | Total  |
|  Positive | 10 | 0 | 10  |
|  Negative | 0 | 727 | 727  |
|  Total | 10 | 727 | 737  |
|  95% CI  |   |   |   |
|  Positive Percent Agreement | 10/10 | 100% | 72.2% to 100%  |
|  Negative Percent Agreement | 727/727 | 100% | 99.5% to 100%  |

b. Retrospective Clinical Study, Archived Specimens

Two hundred thirty-three (233) selected frozen archival specimens were collected at four (4) sites. The frozen archival nasopharyngeal swab specimens were obtained from female and male patients previously tested for the presence of Bordetella pertussis or Bordetella parapertussis. The specimens were tested with the Solana Bordetella Complete Assay and the Composite Reference Method. Archival specimens were eluted into the following sample buffers: Amies (eSwab) (n=17 or 7.3%), UTM (n=102 or 43.8%), Remel M6 (n=48 or 20.6%), 0.85% Saline (n=10 or 4.3%) and Molecular Grade Water (n=56 or 24.0%). An aliquot from each specimen was re-frozen and shipped on dry ice to the central laboratory for testing with comparator assays. The testing with the comparator assays was performed concurrently and in a blinded fashion. The tables below present the data for the specimens.

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|  Table 16. Combined Site Archival Specimens - Composite Reference Method versus Solana Bordetella Complete Assay for B. pertussis  |   |   |   |
| --- | --- | --- | --- |
|   | Composite Reference Method  |   |   |
|  Solana Bordetella Complete Assay | Positive | Negative | Total  |
|  Positive | 155 | 6 | 161  |
|  Negative | 3 | 69 | 72  |
|  Total | 158 | 75 | 233  |
|  95% CI  |   |   |   |
|  Positive Percent Agreement | 155/158 | 98.1% | 94.6% to 99.4%  |
|  Negative Percent Agreement | 69/75 | 92.0% | 83.6% to 96.3%  |
|  Table 17. Combined Site Archival Specimens - Composite Reference Method versus Solana Bordetella Complete Assay for B. parapertussis  |   |   |   |
| --- | --- | --- | --- |
|   | Composite Reference Method  |   |   |
|  Solana Bordetella Complete Assay | Positive | Negative | Total  |
|  Positive | 12 | 3 | 15  |
|  Negative | 0 | 218 | 218  |
|  Total | 12 | 221 | 233  |
|  95% CI  |   |   |   |
|  Positive Percent Agreement | 12/12 | 100% | 75.7% to 100%  |
|  Negative Percent Agreement | 218/221 | 98.6% | 96.1% to 99.5%  |

An additional study was performed to demonstrate the sensitivity of Solana Bordetella Complete Assay using three (3) levels of Bordetella parapertussis (BPP) (two (2) strains) in negative specimen matrix at two (2) testing locations. Each individual contrived specimen was prepared using a unique negative NP specimen matrix.

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|  Table 18. Contrived Bordetella parapertussis Panel Result Summary  |   |   |   |
| --- | --- | --- | --- |
|  Panel Members | # of Samples | BPP Concentrations | Results  |
|  Negative | 20 | 0 | Negative: 100% (20/20)  |
|  BPP Low Positive | 10
10 | 2.5X LOD
BPP A747 (1.2 x10^{4} CFU/mL)
BPP E838 (1.4 x10^{4} CFU/mL) | 100% (10/10)
100% (10/10)  |
|  BPP Moderate Positive | 6
6 | 10X LOD
BPP A747 (4.6 x10^{4} CFU/mL)
BPP E838 (5.5 x10^{4} CFU/mL) | 100% (6/6)
100% (6/6)  |
|  BPP High Positive | 4
4 | 100X LOD
BPP A747 (4.6 x10^{5} CFU/mL)
BPP E838 (5.5 x10^{5} CFU/mL) | 100% (4/4)
100% (4/4)  |
|  Negative Control | 6 | N/A | 0% (0/6)  |
|  BPP Positive Control | 6 | N/A | 100% (6/6)  |

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

The prevalence of Bordetella pertussis and Bordetella parapertussis detected with the Solana Bordetella Complete Assay has been calculated for the combined sites based on the age of the patient. Four (4) specimens (0.5%) were invalid (in both the initial and repeat test) and have been removed from the Expected Values table. The table below presents the data for the remaining seven hundred thirty-seven (737) specimens.

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23
|  Table 19. Combined Fresh Specimen Study Expected Values (N=737)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|  Age | Total # | Bordetella pertussis |   | Bordetella parapertussis  |   |
|   |   |  Total Positive | Prevalence | Total Positive | Prevalence  |
|  ≤2 years | 241* | 3 | 1.2% | 4 | 1.7%  |
|  3 to 12 years | 210** | 4 | 1.9% | 6 | 2.9%  |
|  13 to 21 years | 102 | 6 | 5.9% | 0 | 0.0%  |
|  ≥22 years | 184 | 1 | 0.5% | 0 | 0.0%  |

* Two (2) specimens were invalid
** Two (2) specimens were invalid

N. Instrument Name:

Solana

O. System Descriptions:

1. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?

Yes ☐ X or No ☐

Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?

Yes ☐ or No ☐ X

2. Software:

FDA has reviewed the applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X ☐ or No ☐

3. Specimen Identification:

Nasopharyngeal swab (NPS) specimens collected from the human nasopharynx region.

4. Specimen Sampling and Handling:

N/A

5. Calibration:

N/A

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6. Quality Control:

See Section M.1.c. (Traceability, Stability, Expected values (controls, calibrators, or methods)) for further details.

P. Other Supportive Instrument Performance Characteristics Data Not Covered in the "Performance Characteristics" Section above:

N/A

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

24

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZZ/K181029](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OZZ/K181029)

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