(83 days)
Not Found
No
The device description mentions "on-board method-specific algorithms" for interpreting fluorescent signals, which is standard for many diagnostic devices and does not indicate the use of AI or ML. There is no mention of AI, ML, or related concepts like neural networks or deep learning in the document.
No.
This device is an in vitro diagnostic test designed to detect the presence of Group A B-hemolytic Streptococcus nucleic acids. It does not provide treatment or therapy for a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Solana™ GAS Assay is a "rapid in vitro diagnostic test for the qualitative detection of Group A B-hemolytic Streptococus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat." This directly indicates its diagnostic purpose.
No
The device description clearly outlines a multi-component system including reagents, tubes, and the Solana instrument, which performs amplification and detection using hardware components like fluorescence measurement. While software is involved in interpreting the signal, it is not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Solana™ GAS Assay is a "rapid in vitro diagnostic test".
- Nature of the Test: The device performs a test on a biological specimen (throat swab) in vitro (outside of the body) to detect the presence of a specific substance (Group A B-hemolytic Streptococus nucleic acids) for the purpose of diagnosing a condition (pharyngitis).
- Device Description: The description details the process of preparing and testing the specimen using reagents and an instrument, which is characteristic of an in vitro diagnostic assay.
Therefore, based on the provided information, the Solana™ GAS Assay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Solana™ GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A B-hemolytic Streptococus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana™ GAS Assay is intended for use only with the Solana™ instrument.
Product codes (comma separated list FDA assigned to the subject device)
PGX
Device Description
The Solana™ GAS Assay amplifies and detects GAS DNA present in throat swab specimens obtained from symptomatic patients.
The assay consists of two major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to GAS using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.
Patient specimen on a throat swab is transferred to a Lysis Tube and subjected to heattreatment at 95°C for 5 minutes. The heat-treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of GAS-specific target sequence. In Solana, the target sequence is amplified by GAS specific primers and detected by a GAS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by GAS 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 on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GAS 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 instrument will then report the test results to the user on its display screen, and it can print out the results via a printer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use only.
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
Reproducibility Study:
Sample size: 540 specimens (including controls).
Data Source: Blinded and randomized study panel containing Streptococcus pyogenes negative and positive samples.
Annotation Protocol: Not explicitly stated, but implies the samples were pre-defined as positive or negative for Streptococcus pyogenes. Testing was done at three test sites (one in-house laboratory and two clinical sites) with three (3) instruments. Each site tested a reproducibility panel and Assay Controls for five days in triplicate. Testing was done by two operators at each site. Each operator ran the panel once a day using one lot of Solana™ GAS Assay.
Analytical Sensitivity (Limit of Detection or LoD) Study:
Sample size: 20 replicates for each test dilution.
Data Source: Quantified (CFU/mL) cultures of two Streptococcus pyoqenes strains (ATCC #19615 and ATCC #12344) by serial dilution.
Annotation Protocol: The highest dilution where at least 19 of 20 replicates show detection of GAS (95% positivity) was assigned the Limit of Detection of the strain. The CFU/mL was calculated based on the average bacterial plate count of the dilution.
Cross Reactivity Study:
Sample size: Not explicitly stated, but involved testing 46 other microorganisms.
Data Source: Potentially interfering microorganisms commonly found in throat specimens.
Annotation Protocol: Each potentially interfering microorganism was tested in the presence of 2 x LoD Group A Streptococcus (2 strains) in the presence of clinically relevant levels of viruses (10 pfu/ml) and bacteria (10 cfu/mL) or higher. All strain combinations were spiked on to swabs.
Interference Study:
Sample size: Not explicitly stated, but involved testing 28 common biological and chemical substances.
Data Source: Two strains of Streptococcus pyogenes (ATCC 19615 and 12344) tested near LoD.
Annotation Protocol: Substances were introduced into the assay dilution tubes at concentrations which were medically relevant. Each of the strains was tested for each substance.
Analytical Reactivity (Inclusivity) Study:
Sample size: Three replicates for each strain.
Data Source: Seven additional strains of Streptococcus pyogenes (GAS) (ATCC 12384, NCIMB 13285, CCUG 33061, CCUG 33409, CCUG 39158, ATCC 49399, CCUG 53553).
Annotation Protocol: Each strain was tested at concentrations near the limit of detection (LoD) of the assay. The study was performed in multiple experiments. For each experiment, three replicates of up to three strains were performed, along with a positive and a negative run control.
Clinical Study:
Sample size: One thousand eighty-two (1082) fresh throat swab specimens.
Data Source: Female and male patients collected at four distinct geographical sites across the United States. A single specimen was collected per patient. Samples were collected on Polyester, Nylon or Rayon Swab with liquid Amies or Polyester Swab or Rayon with liquid Stuart's.
Annotation Protocol: The swabs were inoculated by conventional streak-stab culture technique onto a trypticase soy agar plate containing 5% horse red blood cells. Testing with the Solana device was performed at the four external laboratories using the same swab that was plated for the culture. All residual specimen transport media from the samples was shipped daily (with cold packs) to a central location. The transport media was cultured using the same testing protocol as that employed by the clinical sites. The specimen was considered positive if either the swab or the transport media was positive for ß-hemolytic Streptococcus (Composite Culture) and typed as Lancefield group A by latex agglutination.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Analytical Performance - Precision/Reproducibility
Sample Size: 540 specimens (including controls)
Key Results: The results suggest that there are no significant differences between different users using different instruments at different sites on different days.
- GAS High Negative: Overall Percent Positive: 64% (58/90), 95% Confidence Interval: 54-74%
- GAS Low Positive: Overall Percent Positive: 100% (90/90), 95% Confidence Interval: 96%-100%
- GAS Moderate Positive: Overall Percent Positive: 100% (90/90), 95% Confidence Interval: 96%-100%
- GAS Negative: Overall Percent Positive: 0% (0/90), 95% Confidence Interval: 0%-4%
- GAS Positive Control: Overall Percent Positive: 100% (90/90), 95% Confidence Interval: 96%-100%
- GAS Negative Control: Overall Percent Positive: 0% (0/90), 95% Confidence Interval: 0%-4%
Study Type: Analytical Performance - Detection Limit (LoD)
Sample Size: 20 replicates per dilution for each of two Streptococcus pyogenes strains.
Key Results: The LoD for the 2 Streptococcus pyogenes strains tested were 2.44 x10^4 CFU/mL (ATCC #19615) and 6.81 x10^4 CFU/mL (ATCC #12344). The reported LoD for the Solana™ GAS Assay is 6.81 x10^4 CFU/mL.
Study Type: Analytical Performance - Analytical Specificity (Cross Reactivity)
Sample Size: Sixty-one (61) potential interfering organisms for in silico analysis; 46 other microorganisms for wet lab testing.
Key Results: None of the organisms or viruses tested above cross-reacts with the performance of the Solana™ GAS Assay.
Study Type: Analytical Performance - Interference
Sample Size: 28 common biological and chemical substances.
Key Results: None of the substances tested were found to interfere with the Solana™ GAS Assay.
Study Type: Analytical Performance - Analytical Reactivity (Inclusivity)
Sample Size: Seven (7) strains of Streptococcus pyogenes (GAS). Each strain was tested as three replicates.
Key Results: All seven strains were detected by the Solana™ GAS Assay at concentrations near the limit of detection (LoD) of the assay.
Study Type: Clinical Study - Performance characteristics
Sample Size: 1082 fresh throat swab specimens.
Key Results: Overall Performance (All Sites), using Composite Culture as reference:
- Sensitivity: 98.2% (220/224) with 95% CI: 95.5% to 99.3%
- Specificity: 97.2% (833/857) with 95% CI: 95.9% to 98.1%
Discordant specimens analysis:
- Of the 24 false positives, 16 were positive for GAS when tested with an additional FDA-cleared molecular device, 8 were negative.
- Of the 4 false negatives, 3 were negative when tested with an additional FDA-cleared molecular device.
Site-specific Performance:
- Site 1: Sensitivity 98.4% (60/61), Specificity 98.5% (333/338)
- Site 2: Sensitivity 98.6% (69/70), Specificity 93.7% (134/143)
- Site 3: Sensitivity 100% (29/29), Specificity 96.9% (186/192)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Performance (All Sites):
- Sensitivity: 98.2% (95% CI: 95.5% to 99.3%)
- Specificity: 97.2% (95% CI: 95.9% to 98.1%)
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.
Lyra™ Direct Strep, K133883
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
§ 866.2680
Streptococcus spp. nucleic acid-based assay.(a)
Identification. AStreptococcus spp. nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify variousStreptococcus spp. nucleic acids extracted directly from clinical specimens. The device detects specific nucleic acid sequences for organism identification. 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 II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation, including the device components, ancillary reagents required but not provided, and a detailed explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection.
(2) Premarket notification submissions must include detailed documentation from the following analytical and clinical performance studies: Analytical sensitivity (Limit of Detection), reactivity, inclusivity, precision, reproducibility, interference, cross reactivity, carry-over, and cross contamination.
(3) Premarket notification submissions must include detailed documentation from a clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods.
(4) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, software applications and hardware-based devices that incorporate software.
(5) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols, as appropriate.
(6) The device labeling must include limitations regarding the need for culture confirmation of negative specimens, as appropriate.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(8) Premarket notification submissions must include details on an end user device training program that will be offered while marketing the device, as appropriate.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1st, 2015
QUIDEL CORPORATION RONALD H. LOLLAR SENIOR DIRECTOR, CLINICAL AND REGULATORY AFFAIRS 2005 EAST STATE STREET, SUITE 100 ATHENS, OH 45701
Re: K150868
Trade/Device Name: Solana™ Gas Assay, Solana™ Instrument Regulation Number: 21 CFR 866.2680 Regulation Name: Streptococcus spp. nucleic acid-based assay Regulatory Class: II Product Code: PGX Dated: March 31, 2015 Received: April 1, 2015
Dear Mr. Lollar:
This letter corrects our substantially equivalent letter of June 23, 2015.
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. Iisting 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 Parts 801 and 809); medical device reporting (reporting of
1
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.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sally A. Hojvat -S
Sally A. Hojvat, 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) K150868
Device Name Solana™ GAS Assay, Solana™ Instrument
Indications for Use (Describe)
The Solana™ GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A B-hemolytic Streptococus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana™ GAS Assay is intended for use only with the Solana™ instrument.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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:
March 31, 2015
A. 510(k) Number:
B. Purpose for Submission:
To obtain substantial equivalence for the Solana™ GAS Assay when performed on the Solana™ instrument
C. Measurand:
DNase B (sdaB) sequence of Streptococcus pyogenes (Group A Streptococcus)
D. Type of Test:
Helicase-dependent amplification (HDA)
4
E. Applicant:
Quidel Corporation
F. Proprietary and Established Names:
Solana™ GAS Assay Solana™ instrument
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| PGX – Groups A, C and G Beta- | |||
| Hemolytic | |||
| Streptococcus | |||
| Nucleic Acid | |||
| Amplification | Class II (Non-exempt) | 21 CFR 866.2680 – Streptococcus spp. Nucleic Acid-Based Assay | Microbiology (83) |
H. Intended Use:
-
- Intended Use(s):
The Solana™ GAS Assay is a rapid in vitro diagnostic test for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat. The Solana™ GAS Assay is intended for use only with the Solana™ instrument.
- Intended Use(s):
-
- Indication(s) for Use:
Same as intended Use
- Indication(s) for Use:
-
- 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™ GAS Assay amplifies and detects GAS DNA present in throat swab specimens obtained from symptomatic patients.
The assay consists of two major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to GAS using isothermal Helicase-Dependent Amplification (HDA) in the presence of target-specific fluorescence probe.
Patient specimen on a throat swab is transferred to a Lysis Tube and subjected to heattreatment at 95°C for 5 minutes. The heat-treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of GAS-specific target sequence. In Solana, the target sequence is amplified by GAS specific primers and detected by a GAS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by GAS 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 on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GAS 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 instrument will then report the test results to the user on its display screen, and it can print out the results via a printer.
Materials Provided:
- 48 Tests per Kit
| Component | Quantity | Storage |
|---|---|---|
| Dilution Buffer | 48 tubes/kit 0. 5 mL | 2° to 8°C |
| Lysis Buffer | 48 tubes/kit 0. 5 mL | 2° to 8°C |
| Reaction Tubes | 48 tubes/kit | 2° to 8°C |
6
Materials required but not provided:
- . External controls for Group A Streptococcus (e.g. Quidel Molecular A + G Streptococci Control Set #M111, which contains positive and negative controls, serves as an external processing and extraction control)
- Sterile DNAse-free filter-blocked or positive displacement micropipettor tips
- Micropipettor
- Stopwatch or timer
- Scissors or a blade
- Micro tube tray ●
- Heat block capable of 95° C ± 2° C temperature ●
- Solana Instrument
- Thermometer
J. Substantial Equivalence Information:
-
- Predicate device name(s):
Lyra™ Direct Strep
- Predicate device name(s):
-
- Predicate 510(k) number(s): K133883
-
- Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Solana™ GAS Assay | Lyra™ Direct Strep Assay |
| (K133883) | ||
| Intended Use | The Solana™ GAS Assay is a | |
| rapid in vitro diagnostic test | ||
| for the qualitative detection | ||
| of Group A β-hemolytic | ||
| Streptococcus | ||
| ( Streptococcus pyogenes ) | ||
| nucleic acids isolated from | ||
| throat swab specimens | ||
| obtained from patients with | ||
| signs and symptoms of | ||
| pharyngitis, such as sore | ||
| throat. The Solana™ GAS | The Lyra Direct Strep | |
| Assay is a Real-Time PCR | ||
| in vitro diagnostic test for | ||
| the qualitative detection | ||
| and differentiation of | ||
| Group A β-hemolytic | ||
| Streptococcus | ||
| ( Streptococcus pyogenes ) | ||
| and pyogenic Group C | ||
| and G β-hemolytic | ||
| Similarities | ||
| Item | Solana™ GAS Assay | Lyra™ Direct Strep Assay |
| (K133883) | ||
| Assay is intended for use | ||
| only with the Solana™ | ||
| instrument. | Streptococcus nucleic | |
| acids isolated from | ||
| throat swab specimens | ||
| obtained from patients | ||
| with signs and symptoms | ||
| of pharyngitis, such as | ||
| sore throat. The assay | ||
| does not differentiate | ||
| between pyogenic | ||
| Groups C and G β- | ||
| hemolytic Streptococcus . |
All negative test results
should be confirmed by
bacterial culture,
because negative results
do not preclude Group A,
C or G Strep infection
and should not be used
as the sole basis for
treatment.
The assay is intended for
use in hospital, reference,
or state laboratory
settings. The device is not
intended for point-of-care
use. |
| Similarities | | |
| Item | Solana™ GAS Assay | Lyra™ Direct Strep Assay
(K133883) |
| Sample Types | Throat swab specimens | Same |
| Sample Heat Lysis | Manual | Same |
| Detection Technique | Automatically detects
fluorescence after
dissociation of fluorophore
from quencher during
amplification | Same |
| Testing Time | 45 minutes | 60 - 70 minutes |
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8
| Differences | ||
|---|---|---|
| Item | Solana™ GAS Assay | Lyra™ Direct Strep Assay |
| (K133883) | ||
| DNA Amplification | ||
| Technology | Helicase-dependent | |
| amplification (HDA); self-contained | Real time polymerase | |
| chain reaction | ||
| Instrument | Solana™ | ABI 7500 Fast DX |
| Thermocycler | ||
| Target Sequence Detected | 78 base pair (bp) sequence | |
| S. pyogenes genome, | ||
| resident in the DNase B | ||
| ( sdaB ) gene | GAS* – 99bp product in | |
| the putative competence | ||
| ( comX1.1 ) gene |
Pyo GCS/GGS* – 188bp
product in the tagatose-6-
phosphate kinase ( lacC )
gene |
| Clinical Sensitivity | 98.2% (95% CI: 95.5-99.3%) | GAS Sensitivity:
96.5%[95% CI: 91.3% - |
9
| Differences | ||
|---|---|---|
| Item | Solana™ GAS Assay | Lyra™ Direct Strep Assay (K133883) |
| 98.6% | ||
| Pyo GCS/GGS Sensitivity: | ||
| 95.7%[95% CI: 88.1% - 98.5%] | ||
| Clinical Specificity | 97.1% (95% CI: 95.7-98.0%) | GAS Specificity: |
| 98.0%[95% CI: 97.0% - 98.6%] | ||
| Pyo GCS/GGS Specificity: | ||
| 98.3%[95% CI: 97.4% - 98.9%] |
K. Standard/Guidance Document Referenced (if applicable):
screen, and it can print out the results via a printer.
Not applicable
L. Test Principle:
Patient specimen on a throat swab is transferred to a Lysis Tube and subjected to heattreatment at 95°C for 5 minutes. The heat-treated sample is added to a Dilution Tube, and then transferred to a Reaction Tube. The Reaction Tube contains lyophilized HDA reagents, dNTPs, primers and probes. Once rehydrated with the diluted sample, the Reaction Tube is placed in Solana for amplification and detection of GAS-specific target sequence. In Solana, the target sequence is amplified by GAS specific primers and detected by a GAS specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC target is amplified by GAS 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 on the other end. In addition, the target and PRC probes carry a ribonucleic acid. Upon annealing to GAS 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 instrument will then report the test results to the user on its display
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M. Performance Characteristics:
1. Analytical performance:
- a. Precision/Reproducibility:
Reproducibility
In order to confirm the reproducibility of the Solana™ GAS Assay, a blinded and randomized study panel containing Streptococcus pyogenes negative and positive samples were tested at three test sites (one in-house laboratory and two clinical sites) with three (3) instruments. Each site tested a reproducibility panel and Assay Controls for five days in triplicate. Testing was done by two operators at each site. Each operator ran the panel once a day using one lot of Solana™ GAS Assay. A total of 540 specimens were tested (including controls). The Solana™ GAS Assay generated the following reproducible results in this study.
| Category | SITE | Overall Percent Positive | 95% Confidence Interval | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Site #1 | Site #2 | Site #3 | |||||||
| Detected: | |||||||||
| #positive /# tested | % Positive | Detected: | |||||||
| #positive /# tested | % Positive | Detected: | |||||||
| #positive /# tested | % Positive | ||||||||
| GAS High Negative | 24/30 | 80% | 20/30 | 67% | 14/30 | 47% | 58/90 | 64% | 54-74% |
| GAS Low Positive | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 90/90 | 100% | 96%-100% |
| GAS Moderate Positive | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 90/90 | 100% | 96%-100% |
| GAS Negative | 0/30 | 0% | 0/30 | 0% | 0/30 | 0% | 0/90 | 0% | 0%-4% |
| GAS Positive Control | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 90/90 | 100% | 96%-100% |
| GAS Negative Control | 0/30 | 0% | 0/30 | 0% | 0/30 | 0% | 0/90 | 0% | 0%-4% |
The results suggest that there are no significant differences between different users using different instruments at 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):
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Traceability:
Not applicable. This assay is qualitative.
Specimen Stability:
A study was performed to determine the stability of samples collected in a number of routinely used swab systems: nylon flocked swabs in amies media, Rayon swab in amies media, polyester swab in amies media, Rayon swab in stuart media, polyester swab in stuart media, and Rayon in amies gel.
A freshly grown stock of GAS bacteria of known titer was used to spike the swabs listed above. The spiked samples were stored at 25°C ± 2°C for 2 days and then at 2 to 8°C for up to 8 more days prior to being tested in the Solana™ GAS Assay. A separate study was performed where the spiked samples were stored at ≤-15℃ or 2 Includes B. ovatus
3 Includes C. rectus
4 In NCBI, Bacteroides oralis is Prevotella oralis.
5 In NCBI, Peptostreptococcus micros is Parvimonas micra.
14
A study was performed to evaluate the performance of the Solana™ GAS Assay in the presence of forty-six (46) other microorganisms commonly found in throat specimens. Each potentially interfering microorganism was tested in the presence of 2 x LoD Group A Streptococcus (2 strains) in the presence of clinically relevant levels of viruses (10 pfu/ml) and bacteria (10 cfu/mL) or higher. All strain combinations were spiked on to swabs. The strains included in the cross-reactivity study are shown in the table below.
| Acinetobacter Iwoffii | Staphylococcus epidermidis MRSE |
|---|---|
| Arcanobacterium haemolyticum | Stenotrophomonas maltophilia |
| Bacillus cereus | Streptococcus agalactiae |
| Bordetella pertussis | Streptococcus anginosus |
| Burkholderia cepacia | Streptococcus bovis |
| Corynebacterium diphtheria | Streptococcus canis |
| Enterococcus faecalis | Streptococcus dysgalactiae subsp equisimilis |
| Escherichia coli | Streptococcus gordonii (Virdans type) |
| Fusobacterium necrophorum | Streptococcus intermedius |
| Haemophilus influenza type A | Streptococcus mitis |
| Klebsiella pneumonia | Streptococcus mutans |
| Lactobacillus acidophilus | Streptococcus oralis |
| Lactococcus lactis | Streptococcus pneumoniae |
| Legionella jordanis | Streptococcus salivarius |
| Legionella micdadei | Streptococcus sanguinis |
| Legionella pneumophila | Streptococcus suis |
| Moraxella cartarrhalis | Candida albicans |
| Neisseria gonorrhoeae | Adenovirus Type 1 |
| Neisseria subflava | Adenovirus Type 11 (Slobitski) |
| Peptostreptococcus micros (aka Parvimonas | |
| micra) | Influenza A |
| Pseudomonas aeruginosa | Influenza B |
| Serratia marcescens | Parainfluenza Type 4B (VR-1377) |
| Staphylococcus aureus MRSA | Rhinovirus Type 15 (1734) |
None of the organisms or viruses tested above cross-reacts with the performance of the Solana™ GAS Assay.
15
Interference:
A study was conducted using two strains of Streptococcus pyogenes (ATCC 19615 and 12344) tested near LoD to evaluate the Solana™ GAS Assay for potential interference using a panel consisting of twenty-eight (28) common biological and chemical substances found in throat samples. Substances were introduced into the assay dilution tubes at concentrations which were medically relevant. Each of the strains was tested for each substance. None of the substances tested were found to interfere with the Solana™ GAS Assay.
| Substance Name | Test
Concentration | Interference?
(Y/N) |
|----------------------------------------------------|-----------------------|------------------------|
| Children's Dimetapp
DM Cold & Cough
Elixir | 25% v/v | No |
| Chloraseptic Max:
Sore Throat Relief | 10% v/v | No |
| BreathSavers 3 Hour
Mint-Spearmint | 10% w/v | No |
| Cepacol Sore Throat:
Cherry Flavor | 5% w/v | No |
| Robitussin Cough &
Cold-CF Max | 10% v/v | No |
| Ricola Mountain
Herb Throat
Drops-Sugar Free | 15% w/v | No |
| Human Saliva | 10% v/v | No |
| Robitussin Nighttime
Cold, & Flu | 10% v/v | No |
| Crest Pro-Health
Night Mint | 25% v/v | No |
| CVS Tussin CF | 15% v/v | No |
| Chloraseptic Throat
Cherry lozenge | 10% w/v | No |
| Halls Cherry
Mentholyptus | 15% w/v | No |
| Tic Tac Freshmints | 10% w/v | No |
| Zicam® Oral Mist | 0.625% v/v | No |
16
| Substance Name | Test
Concentration | Interference?
(Y/N) |
|-----------------------------------------------------------------------------------------|-----------------------|------------------------|
| Sucrets
Complete-Vapor
Cherry | 5% w/v | No |
| Acetaminophen | 19.5 mg/mL | No |
| Aspirin | 12.3 mg/mL | No |
| Ibuprofen | 15.6 mg/mL | No |
| Benadryl | 2.7 mg/mL | No |
| Crest® Complete
Toothpaste | 5% w/v | No |
| Contac® Cold + Flu
Caplets Night | 10% w/v | No |
| Children's Wal-Tap
Elixir Cold & Allergy
(Dimetap Children's
Cold and Allergy) | 25% v/v | No |
| Children's Wal-Tap
DM Elixir Cold &
Cough | 25% v/v | No |
| Robitussin Nighttime
Cough, Cold, & Flu
(peak cold) | 10% v/v | No |
| Halls Mentholyptus
(not cherry flavor) | 15% w/v | No |
| Listerine Cool Mint
Antiseptic | 15% v/v | No |
| Whole Blood | 5% v/v | No |
| Mucin (Bovine
Submaxillary Gland,
type I-S) | 5.0 mg/mL | No |
Analytical Reactivity (Inclusivity):
The reactivity of the Solana™ GAS Assay was evaluated against an additional seven (7) strains of Streptococcus pyogenes (GAS) at concentrations near the limit of detection (LoD) of the assay.
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Each strain was tested as three replicates in the Solana™ GAS Assay. The study was performed in multiple experiments. For each experiment, three replicates of up to three strains were performed, along with a positive and a negative run control. All seven strains were detected by the Solana™ GAS Assay.
| Bacterial Strain | Concentration
CFU/mL | Strain Detected
(Yes/No) |
|------------------|-------------------------|-----------------------------|
| ATCC 12384 | $6.81 x10^4$ | Yes |
| NCIMB 13285 | $6.81 x10^4$ | Yes |
| CCUG 33061 | $6.81 x10^4$ | Yes |
| CCUG 33409 | $6.81 x10^4$ | Yes |
| CCUG 39158 | $6.81 x10^4$ | Yes |
| ATCC 49399 | $6.81 x10^4$ | Yes |
| CCUG 53553 | $6.81 x10^4$ | Yes |
- f. Assay cut-off:
Not applicable.
2. Comparison studies:
-
a. Method comparison with predicate device:
Not applicable -
b. Matrix comparison:
A comparison study was conducted between negative clinical matrix and the contrived negative matrices used in the analytical studies in order to validate their use. The matrix comparison study results are shown in the table below.
18
| | | Contrived Negative
Matrix | | Pooled Negative Clinical
Matrix | |
|-------------------------------------------------------|---------|------------------------------|-------|------------------------------------|-------|
| | | Detected | % Pos | Detected | % Pos |
| Streptococcus
pyogenes
ATCC 19615 | 1 x LoD | 20/20 | 100% | 20/20 | 100% |
These studies demonstrate that the contrived negative matrices do not alter the performance of the device in the context of these analytical studies.
3. Clinical studies:
a. Clinical Sensitivity:
Performance characteristics of the Solana GAS Assay were established during a prospective study conducted December 2014 to February 2015. One thousand eighty-two (1082) fresh throat swab specimens from female and male patients were collected at four distinct geographical sites across the United States. A single specimen was collected per patient. Samples were collected on Polyester, Nylon or Rayon Swab with liquid Amies or Polyester Swab or Rayon with liquid Stuart's. The swabs were inoculated by conventional streak-stab culture technique onto a trypticase soy agar plate containing 5% horse red blood cells. Testing with the Solana device was performed at the four external laboratories using the same swab that was plated for the culture. All residual specimen transport media from the samples was shipped daily (with cold packs) to a central location. The transport media was cultured using the same testing protocol as that employed by the clinical sites.
One thousand eighty-two (1082) fresh throat specimens were cultured for Group A β-hemolytic Streptococcus and tested with the Solana GAS Assay. The specimens were cultured at the testing sites and the transport media was cultured at a central location. The specimen was considered positive if either the swab or the transport media was positive for ß-hemolytic Streptococcus (Composite Culture) and typed as Lancefield group A by latex agglutination. The table below details the overall performance using composite culture results as a reference.
19
| Performance Results of Solana GAS Assay for Group A β-hemolytic Streptococcus | |||
|---|---|---|---|
| Overall Performance (All Sites) | |||
| Solana GAS Assay | Composite Culture Positive | Negative | Total |
| Positive | 220 | 24* | 244 |
| Negative | 4** | 833 | 837 |
| Total | 224 | 857 | 1081 |
| 95% CI | |||
| Sensitivity | 220/224 | 98.2% | 95.5% to 99.3% |
| Specificity | 833/857 | 97.2% | 95.9% to 98.1% |
| * Of the twenty-four (24) discordant specimens, sixteen (16) of these specimens were | |||
| positive for GAS when tested with an additional FDA-cleared molecular device, eight (8) | |||
| were negative. | |||
| ** Of the four (4) discordant specimen, three (3) were negative when tested with an | |||
| additional FDA-cleared molecular device. | |||
| Site 1 Performance | |||
| Solana® GAS Assay | Composite Culture Positive | Negative | Total |
| Positive | 60 | 5 | 65 |
| Negative | 1 | 333 | 334 |
| Total | 61 | 338 | 399 |
| 95% CI | |||
| Sensitivity | 60/61 | 98.4% | 91.3% to 99.7% |
| Specificity | 333/338 | 98.5% | 96.6 % to 99.4% |
| Site 2 Performance | |||
| Solana® GAS Assay | Composite Culture Positive | Negative | Total |
| Positive | 69 | 9 | 78 |
| Negative | 1 | 134 | 135 |
| Total | 70 | 143 | 213 |
| 95% CI | |||
| Sensitivity | 69/70 | 98.6% | 92.3% to 99.7% |
| Specificity | 134/143 | 93.7% | 88.5 % to 96.7% |
| Site 3 Performance | |||
| Solana® GAS Assay | Composite Culture Positive | Negative | Total |
| Positive | 29 | 6 | 35 |
| Negative | 0 | 186 | 186 |
| Total | 29 | 192 | 221 |
| 95% CI | |||
| Sensitivity | 29/29 | 100% | 88.3% to 100% |
| Specificity | 186/192 | 96.9% | 93.4 % to 98.6% |
20
-
b. Clinical specificity:
See Section 3a. -
ﻥ Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values:
The overall prevalence of Group A ß-hemolytic Streptococcus in patients tested during this study was 20.7% (224/1081) based on composite bacterial culture and 22.6% (244/1081) based on the Solana™ GAS Assay. All clinical specimens collected during this study were collected between December 2014 and February 2015.
N. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Instrument: Solana™ Instrument
O. System Descriptions:
1. Modes of Operation:
The Solana instrument heats each reaction tube to 64°C. If present, the target sequence is amplified by GAS specific primers and detected by a GAS specific fluorescence probe included in the Reaction Tube. The target probes are labeled with a quencher on one end and a fluorophore on the other end. In addition, the target probes carry a ribonucleic acid. Upon annealing to GAS amplicons, the fluorescence probes are cleaved by RNaseH2 and the fluorescence signal increases due to physical separation of fluorophore from quencher. The Solana instrument measures and interprets the fluorescent signal, using on-board method-specific algorithms. Solana instrument will then report the test results to the user on its display screen, and it can print out the results via a printer.
21
2. Software:
FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:
Yes __________________________________________________________________________________________________________________________________________________________________________ No ___________________________________________________________________________________________________________________________________________________________________________
P. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10, 21 CFR 801.109, and the special controls.