(164 days)
Not Found
No
The device description and performance studies focus on standard real-time PCR technology and data analysis based on fluorescence intensity thresholds, with no mention of AI or ML algorithms for data interpretation or diagnosis.
No.
This device is an in vitro diagnostic test intended to aid in the diagnosis of herpes infection by detecting viral DNA, not to provide therapy or treatment for a disease.
Yes
The product's 'Intended Use' clearly states that it is an "in vitro diagnostic test" and is "intended for use as an aid in diagnosis of herpes infection in symptomatic patients."
No
The device description explicitly mentions reagents, enzymes, probes, and instruments (Sentosa® SX101 and Sentosa® SA201), indicating it is a hardware-based in vitro diagnostic test system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states it is a "qualitative in vitro diagnostic test". It also describes its purpose as detecting and differentiating HSV-1 and HSV-2 DNA from patient samples to aid in the diagnosis of herpes infection. This aligns perfectly with the definition of an in vitro diagnostic device, which is intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details the reagents, enzymes, and process used to analyze biological samples (nucleic acids extracted from swabs) outside of the body. This is characteristic of an in vitro test.
- Clinical Studies: The document describes clinical studies using patient samples to evaluate the performance of the test against a reference method. This is a standard requirement for demonstrating the clinical validity of an IVD.
- Performance Metrics: The document provides key performance metrics like sensitivity and specificity, which are crucial for evaluating the accuracy and reliability of an IVD.
- Predicate Device: The mention of a predicate device (K140198; IMDx HSV-1/2 for Abbott m2000 Assay) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
N/A
Intended Use / Indications for Use
The Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR-based qualitative in vitro diagnostic test for detection and differentiation of Herpes Simplex Virus (HSV-1 and HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in diagnosis of herpes infection in symptomatic patients.
Warning: The Sentosa® SA201 HSV-1/2 PCR Test is not FDA cleared for use with cerebrospinal fluid (CSF). The test is not intended to be used for prenatal screening.
Product codes (comma separated list FDA assigned to the subject device)
OQO
Device Description
The Sentosa® SA201 HSV-1/2 PCR Test is a (4x24) configuration contains reagents and enzymes for specific amplification of a 104 bp (base-pair) fragment of the UL30 gene common to both HSV1 and HSV2, and specific probes for the direct detection and differentiation of HSV1 and HSV2 amplicons, respectively. Pathogen detection by PCR is based on the amplification of specific regions of the pathogen genome. In real-time PCR, the amplified product is detected via fluorescent dyes, which are usually linked to oligonucleotide probes that bind specifically to the target sequences. Real-time monitoring of the fluorescence intensities during a PCR run allows the detection of the accumulating product. Amplification of the targets occurs in three channels: green, orange and red on the Sentosa® SA201. Output is recorded as the increase of fluorescence over time in comparison to background signal. Monitoring the fluorescence intensities during the PCR run allows the detection of the accumulating product without having to re-open the reaction tubes after the PCR run.
The Sentosa® SA201 HSV-1/2 PCR Test workflow starts with extraction of nucleic acids from samples (anogenital or oral swabs) using the Sentosa® SX Virus Total Nucleic Acid Kit on the Sentosa SX101 instrument. Following extraction, the instrument will automatically set up the PCR with the extracted nucleic acids in a 96-well PCR plate. Subsequently, the 96-well PCR plate is sealed and transferred to the Sentosa® SA201 for PCR amplification, followed by data analysis.
The Sentosa® Link facilitates data transfer between the Sentosa® SX101, the Sentosa® SA201 Reporter and existing LIS/LIMS (laboratory information systems) in the clinical lab. The Sentosa SX101 instrument communicates with Sentosa® SA201 thermocycler. This creates a user environment that links the SX101 and the Sentosa® SA201 to facilitate automated workflow to export results in a LIS/LIMS-compatible format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
male and female skin lesions from anogenital or oral sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Analytical sensitivity: The limit of detection (LoD) was assessed for the Sentosa® SA201 HSV-1/2 PCR Test using two strains of HSV-1 (MacIntyre and KOS) and two strains of HSV-2 (MS and G). The LoD is defined as the HSV titer (TCID50/mL) detected with a probability of 95% or greater and was determined by Probit analysis using HSV-1 MacIntyre and HSV-2 MS.
- HSV-1 MacIntyre LoD: 40 TCID50/mL
- HSV-1 KOS LoD: 40 TCID50/mL
- HSV-2 MS LoD: 4 TCID50/mL
- HSV-2 G LoD: 4 TCID50/mL
-
Precision: The study was conducted over a period of five (5) days with three (3) reagent lots, five (5) operators, and four (4) instrument systems at Vela Research Singapore. Each concentration was assayed three (3) times per run for 20 runs, resulting in 60 replicates. The demonstrated agreement with the results being 100% for all tested types, and the %CV being (less than)
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
0
February 1, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vela Diagnostics USA Inc. Donald Henton Dir. Regulatory Affairs North America 353C US Route 46 West Suite 250 Fairfield, New Jersey 07004
Re: K172509
Trade/Device Name: Sentosa SA201 HSV 1/2 Oualitative PCR Test Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: 000 Dated: December 29, 2017 Received: January 4, 2018
Dear Donald Henton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Uwe Scherf -S
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172509
Device Name
Sentosa® SA201 HSV-1/2 PCR Test
Indications for Use (Describe)
Intended Use
The Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR-based qualitative in vitro diagnostic test for detection and differentiation of Herpes Simplex Virus (HSV-1 and HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in diagnosis of herpes infection in symptomatic patients.
Warning: The Sentosa® SA201 HSV-1/2 PCR Test is not FDA cleared for use with cerebrospinal fluid (CSF). The test is not intended to be used for prenatal screening.
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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3
Image /page/3/Picture/0 description: The image contains the logo for Vela Diagnostics. The logo features a stylized human figure with arms raised, connected to a DNA helix in blue and green. To the right of the figure, the word "VELA" is written in large, bold, blue letters. Below "VELA", the word "DIAGNOSTICS" is written in smaller, green letters.
510(k) Summary
Date summary prepared: 1/31/2018
510(k) Submitter/Holder
Vela Diagnostics USA, Inc. 353C US Route 46 West Suite 250 Fairfield, NJ 07004
Contact
Donald Henton Director Regulatory Affairs North America Telephone: 973-369-3578 Fax: 973-521-7077 Email: donald.henton@veladx.com
Name of Device
| Trade Name: | Sentosa® SA201 HSV-1/2 PCR Test |
|---|---|
| Catalog Numbers: | 300216 |
| Common Name: | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Classification Name: | Herpes simplex virus serological assays (21 CFR § 866.3305, Class II, OQO). |
Predicate Device
The Sentosa® SA201 HSV-1/2 PCR Test was compared to and found to be substantially equivalent to the following product of comparable type in commercial distribution:
| Trade Name: | IMDx HSV-1/2 for Abbott m2000 Assay |
|---|---|
| Common Name: | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| 510(k) Number: | K140198 (cleared 05/13/2014) |
| Manufacturer: | Intelligent Medical Devices, Inc. |
4
| Table 1. Sentosa® SA201 HSV-1/2 PCR Test and Predicate Similarities Comparison | ||||
|---|---|---|---|---|
| Item | Device | Predicate | Similarities /
Differences |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Sentosa® SA201 HSV1/2
PCR Test (K172509) | IMDx HSV-1/2 for
Abbott m2000 Assay
(K140198) | |
| Regulation | 21 CFR 866.3305 | 21 CFR 866.3305 | Same |
| Product Code | OQO | OQO | Same |
| Device Class | Class II | Class II | Same |
| Intended use | The Sentosa® SA201
HSV-1/2 PCR Test is a
real-time PCR-based
qualitative in vitro
diagnostic test for
detection and
differentiation of Herpes
Simplex Virus (HSV-1
and HSV-2) DNA from
male and female skin
lesions from anogenital
or oral sites. The test is
intended for use as an aid
in diagnosis of herpes
infection in symptomatic
patients.
Warning: The Sentosa®
SA201 HSV-1/2 PCR
Test is not FDA cleared
for use with
cerebrospinal fluid
(CSF). The test is not
intended to be used for
prenatal screening. | The IMDx HSV-1/2
for Abbott m2000
assay is an in vitro
diagnostic test for the
direct, qualitative
detection and
differentiation of
Herpes Simplex Virus
type 1 (HSV-1) and
type 2 (HSV-2) DNA
from male and female
skin lesions from
anogenital or oral
sites. The test is
intended for use as an
aid in the diagnosis of
HSV infection in
symptomatic patients.
The assay is intended
to be run on the Abbott
m2000 instrument
system.
Warning: The IMDx
HSV-1/2 for Abbott
m2000 assay is not
FDA-cleared for use
with cerebrospinal
fluid (CSF). The assay
is not intended for pre-
natal screening. | The intended use
is the same
except the noted
systems they are
designed to be
run on.
The warning is
the same. |
| Test Principle | Real-time PCR DNA
amplification | Real-time PCR DNA
amplification | Same |
| Assay Results | Qualitative detection
and differentiation of
HSV-1 and HSV-2
DNA | Qualitative detection
and differentiation of
HSV-1 and HSV-2
DNA | Same |
| Sample type | Male and female skin
lesions from anogenital
or oral sites | Male and female skin
lesions from
anogenital or oral sites | Same |
5
Device Description
The Sentosa® SA201 HSV-1/2 PCR Test is a (4x24) configuration contains reagents and enzymes for specific amplification of a 104 bp (base-pair) fragment of the UL30 gene common to both HSV1 and HSV2, and specific probes for the direct detection and differentiation of HSV1 and HSV2 amplicons, respectively. Pathogen detection by PCR is based on the amplification of specific regions of the pathogen genome. In real-time PCR, the amplified product is detected via fluorescent dyes, which are usually linked to oligonucleotide probes that bind specifically to the target sequences. Real-time monitoring of the fluorescence intensities during a PCR run allows the detection of the accumulating product. Amplification of the targets occurs in three channels: green, orange and red on the Sentosa® SA201. Output is recorded as the increase of fluorescence over time in comparison to background signal. Monitoring the fluorescence intensities during the PCR run allows the detection of the accumulating product without having to re-open the reaction tubes after the PCR run.
The Sentosa® SA201 HSV-1/2 PCR Test workflow starts with extraction of nucleic acids from samples (anogenital or oral swabs) using the Sentosa® SX Virus Total Nucleic Acid Kit on the Sentosa SX101 instrument. Following extraction, the instrument will automatically set up the PCR with the extracted nucleic acids in a 96-well PCR plate. Subsequently, the 96-well PCR plate is sealed and transferred to the Sentosa® SA201 for PCR amplification, followed by data analysis.
The Sentosa® Link facilitates data transfer between the Sentosa® SX101, the Sentosa® SA201 Reporter and existing LIS/LIMS (laboratory information systems) in the clinical lab. The Sentosa SX101 instrument communicates with Sentosa® SA201 thermocycler. This creates a user environment that links the SX101 and the Sentosa® SA201 to facilitate automated workflow to export results in a LIS/LIMS-compatible format.
Intended Use
The Sentosa® SA201 HSV-1/2 PCR Test is a real-time PCR-based qualitative in vitro diagnostic test for detection and differentiation of Herpes Simplex Virus (HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in diagnosis of herpes infection in symptomatic patients.
Warning: The Sentosa® SA201 HSV-1/2 PCR Test is not FDA cleared for use with cerebrospinal fluid (CSF). The test is not intended to be used for prenatal screening.
6
Technological Characteristics
The Sentosa® SA201 HSV-1/2 PCR Test contains reagents and enzymes for specific amplification of a 104 bp fragment of UL30 gene common to both HSV1 and HSV2, and specific probes for the direct detection and differentiation of HSV1 and HSV2 amplicons, respectively. Pathogen detection by PCR is based on the amplification of specific regions of the pathogen genome. In real-time PCR, the amplified product is detected via fluorescent dyes, which are usually linked to oligonucleotide probes that bind specifically to the target sequences. Real-time monitoring of the fluorescence intensities during a PCR run allows the detection of the accumulating product. Amplification of the targets occurs in three channels: green, orange and red on the Sentosa" SA201. Output is recorded as the increase of fluorescence over time in comparison to background signal. Monitoring the fluorescence intensities during the PCR run allows the accumulating product without having to re-open the reaction tubes after the PCR run.
The Sentosa SA201 HSV-1/2 PCR Test workflow starts with extraction of nucleic acids from samples (anogenital or oral swabs) using the Sentosa® SX Virus Total Nucleic Acid Kit on the Sentosa® SX101 instrument. Following extraction, the instrument will automatically set up the PCR with the extracted nucleic acids in a 96-well PCR plate. Subsequently, the 96-well PCR plate is sealed and transferred to the Sentosa" SA201 for PCR amplification, followed by data analysis.
Drivers are installed on the Sentosa Link to connect the Sentosa SX101 instrument and the Sentosa SA201 thermocycler. This creates a user environment that links the SX101 and the Sentosa SA201 to facilitate automated workflow to export results in a LIS/LIMS-compatible format.
The Sentosa® SA201 HSV-1/2 PCR Test uses the Sentosa® SX101 hardware and Sentosa® SA201 hardware, along with the associated consumables to operate as an automated sample extraction, PCR setup, amplification and reporting system (referred to as workflow for short).
7
Image /page/7/Figure/0 description: This image describes the sample workflow for the Sentosa SA201 HSV1/2 PCR Test. The workflow begins with an oral or anogenital swab, followed by off-board preparation. The reagents used are the Sentosa SX Virus Total Nucleic Acid Kit (4x24) and the Sentosa SA201 HSV1/2 PCR Test (4x24). The instruments used are the Sentosa SX101 and the Sentosa SA201, and the software used is the Sentosa SX101 software, Sentosa Link, and the Sentosa SA201 Reporter.
Figure 1. Sentosa® SA201 HSV-1/2 PCR Test Workflow Overview.
8
Image /page/8/Figure/0 description: This image is a flowchart describing the steps of a laboratory procedure. The procedure starts with sample preparation, followed by scanning samples using the Sentosa Link software. The Sentosa SX101 software is then launched, and consumables, reagents, controls, and samples are loaded onto the Sentosa SX101. The procedure ends with the Sentosa SA201 Reporter software interpreting the results.
Sentosa® Link reads and displays the results
Figure 2. Sentosa® SA201 HSV-1/2 PCR Test Workflow Flowchart.
9
Performance
Analytical Studies:
- Analytical sensitivity: The limit of detection (LoD) was assessed for the Sentosa® SA201 HSV-1/2 PCR Test using two strains of HSV-1 (MacIntyre and KOS) and two strains of HSV-2 (MS and G). The LoD is defined as the HSV titer (TCID50/mL) detected with a probability of 95% or greater and was determined by Probit analysis using HSV-1 MacIntyre and HSV-2 MS. The results of the analytical sensitivity of the Sentosa SA201 HSV-1/2 PCR Test are summarized in the following table.
| Strain | LoD
(TCID50/mL) |
|-----------------|--------------------|
| HSV-1 MacIntyre | 40 |
| HSV-1 KOS | 40 |
| HSV-2 MS | 4 |
| HSV-2 G | 4 |
| Table 2. Analytical sensitivity - Limit of Detection (LoD) HSV-1 and HSV-2 | ||
|---|---|---|
| ---------------------------------------------------------------------------- | -- | -- |
- Precision: The study was conducted over a period of five (5) days with three (3) reagent lots. five (5) operators, and four (4) instrument systems at Vela Research Singapore. The test materials used in the study included NC, PC, and negative sample, 3xLoD HSV1, 1.5xLoD HSV1, 3xLoD HSV2 and 1.5xLoD HSV2. Each concentration was assayed three (3) times per run for 20 runs, resulting in 60 replicates (three (3) replicates/run x four (4) run/day x five (5) days x one (1) site = 60 replicates). The precision analysis was based on %CV of Ct values, and is presented in Table 3 below. The quality control analysis was based on the mean and standard deviations (SD) of the Ct values. The demonstrated agreement with the results being 100% for all tested types, and the %CV being (less than) 90 | 0/0 | 0/3 | 0/3 | 0/0 | 1/3 | 1/3 |
| 0.0% | 0.0% | 0.0% | 0.0% | 33.3% | 33.3% | |
| TOTAL | 293/1248 | 42/333 | 335/1581 | 430/1573 | 108/405 | 538/1978 |
| 23.5% | 12.6% | 21.2% | 27.3% | 26.7% | 27.2% | |
Table 10. Distribution of samples according to demographics for anogenital lesions as tested by Sentosa® SA201 HSV-1/2 PCR Test
18
| Age
| (years) | HSV-1 | HSV-2 | |||||
|---|---|---|---|---|---|---|---|
| Female | Male | Combined | Female | Male | Combined | ||
| 0 - 10 | 11/25 | 10/28 | 21/53 | 0/25 | 0/29 | 0/54 | |
| 44.0% | 35.7% | 39.6% | 0.0% | 0.0% | 0.0% | ||
| 11 - 20 | 7/13 | 5/18 | 12/31 | 0/13 | 0/18 | 0/31 | |
| 53.8% | 27.8% | 38.7% | 0.0% | 0.0% | 0.0% | ||
| 21 - 30 | 8/40 | 6/26 | 14/66 | 0/40 | 0/26 | 0/66 | |
| 20.0% | 23.1% | 21.2% | 0.0% | 0.0% | 0.0% | ||
| 31 - 40 | 5/23 | 5/16 | 10/39 | 1/24 | 0/16 | 1/40 | |
| 21.7% | 31.3% | 25.6% | 4.2% | 0.0% | 2.5% | ||
| 41 - 50 | 9/19 | 2/6 | 11/25 | 0/19 | 0/6 | 0/25 | |
| 47.4% | 33.3% | 44.0% | 0.0% | 0.0% | 0.0% | ||
| 51 - 60 | 7/25 | 5/9 | 12/34 | 0/25 | 0/9 | 0/34 | |
| 28.0% | 55.6% | 35.3% | 0.0% | 0.0% | 0.0% | ||
| 61 - 70 | 4/18 | 7/14 | 11/32 | 1/18 | 0/14 | 1/32 | |
| 22.2% | 50.0% | 34.4% | 5.6% | 0.0% | 3.1% | ||
| 71 - 80 | 9/13 | 7/14 | 16/27 | 0/13 | 1/15 | 1/28 | |
| 69.2% | 50.0% | 59.3% | 0.0% | 6.7% | 3.6% | ||
| 81 - 90 | 1/3 | 2/4 | 3/7 | 0/3 | 0/4 | 0/7 | |
| 33.3% | 50.0% | 42.9% | 0.0% | 0.0% | 0.0% | ||
| TOTAL | 61/179 | 49/135 | 110/314 | 2/180 | 1/137 | 3/317 | |
| 34.1% | 36.3% | 35.0% | 1.1% | 0.7% | 0.9% |
Table 11. Distribution of samples according to demographics for oral lesions as tested by Sentosa® SA201 HSV-1/2 PCR Test
Positive and Negative Predictive Value: Hypothetical positive and negative predictive values (PPV & NPV) for the Sentosa® SA201 HSV-1/2 PCR Test are shown below. These calculations for hypothetical prevalence are based on overall sensitivity and specificity per sample type from the clinical study results. For HSV-1, these calculations are based upon an overall sensitivity and specificity of 96.90% and 95.82%, respectively, for anogenital swabs and 100.0% and 86.38%, respectively, for oral swabs. For HSV-2, these calculations are based upon an overall sensitivity and specificity of 98.49% and 90.70%, respectively, for anogenital swabs and 66.67% and 99.68%, respectively, for oral swabs.
| Anogenital | Oral | |||||||
|---|---|---|---|---|---|---|---|---|
| Prevalence | ||||||||
| (%) | HSV-1 | HSV-2 | HSV-1 | HSV-2 | ||||
| PPV | NPV | PPV | NPV | PPV | NPV | PPV | NPV | |
| 2 | 32.12% | 99.93% | 17.77% | 99.97% | 13.03% | 100.00% | 80.96% | 99.32% |
| 5 | 54.96% | 99.83% | 35.79% | 99.91% | 27.87% | 100.00% | 91.64% | 98.27% |
| 10 | 72.03% | 99.64% | 54.06% | 99.82% | 44.93% | 100.00% | 95.86% | 96.42% |
| 20 | 85.28% | 99.20% | 72.58% | 99.59% | 64.73% | 100.00% | 98.12% | 92.29% |
| 30 | 90.86% | 98.63% | 81.95% | 99.29% | 75.88% | 100.00% | 98.89% | 87.47% |
| 40 | 93.92% | 97.89% | 87.59% | 98.90% | 83.04% | 100.00% | 99.29% | 81.77% |
| 50 | 95.86% | 96.87% | 91.37% | 98.36% | 88.01% | 100.00% | 99.52% | 74.94% |
Table 12. Prevalence vs hypothetical Predictive Values
19
- HSV-2 oral lesion contrived specimen study: A contrived specimen study was performed to provide additional performance data for detection of HSV-2 in oral samples. A study was performed to test 30 HSV-2-contrived oral lesion samples, along with 15 HSV-1 positive oral lesion samples and 15 HSV-1/HSV-2 negative samples. In the test, all 30 HSV-2-contrived oral lesion samples were identified as HSV-2 positive, and all 15 HSV-1 positive and 15 HSV-1/2 negative samples were correctly identified.
Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.