(87 days)
No
The device description and performance studies focus on standard real-time PCR technology and data analysis based on fluorescent signal detection and cycle threshold (Ct) values. There is no mention of AI or ML algorithms being used for data processing, interpretation, or diagnosis.
No.
The device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of HSV infection by detecting viral DNA, not to treat or cure the condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients." This indicates its purpose is to help clinicians diagnose a medical condition.
No
The device is an in vitro diagnostic (IVD) kit that includes reagents and is performed on specific hardware (QIAsymphony SP/AS instrument, Rotor-Gene Q MDx) with accompanying software. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay...". It also describes its use for the "direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection." This clearly indicates it's used to test samples taken from the human body outside of the body to provide information for diagnosis.
- Device Description: The description further reinforces this by detailing how the assay works on samples (extraction, PCR amplification, detection) and mentions it's an "in vitro PCR assay".
- Performance Studies: The performance studies involve testing human samples (genital and oral lesions) and comparing the results to a reference method (ELVIS viral culture), which is typical for validating an IVD.
- Predicate Device: The mention of a "Predicate Device" (K100336; Eragen Biosciences MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used to demonstrate substantial equivalence for new IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The artus® HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection.
The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.
Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.
Product codes (comma separated list FDA assigned to the subject device)
000
Device Description
The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro PCR assay for the qualitative detection and differentiation of nucleic acids encoding the Glycoprotein D and UL30 genes isolated from HSV-1 and HSV-2 DNA present in genital or oral lesions from male and female patients. Samples are extracted and prepared for PCR using the QIAsymphony SP/AS instrument with the QIAsymphony DSP Virus/Pathogen Mini Kit. Amplification and detection are carried out using the artus HSV-1/2 QS-RGQ MDx Kit with the Rotor-Gene O MDx (RGO MDx) and Rotor-Gene AssayManager software. The presence of a HSV-1 or HSV-2 target sequence is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes. The amplification cycle at which fluorescent signal is detected by the RGQ MDx is inversely proportional to the HSV-1 and/or HSV-2 target concentration present in the original specimen. A plasmid construct containing DNA unrelated to HSV-1 and HSV-2 is introduced into each specimen during sample preparation to serve as an internal control. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional. In addition, the positive control functions as a process control, to demonstrate that sample preparation has proceeded correctly during the run.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
genital or oral vesicular lesions
Indicated Patient Age Range
Not Found. Oral samples report
§ 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
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 stylized image of an eagle with three human profiles incorporated into its design. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
QIAGEN KIMBERLY MAPP, Ph.D. MANAGER, REGULATORY AFFAIRS 1201 CLOPPER ROAD GAITHERSBURG MD 20878
December 19, 2014
Re: K142738
Trade/Device Name: artus® HSV-1/2 QS-RGQ MDx Kit Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: II Product Code: 000 Dated: September 23, 2014 Received: September 23, 2014
Dear Dr. Mapp:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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/Resourcesfor You/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.
Uwe Scherf -S for
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) K142738
Device Name artus® HSV-1/2 QS-RGQ MDx Kit
Indications for Use (Describe)
The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection.
The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.
Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Page 1 of 17
510(k) SUMMARY
General Information
| Submitted by: | QIAGEN
19300 Germantown Road
Germantown, MD 20874 |
|------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Kimberly Mapp, Ph.D.
Manager, Regulatory Affairs
1201 Clopper Road
Gaithersburg, MD 20878 |
| | Phone: 301.944.7817
Fax: 240.686.3847
Email: kimberly.mapp@qiagen.com |
| Date Prepared: | November 24, 2014 |
| Device Name: | artus ® HSV-1/2 QS-RGQ MDx Kit |
| Trade Name: | artus ® HSV-1/2 QS-RGQ MDx Kit |
| Common Name: | Herpes Simplex Virus detection assay |
| Classification: | Class II |
| Predicate Device | |
| Manufacturer | Product Name | 510(k) No. |
|---|---|---|
| Eragen Biosciences | MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit | K100336 |
Device Description
The artus HSV-1/2 QS-RGQ MDx Kit is an in vitro PCR assay for the qualitative detection and differentiation of nucleic acids encoding the Glycoprotein D and UL30 genes isolated from HSV-1 and HSV-2 DNA present in genital or oral lesions from male and female patients. Samples are extracted and prepared for PCR using the QIAsymphony SP/AS instrument with the QIAsymphony DSP Virus/Pathogen Mini Kit. Amplification and detection are carried out using the artus HSV-1/2 QS-RGQ MDx Kit with the Rotor-Gene O MDx (RGO MDx) and Rotor-Gene AssayManager software. The presence of a HSV-1 or HSV-2 target sequence is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The
4
amplification cycle at which fluorescent signal is detected by the RGQ MDx is inversely proportional to the HSV-1 and/or HSV-2 target concentration present in the original specimen. A plasmid construct containing DNA unrelated to HSV-1 and HSV-2 is introduced into each specimen during sample preparation to serve as an internal control. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional. In addition, the positive control functions as a process control, to demonstrate that sample preparation has proceeded correctly during the run.
Intended Use
The artus HSV-1/2 OS-RGO MDx Kit is an in vitro real-time PCR DNA amplification assay performed on the QIAsymphony RGQ MDx system for the direct qualitative detection and differentiation of herpes simplex virus (HSV-1 and HSV-2) DNA in genital or oral vesicular lesions from male and female patients suspected of HSV infection.
The assay is intended for use as an aid in diagnosis of HSV infection in symptomatic patients.
Warning: The artus HSV-1/2 QS-RGQ MDx Kit is not FDA-cleared for use with cerebrospinal fluid (CSF) or for prenatal screening.
Comparison of the artus® HSV-1/2 QS-RGQ MDx Kit and the Predicate Device
The artus HSV-1/2 QS-RGQ MDx Kit is substantially equivalent to the predicate device:
- K100336: Eragen Biosciences MultiCode®-RTx Herpes Simplex Virus 1 & 2 Kit
Similarities and differences between the artus HSV-1/2 QS-RGQ MDx Kit and the predicate device are shown in Table 1.
5
Table 1: Comparison of the artus HSV-1/2 QS-RGQ MDx Kit with the predicate device
| Characteristic | Device | Predicate |
|---|---|---|
| Name | artus® HSV-1/2 QS-RGQ MDx Kit | Eragen Biosciences MultiCode®- RTx Herpes Simplex Virus 1 & 2 Kit |
| Similarities | ||
| Intended Use | The artus HSV-1/2 QS-RGQ | |
| MDx Kit is an in vitro real-time | ||
| PCR DNA amplification assay | ||
| performed on the QIAsymphony | ||
| RGQ MDx system for the direct | ||
| qualitative detection and | ||
| differentiation of herpes simplex | ||
| virus (HSV-1 and HSV-2) DNA | ||
| in genital or oral vesicular lesions | ||
| from male and female patients | ||
| suspected of HSV infection. | The MultiCode®-RTx Herpes | |
| Simplex Virus 1 & 2 Kit is a | ||
| polymerase chain reaction | ||
| (PCR)-based qualitative in vitro | ||
| diagnostic test for the detection | ||
| and typing of herpes simplex | ||
| virus (HSV1&2) DNA in | ||
| vaginal lesions. It is indicated | ||
| for use in the detection and | ||
| typing of HSV-1 or HSV-2 in | ||
| vaginal lesion swab specimens | ||
| from symptomatic female | ||
| patients as an aid in the | ||
| diagnosis of genital herpes | ||
| infection. | ||
| The assay is intended for use as | ||
| an aid in diagnosis of HSV | ||
| infection in symptomatic patients. | ||
| Warning: The artus HSV-1/2 QS- | ||
| RGQ MDx Kit is not FDA-cleared for use with cerebrospinal | ||
| fluid (CSF) or for prenatal | ||
| screening. | Warning: The device is not | |
| FDA cleared for the use with | ||
| cerebral spinal fluid (CSF) or | ||
| any lesions other than vaginal. | ||
| The assay is not intended to be | ||
| used for male penile specimens, | ||
| for prenatal screening, or | ||
| females under the age of 18 | ||
| years. | ||
| Assay Targets | HSV-1 | |
| HSV-2 | HSV-1 | |
| HSV-2 | ||
| Amplification | ||
| and Detection | ||
| Technology | Real-time PCR DNA | |
| amplification | Real-time PCR DNA | |
| amplification | ||
| Assay Controls | Positive Control, Negative | |
| Control and Internal Control | ||
| included in the kit. | Positive Control, Negative | |
| Control and Internal Control | ||
| included in the kit. | ||
| Differences | ||
| Specimen Type | Male and female genital or oral | |
| herpetic lesions | Female vaginal lesions |
6
Performance Characteristics - Non-Clinical Studies
Analytical Sensitivity (Limit of Detection)
The limit of detection (LoD) was assessed for the artus HSV-1/2 QS-RGQ MDx Kit using 2 strains of HSV-1 (MacIntyre and Isolate #15 from Zeptometrix™ Corporation. (ZMC)) and two strains of HSV-2 (MS and Isolate #2 from Zeptometrix™ Corporation). The LoD is defined as the HSV titer (TCID95% CI | | | | |
| Sensitivity – 96.9% (93/96) | 91.2% – 98.9% | | | |
| Specificity – 91.1% (377/414) | 87.9% – 93.5% | | | |
| Positive Predictive Value – 71.5% | 63.3% – 78.6% | | | |
| Negative Predictive Value – 99.2% | 97.7% – 99.7% | | | |
| Prevalence – 19.0% | 16.0% – 22.0% | | | |
Table 13: HSV-2 Results for Genital Samples (N=510)
*32 discordant specimens (artus HSV-1/2 QS-RGQ MDx Positive, ELVIS Negative) reported were analyzed by alternative PCR followed by bi-directional sequencing and the result was that 27 out of 32 were positive for HSV-2, agreeing with the artus HSV-1/2 QS-RGQ MDx result. The remaining 5 samples were not available for discordant analysis.
** 3 discordant specimens (artus HSV-1/2 QS-RGQ MDx Negative, ELVIS Positive) reported were analyzed by alternative PCR followed by bi-directional sequencing and the result was that all were negative for HSV-2, agreeing with the artus HSV-1/2 QS-RGQ MDx result.
| HSV-1 | ELVIS | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| artus HSV-1/2 QS- | ||||
| RGQ MDx Kit | POS | 45 | 19* | 64 |
| NEG | 3** | 85 | 88 | |
| TOTAL | 48 | 104 | 152 | |
| 95% CI | ||||
| Sensitivity – 93.8% (45/48) | 83.2% – 97.9% | |||
| Specificity – 81.7% (85/104) | 73.2% - 88.0% | |||
| Positive Predictive Value – 70.3% | 58.2% - 80.1% | |||
| Negative Predictive Value – 96.6% | 90.5% - 98.8% | |||
| Prevalence – 32.0% | 25.0% - 39.0% |
Table 14: HSV-1 Results for Oral Samples (N=152)
- 19 discordant specimens (artus HSV-1/2 QS-RGQ MDx Positive, ELVIS Negative) reported were analyzed by alternative PCR followed by bi-directional sequencing and the result was that 13 out of 19 were positive for HSV-1, agreeing with the artus HSV-1/2 QS-RGQ MDx result. **2 discordant specimens (artus HSV-1/2 QS-RGQ MDx Negative, ELVIS Positive) reported were analyzed by alternative PCR followed by bi-directional sequencing and the result was that 2 out of 2 were negative for HSV-1, agreeing with the artus HSV-1/2 QS-RGQ MDx result. The remaining 1 specimen was unavailable for discordant analysis testing.
18
Page 16 of 17
| Table 15: HSV-2 Results for Oral Samples (N=152) | ||||
|---|---|---|---|---|
| HSV-2 | ELVIS | |||
| POS | NEG | Total | ||
| artus HSV-1/2 QS- | ||||
| RGQ MDx Kit | POS | 0 | 0 | 0 |
| NEG | 0 | 152 | 152 | |
| TOTAL | 0 | 152 | 152 | |
| 95% CI | ||||
| Sensitivity – N/A | N/A | |||
| Specificity – 100.0% (152/152) | 97.5% – 100.0% | |||
| Positive Predictive Value – N/A | N/A | |||
| Negative Predictive Value – 100.0% | 97.5% – 100.0% | |||
| Prevalence – 0.0% | 0.0% – 2.0% |
Table 15: HSV-2 Results for Oral Samples (N-152)
Table 16: HSV-1 Mucocutaneous Samples (N=281)
| HSV-1 | ELVIS | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| artus HSV-1/2 QS- | ||||
| RGQ MDx Kit | POS | 62 | 23 | 85 |
| NEG | 4 | 192 | 196 | |
| TOTAL | 66 | 215 | 281 | |
| 95% CI | ||||
| Sensitivity – 93.9% (62/66) | 85.4% – 97.6% | |||
| Specificity – 89.3% (192/215) | 84.5% – 92.8% | |||
| Positive Predictive Value – 72.9% | 62.7% – 81.2% | |||
| Negative Predictive Value – 98.0% | 94.9% – 99.2% | |||
| Prevalence – 23.0% | 19.0% – 29.0% |
| Table 17: HSV-2 Mucocutaneous Samples (N=320) | |||||||
|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | ----------------------------------------------- | -- | -- | -- |
| HSV-2 | ELVIS | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| POS | 37 | 16 | 53 | |
| artus HSV-1/2 QS- | ||||
| RGQ MDx Kit | NEG | 2 | 265 | 267 |
| TOTAL | 39 | 281 | 320 | |
| 95% CI | ||||
| Sensitivity – 94.9% (37/39) | 83.1% – 98.6% | |||
| Specificity – 94.3% (265/281) | 91.0% – 96.5% | |||
| Positive Predictive Value – 69.8% | 56.5% – 80.5% | |||
| Negative Predictive Value – 99.3% | 97.3% – 99.8% | |||
| Prevalence – 12.0% | 9.0% – 16.0% |
19
HSV-2 Oral Retrospective Sample Study and Contrived Sample Study:
A retrospective study was conducted using oral samples for HSV2 detection. A total of 38 oral retrospective specimens were tested with the artus HSV-1/2 QS-RGQ MDx assay and ELVIS HSV ID and D3 Typing Test System. There were no HSV-2 positive specimens detected in 38 oral specimens.
A contrived specimen study was performed to provide additional performance data for detection of HSV-2 in oral samples. A panel of seventy (70) individual samples consisting of 15 HSV-1/2 negative oral samples, 10 HSV-1 positive oral samples and 45 HSV-1/2 negative oral samples spiked with HSV-2 at a concentration from 3X LoD to 1000X LoD and tested with the artus HSV-1/2 QS-RGQ MDx Kit. The HSV-1 positive oral samples and HSV-1/2 negative oral samples obtained from the method comparison study were used to make the panel. All samples were randomized and blinded to the operator prior to testing. HSV-2 was detected in all 45 contrived samples at all concentrations tested, supporting the claim for detection of HSV-2 in oral samples by the artus HSV-1/2 QS-RGQ MDx Kit.