(191 days)
Not Found
No
The device description and performance studies focus on standard PCR technology and statistical analysis of results, with no mention of AI or ML algorithms for data interpretation or decision making.
No.
The device is an in vitro diagnostic test for detecting HSV-1/2 DNA, which is used for diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV-1) and Herpes Simplex Virus Type-2 (HSV-2) DNA... The test is intended for use as and in the diagnosis of anogenital HSV infection in symptomatic patients." This explicitly labels it as a diagnostic test.
No
The device description clearly outlines a PCR-based in vitro diagnostic test that utilizes reagents, probes, controls, and a specific hardware instrument (Cepheid SmartCycler® II Dx instrument) to perform the assay. This involves significant hardware and chemical components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The AnyplexTM II HSV-1/2 Assay is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV-1) and Herpes Simplex Virus Type-2 (HSV-2) DNA from female skin lesions from anogenital sites."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Anyplex™ II HSV-1/2 Assay is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV-1) and Herpes Simplex Virus Type-2 (HSV-2) DNA from female skin lesions from anogenital sites. The test is intended for use as and in the diagnosis of anogenital HSV infection in symptomatic patients.
WARNING: The Anyplex™ II HSV-1/2 Assay is not indicated for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening.
Product codes (comma separated list FDA assigned to the subject device)
OQO
Device Description
The Anyplex™ II HSV-1/2 Assay uses PCR to generate amplified product from HSV-1 and HSV-2 present in clinical specimens. The presence of HSV-1 and/or HSV-2 target DNA is indicated by the fluorescent signal generated through the use of fluorescently-labeled oligonucleotide probes (duplex Catcher) on the Cepheid SmartCycler® II Dx instrument. The probes do not generate a signal unless they are specifically bound to the amplified product. A preparation of HSV-1 and HSV-2 plasmids is included as the positive control in the Anyplex™ II HSV-1/2 Assay. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional, and discriminate the validity of the run. In addition, the positive control functions as a process control, demonstrating that sample preparation has proceeded correctly during the run. An internal control (IC) is also included in the assay kit. The IC is added to each sample specimen during sample preparation, and is also used to create a Blank Negative Control by adding a set amount to viral transport media to serve as an extraction control. In addition, the RNase-free water is used to create the Negative Control by adding a set volume to the prepared master mix. Users are instructed to include all three controls, Positive, Negative, and Blank Negative Control with each test run.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
female skin lesions from anogenital 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 Performance
Precision/Repeatability:
A precision study was conducted in-house by testing 5 different panels consisting of HSV-1/2 Negative, HSV-1 Low Positive (1X LoD), HSV-1 High Positive (10X LoD), HSV-2 Low Positive (1X LoD) and HSV-2 High Positive (10X LoD). All panels were tested twice per day for twenty days by one operator. Samples were tested in triplicates for each run (for a total of 600 data points for the 40 runs).
Key results are summarized in Table 2: Precision Study Average Ct Values, showing 100% agreement with expected results for all panel members, except for Negative control where Ct is not applicable.
- HSV-1 Low Positive (1X LoD): 100.00% (120/120) agreement, Avg. Ct 42.93, SD Ct 0.75, %CV Ct 1.74%
- HSV-1 High Positive (10X LoD): 100.00% (120/120) agreement, Avg. Ct 40.32, SD Ct 0.71, %CV Ct 1.76%
- HSV-2 Low Positive (1X LoD): 100.00% (120/120) agreement, Avg. Ct 41.31, SD Ct 1.06, %CV Ct 2.56%
- HSV-2 High Positive (10X LoD): 100.00% (120/120) agreement, Avg. Ct 38.19, SD Ct 0.51, %CV Ct 1.34%
- Negative: 100.00% (120/120) agreement
Precision/Reproducibility Results
Reproducibility studies were performed at three sites (one internal and two external clinical sites) using 3 lots of the reagent kits. Each test site tested one lot of the reagent kit. The test panel of seven members was prepared blinded and randomized and tested for five (5) days nonconsecutive days by two operators with each operator running the panel, in triplicate, once a day. Variables in the reproducibility study included between run-to-run, operator-to-operator, site-to-site and lot-to-lot.
Key results are summarized in Table 3: Reproducibility Study Summary.
- HSV-1 High-Positive (3X LoD): 100.0% agreement (90/90) across all 3 sites combined, Avg. Ct 36.1 (2.6% CV).
- HSV-1 Low-Positive (1X LoD): 96.67% agreement (87/90) across all 3 sites combined, Avg. Ct 39.6 (2.6% CV).
- HSV-1 High-Negative (
§ 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).
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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 features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three human profiles facing right, representing health and well-being. 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
August 17, 2015
SEEGENE C/O FRAN WHITE, REGULATORY CONSULTANT MDC ASSOCIATES, LLC 180 CABOT STREET BEVERLY MA 01915
Re: K142156
Trade/Device Name: Anyplex™ II HSV-1/2 Assay Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes Simplex Virus Nucleic Acid Amplification Assay Regulatory Class: II Product Code: OQO Dated: February 10, 2015 Received: February 11, 2015
Dear Dr. White:
This letter corrects our substantially equivalent letter of February 13, 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, 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
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 regulation (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" (21CFR 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,
Stephen J. Lovell -S for
Uwe Scherf. M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142156
Device Name AnyplexTM II HSV-1/2 Assay
Indications for Use (Describe)
The AnyplexTM II HSV-1/2 Assay is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV-1) and Herpes Simplex Virus Type-2 (HSV-2) DNA from female skin lesions from anogenital sites. The test is intended for use as and in the diagnosis of anogenital HSV infection in symptomatic patients.
WARNING: The AnyplexTM II HSV-1/2 Assay is not indicated for use with cerebrospinal fluid (CSF). The assay 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
510(k) Summary
| Date of Summary: | February 9, 2015 |
|---|---|
| Product Name | Anyplex™ II HSV-1/2 Assay |
| Sponsor | Seegene |
| Taewon Building, 91 Ogeum-ro Songpa-Gu | |
| Seoul, South Korea, 138-050 | |
| Correspondent | MDC Associates, LLC |
| Fran White, Regulatory Consultant | |
| 180 Cabot Street | |
| Beverly, MA 01915 | |
| Device Identification | |
| Trade or Proprietary Name: | Anyplex™ II HSV-1/2 Assay |
| Common or Usual Name: | HSV-1/2 Assay |
| Product Code: | OQO |
| Regulation Section: | 21 CFR 866.3305 |
| Product Classification: | Class II |
Intended Use
The Anyplex 110 II HSV-1/2 Assay is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV-1) and Herpes Simplex Virus Type-2 (HSV-2) DNA from female skin lesions from anogenital sites. The test is intended for use as an aid in the diagnosis of anogenital HSV infection in symptomatic patients.
WARNING: The Anyplex™ II HSV-1/2 Assay is not indicated for use with cerebrospinal fluid (CSF). The assay is not intended to be used for prenatal screening.
Device Description
The Anyplex™ II HSV-1/2 Assay uses PCR to generate amplified product from HSV-1 and HSV-2 present in clinical specimens. The presence of HSV-1 and/or HSV-2 target DNA is indicated by the fluorescent signal generated through the use of fluorescently-labeled oligonucleotide probes (duplex Catcher) on the Cepheid SmartCycler® II Dx instrument. The
4
probes do not generate a signal unless they are specifically bound to the amplified product. A preparation of HSV-1 and HSV-2 plasmids is included as the positive control in the Anyplex™ II HSV-1/2 Assay. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional, and discriminate the validity of the run. In addition, the positive control functions as a process control, demonstrating that sample preparation has proceeded correctly during the run. An internal control (IC) is also included in the assay kit. The IC is added to each sample specimen during sample preparation, and is also used to create a Blank Negative Control by adding a set amount to viral transport media to serve as an extraction control. In addition, the RNase-free water is used to create the Negative Control by adding a set volume to the prepared master mix. Users are instructed to include all three controls, Positive, Negative, and Blank Negative Control with each test run.
Substantial Equivalency
The Anyplex™ II HSV-1/2 Assay is substantially equivalent to the IMDx HSV-1/2 for Abbott m2000 assay. Table 1 compares the characteristics of the Anyplex™ II HSV-1/2 Assay (New Device) and the IMDx HSV-1/2 for Abbott m2000 assay (Predicate Device).
| Similarities | ||
|---|---|---|
| Characteristic | IMDx HSV-1/2 for | |
| Abbott m2000 Assay | ||
| (Predicate Device) | Anyplex™ II HSV-1/2 Assay | |
| (New Device) | ||
| 510(k) | K140198 | K142156 |
| Regulation | 21 CFR 866.3305 | 21 CFR 866.3305 |
| Product Code | OQO | OQO |
| Device Class | Class II | Class II |
| Intended use | 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 viruses 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 cerebral spinal | The Anyplex™ II HSV-1/2 Assay is a real-time polymerase chain reaction (PCR)-based in vitro diagnostic test intended for the qualitative detection and differentiation of Herpes Simplex Virus Type-1 (HSV1) and Herpes Simplex Virus Type-2 (HSV2) DNA from female skin lesions from anogenital sites. The test is intended for use as an aid in the diagnosis of anogenital HSV infection in symptomatic patients.
WARNING: The Anyplex™ II HSV-1/2 Assay is not indicated for use with cerebrospinal fluid (CSF). The |
Table 1: Substantial Equivalence
5
| Similarities | ||||||
|---|---|---|---|---|---|---|
| Characteristic | IMDx HSV-1/2 for | |||||
| Abbott m2000 Assay | ||||||
| (Predicate Device) | Anyplex™ II HSV-1/2 Assay | |||||
| (New Device) | ||||||
| fluid (CSF) or for pre-natal screening. | assay is not intended to be used for | |||||
| prenatal screening. | ||||||
| Test Principle | Real-time PCR DNA amplification | Real-time PCR DNA amplification | ||||
| Assay Results | Qualitative detection and | |||||
| differentiation of HSV-1 and HSV-2 | Qualitative detection and | |||||
| differentiation of HSV-1 and HSV-2 | ||||||
| Differences | ||||||
| Characteristic | IMDx HSV-1/2 for | |||||
| Abbott m2000 Assay | ||||||
| (Predicate Device) | Anyplex™ II HSV-1/2 Assay | |||||
| (New Device) | ||||||
| Instrumentation | Sample extraction and real-time PCR | |||||
| amplification/detection using the | ||||||
| Abbott m2000 system. | Real-time PCR | |||||
| amplification/detection using the | ||||||
| Cepheid SmartCycler II DX system. | ||||||
| Extraction | ||||||
| Method | Automated on Abbott m2000 system | Manual extraction using the QIAGEN | ||||
| QIAamp® DNA Mini Kit | ||||||
| Detection | ||||||
| Method | Double-labeled (fluorophore and | |||||
| quencher) hydrolysis probes. | ||||||
| Measures increase in assay | ||||||
| fluorescence with each PCR cycle. | Double-labeled (fluorophore and | |||||
| quencher) duplex Catcher. Measures | ||||||
| increase in assay fluorescence with | ||||||
| each PCR cycle. | ||||||
| Sample type | Male and female skin lesions from | |||||
| anogenital or oral sites | Female skin lesions from anogenital | |||||
| sites only |
Performance Characteristics
Analytical Performance
Precision/Repeatability:
A precision study was conducted in-house by testing 5 different panels consisting of HSV-1/2 Negative, HSV-1 Low Positive (1X LoD), HSV-1 High Positive (10X LoD), HSV-2 Low Positive (1X LoD) and HSV-2 High Positive (10X LoD). All panels were tested twice per day for twenty days by one operator. Samples were tested in triplicates for each run (for a total of 600 data points for the 40 runs).
6
| Panel Member | Level | Agreement
with expected
results | 95%
Confidence
Interval | Avg. Ct | SD Ct | %CV Ct |
|------------------------|---------|---------------------------------------|-------------------------------|---------|-------|--------|
| HSV-1 Low
Positive | 1X LoD | 100.00%
(120/120) | 96.90% -
100.00% | 42.93 | 0.75 | 1.74% |
| HSV-1 High
Positive | 10X LoD | 100.00%
(120/120) | 96.90% -
100.00% | 40.32 | 0.71 | 1.76% |
| HSV-2 Low
Positive | 1X LoD | 100.00%
(120/120) | 96.90% -
100.00% | 41.31 | 1.06 | 2.56% |
| HSV-2 High
Positive | 10X LoD | 100.00%
(120/120) | 96.90% -
100.00% | 38.19 | 0.51 | 1.34% |
| Negative | N/A | 100.00%
(120/120) | 96.90% -
100.00% | N/A | N/A | N/A |
Table 2: Precision Study Average Ct Values
Mean: Average Ct of positive results only.
Precision/Reproducibility Results
Reproducibility studies were performed at three sites (one internal and two external clinical sites) using 3 lots of the reagent kits. Each test site tested one lot of the reagent kit. The test panel of seven members was prepared blinded and randomized and tested for five (5) days nonconsecutive days by two operators with each operator running the panel, in triplicate, once a day. Variables in the reproducibility study included between run-to-run, operator-to-operator, site-tosite and lot-to-lot.
Table 3 below shows the Percent (%) Agreement and Average of Ct for each site as well as the Total (%) agreement and Average of Ct for all 3 sites combined.
7
Table 3: Reproducibility Study Summary
| Site 1 | Site 2 | Site 3 | All 3 sites Combined | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Panel Member | Concentration | % Agreement | |||||||
| Agreement | |||||||||
| with expected | |||||||||
| result | Avg. Ct | ||||||||
| (%CV) | % Agreement | ||||||||
| Agreement with | |||||||||
| expected result | Avg. Ct | ||||||||
| (%CV) | % Agreement | ||||||||
| Agreement | |||||||||
| with expected | |||||||||
| result | Avg. Ct | ||||||||
| (%CV) | % Agreement | ||||||||
| Agreement | |||||||||
| with expected | |||||||||
| result | Avg. Ct | ||||||||
| (%CV) | |||||||||
| HSV-1 High- | 3X LoD | 100.0% | |||||||
| 30/30 | 36.4 | ||||||||
| (2.0%) | 100.0% | ||||||||
| 30/30 | 35.9 | ||||||||
| (2.6%) | 100.0% | ||||||||
| 30/30 | 36.1 | ||||||||
| (2.9%) | 100.0% | ||||||||
| 90/90 | 36.1 | ||||||||
| (2.6%) | |||||||||
| Positive* | |||||||||
| HSV-1 Low- | 1X LoD | 100.0% | |||||||
| 30/30 | 39.9 | ||||||||
| (2.2%) | 90.0% | ||||||||
| 27/30 | 39.8 | ||||||||
| (3.3%) | 100.0% | ||||||||
| 30/30 | 39.2 | ||||||||
| (1.7%) | 96.67% | ||||||||
| 87/90 | 39.6 | ||||||||
| (2.6%) | |||||||||
| Positive* | |||||||||
| HSV-1 High- |