(267 days)
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No
The summary describes a standard ELISA assay and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) test intended for the qualitative detection of human IgG antibodies to HSV-2, which aids in the presumptive diagnosis of HSV-2 infection. It does not provide any treatment or therapy.
Yes
Explanation: The "Intended Use" section explicitly states that the device is "intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum" and is "an aid in the presumptive diagnosis of HSV-2 infection". This directly indicates its diagnostic purpose.
No
The device description clearly states it is a solid-phase enzyme-linked immunoassay (ELISA) performed in microwells, indicating it is a physical laboratory test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use Only."
- Nature of the Test: The device is an enzyme-linked immunosorbent assay (ELISA) that detects antibodies in human serum. This is a classic example of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide diagnostic information.
- Intended Use: The intended use is to aid in the presumptive diagnosis of HSV-2 infection by detecting antibodies in human serum. This directly aligns with the purpose of an IVD.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.
A positive result indicates previous exposure to Type 2 Herpes Simplex Virus.
Product codes
MYF
Device Description
The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.
The principle involves diluted patient samples incubated in antigen-coated wells. HSV Type 2 antibodies, if present, are immobilized. Residual sample is washed, and enzyme-labeled antibodies to human IgG (conjugate) are added. If IgG antibodies to HSV-2 are present, the conjugate is immobilized. Residual conjugate is washed, and substrate is added. In the presence of substrate, it converts to a yellow end-product that is read photometrically.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Sexually active individuals and expectant mothers. Not established for pediatric patients.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Precision Testing:
- Six serum specimens (2 negative, 4 positive) and the SeraQuest HSV Type 2 Specific IgG Positive and Negative Controls were assayed in triplicate, on three separate occasions.
- Performed at Quest International and at two external independent laboratories.
- The results are summarized in Table 2, showing Means, Standard Deviations and Coefficients of Variation calculated from SeraQuest Index values.
Specificity Testing:
- A cross-reactivity study was performed using samples from various disease states and other potentially cross-reacting agents.
- Samples were determined positive for IgG antibodies against taxonomically related viruses and other related pathogens by other legally marketed devices.
- Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections.
- Only samples that tested negative for Type 2 HSV antibody by the legally marketed device were included.
- Results are shown in Table 3.
Interference Testing:
- The effects of icterus, hemolysis, hyperdicidemia and hyperproteinemia on test results were examined.
- Samples that were negative, weakly positive and moderately positive for antibodies to Type 2 HSV were tested with and without elevated levels of hemoglobin, glucose, cholesterol, globulin, unconjugated bilirubin, conjugated bilirubin, human albumin, and ascorbic acid.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Precision Testing
- Study Type: Precision Study (Intra-assay, Inter-assay, Inter-laboratory)
- Sample Size: 27 replicates for each of 6 serum specimens (2 negative, 4 positive) and 2 controls (Positive and Negative).
- Key Results: Mean Index, Standard Deviation (SD), and Coefficient of Variation (CV%) were calculated for all samples across intra-assay, inter-assay, inter-laboratory, and total variability. CV% ranged from 5.6 to 48.2%.
2. Specificity Testing
- Study Type: Cross-reactivity study
- Sample Size: 99 samples in total (HSV 1 IgG: 9, CMV IgG: 11, VZV EBNA IgG: 14, VZV VCA IgG: 17, VZV IgG: 21, Measles IgG: 19, Rubella IgG: 18, Toxoplasma IgG: 6, Syphilis IgG: 4, Human Papilloma Virus: 7, Chlamydia trachomitis: 8, Neisseria gonorrhea: 7).
- Key Results: 0/99 samples tested positive in the SeraQuest HSV Type 2 Specific IgG Test, except for 1/8 Chlamydia trachomitis samples. This indicates high specificity against common interfering substances and other infections.
3. Interference Testing
- Study Type: Interference study
- Sample Size: Not explicitly stated, samples were "negative, weakly positive and moderately positive for antibodies to Type 2 HSV".
- Key Results: No significant interference was observed in the presence of abnormally elevated levels of hemoglobin, glucose, cholesterol, globulin, unconjugated bilirubin, conjugated bilirubin, human albumin, and ascorbic acid. Grossly hemolyzed, icteric or lipemic samples are not recommended for testing.
4. Comparison With The Predicate Device
- Study Type: Comparative study with predicate device (Commercial HSV 2 Immunoblot test).
- Sample Size:
- 164 serum samples from sexually active adults.
- 242 serum samples from expectant mothers (198 in first trimester, 19 in second, 25 in third).
- Key Results:
- Sexually Active Adults (Table 4):
- Sensitivity: 91.8% (95% C.I.: 82.2 to 96.5)
- Specificity: 94.2% (95% C.I.: 87.9 to 97.3)
- Expectant Mothers (Table 5):
- Sensitivity: 98.9% (95% C.I.: 93.8 to 99.8)
- Specificity: 99.4% (95% C.I.: 96.4 to 99.9)
- Sexually Active Adults (Table 4):
5. CDC Panel Results
- Study Type: Performance evaluation with a masked, well-characterized serum panel from the CDC.
- Sample Size: 100 sera (30 HSV-2 IgG positive and 70 HSV-2 IgG negative).
- Key Results: The SeraQuest HSV Type 2 Specific IgG test demonstrated 100% total agreement with the CDC consensus results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sexually Active Adults (in comparison with a commercial HSV 2 Immunoblot test):
- Sensitivity: 91.8% (95% C.I.: 82.2 to 96.5)
- Specificity: 94.2% (95% C.I.: 87.9 to 97.3)
Expectant Mothers (in comparison with a commercial HSV 2 Immunoblot test):
- Sensitivity: 98.9% (95% C.I.: 93.8 to 99.8)
- Specificity: 99.4% (95% C.I.: 96.4 to 99.9)
CDC Panel Results (Percent Agreement with the CDC Panel):
- 100% total agreement with the CDC consensus results.
Predicate Device(s)
A commercial, legally marketed HSV 1 and 2 Immunoblot IgG test.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
Quest International, Inc. Dr. David J. Kiefer, Ph.D. Director, Research and Development 8127 NW 29th Street Miami, FL 33122
Re: K152353
Trade/Device Name: SeraQuest HSV Type 2 Specific IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF Dated: April 14, 2016 Received: April 14, 2016
Dear Dr. Kiefer:
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
1
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 Part 801), 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
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Indications for Use
510(k) Number (if known) K152353
Device Name SeraOuest HSV Type 2 Specific IgG
Indications for Use (Describe)
- Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.
The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.
-
For In Vitro Diagnostic Use Only.
-
A positive result indicates previous exposure to Type 2 Herpes Simplex Virus.
| 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)
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5. 510k Summary
510(k) Summary
| Applicant: | Quest International, Inc.
8127 NW 29th Street
Doral, FL. 33122 |
|------------------------|----------------------------------------------------------------------|
| Registration No. | 1061839 |
| Contact Person: | David J. Kiefer, Ph.D. |
| Telephone: | 305 592-6991 |
| Telefax: | 305 592-6834 |
| Device: | SeraQuest® HSV Type 2 Specific IgG |
| Medical Device Group: | In vitro diagnostic |
| Device Classification: | Class 2 |
Catalogue Number: 01-420
Description:
The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values. The following table shows the interpretation of results:
| Index | Result | Interpretation |
|---|---|---|
| $\leq$ 0.9 | Negative | No HSV-2 IgG antibodies detected. Patient is presumed not to |
| have had a previous HSV-2 infection. | ||
| 0.9 |