(50 days)
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No
The device description and performance studies describe a standard ELISA assay, which is a biochemical test, not a software-based technology. There is no mention of AI, ML, or any computational analysis beyond basic calculations for index values.
No
Explanation: This device is an in vitro diagnostic (IVD) assay designed to detect antibodies to HSV-1 in human serum, aiding in the diagnosis of infection. It does not provide any treatment or therapeutic benefit to the patient.
Yes
This device is an in vitro diagnostic (IVD) test, specifically an ELISA, intended for the qualitative detection of human IgG antibodies to HSV-1 in serum. Its stated purpose is to "aid in the presumptive diagnosis of HSV-1 infection," which is a diagnostic function.
No
The device is an in vitro diagnostic (IVD) test that uses an ELISA assay, which is a laboratory-based wet chemistry method involving physical reagents and equipment, not solely software.
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 living body to provide information about a person's health status.
- Intended Use: The intended use is to aid in the presumptive diagnosis of HSV-1 infection by detecting antibodies in serum. This aligns with the purpose of IVDs, which are used to diagnose diseases or other conditions.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 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-1 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 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.
Product codes
MXJ
Device Description
The SeraQuest® HSV Type 1 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 IqG antibodies which are directed against HSV 1 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 1 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 |
|---|---|---|
| = 1.0 | Positive | IgG antibody to HSV-1 detected. |
Notes:
- A single positive result only indicates previous immunologic exposure: the level of antibody response may not be used to determine active infection or disease stage.
- When equivocal results are obtained, another specimen should be obtained ten to fourteen days later, and tested in parallel with the initial specimen. If the second specimen is also equivocal, the patient is negative for primary or recent infection, and equivocal for antibody status. If the second sample is positive, the patient can be considered to have previous experience with HSV-1 infection.
- Values obtained with different manufacturer's assay methods may not be used interchangeably. The magnitude of the reported IgG index value cannot be correlated to an endpoint titer. The magnitude of results above the cut-off is not an indicator of total antibody present.
Principle:
Diluted patient samples are incubated in antigen-coated wells. HSV Type 1 antibodies, if present in the patient sample, are immobilized in the wells by binding to the antigen. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to HSV-1 are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the substrate is added and incubated. In the presence of the conjugate, the substrate is converted to a yellow end-product which 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
The test is indicated for sexually active individuals and expectant mothers. The performance of this assay has not been 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision Testing: Six serum specimens (2 negative, 1 equivocal and 3 positive) and the SeraQuest HSV Type 1 Specific IgG Positive and Negative Controls, were assayed in triplicate, on three separate occasions, at Quest International and at two external independent laboratories. The results summarized in Table 2 show the Means, Standard Deviations and Coefficients of Variation.
- Specificity Testing: A cross-reactivity study was performed using samples from various disease states and other potentially cross-reacting agents. These samples were determined to be positive for IgG antibodies directed against taxonomically related viruses and other related pathogens by other legally marketed devices, and were negative for Type 1 HSV antibody by a legally marketed device. Results are shown in Table 3.
- Interference Testing: The effects of icterus, hemolysis, hyperglycemia, hyperlipidemia and hyperproteinemia on test results were examined. Samples that were negative, weakly positive and moderately positive for antibodies to Type 1 HSV were tested with and without the addition of elevated levels of various potential interfering substances. No significant interference was observed.
- Comparison with The Predicate Device:
- Study 1 (Sexually Active Adults): One hundred and sixty-four serum samples from sexually active adults submitted for HSV serology to a clinical laboratory in the Southeastern United States were prospectively collected, masked, archived, and tested using the SeraQuest HSV Type 1 Specific IgG test and a commercial HSV 1 Immunoblot test. Results are shown in Table 4.
- Study 2 (Expectant Mothers): Two hundred and forty-two serum samples from expectant mothers submitted for HSV serology to clinical laboratories in the Northeastern and Southeastern United States were prospectively collected, masked, archived, and tested using the SeraQuest HSV Type 1 Specific IgG test and a legally marketed, HSV 1 Immunoblot test. 198 (82%) were from the first trimester, 19 (8%) from the second, and 25 (10%) from the third. Results are shown in Table 5.
- CDC Panel Results: The SeraQuest HSV Type 1 Specific IgG test was used in-house to test the CDC serum panel for HSV serology assays, consisting of 46 HSV-1 IgG positive and 54 HSV-1 IgG negative samples. Results are shown in Table 6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Comparison with Predicate Device (Sexually Active Adults) - Table 4:
- Sensitivity: 92.3% (95% C.I.: 85.0 to 96.2)
- Specificity: 91.7% (95% C.I.: 83.2 to 96.2)
Comparison with Predicate Device (Expectant Mothers) - Table 5:
- Sensitivity: 93.3% (95% C.I.: 87.3 to 96.6)
- Specificity: 89.4% (95% C.I.: 87.1 to 93.7)
CDC Panel Results - Table 6:
- For CDC HSV 1 Result Positive (46 samples): 42 Positive, 2 Equivocal, 2 Negative.
- For CDC HSV 1 Result Negative (54 samples): 0 Positive, 1 Equivocal, 53 Negative.
Predicate Device(s)
Focus HerpeSelect® 1 and 2 Immunoblot IgG, K000238
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2016
QUEST INTERNATIONAL, INC DAVID J. KIEFER, PH.D. DIRECTOR RESEARCH AND DEVELOPMENT 8127 NW 29TH STREET MIAMI FL 33122
Re: K162276
Trade/Device Name: SeraQuest HSV Type 1 Specific IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: II Product Code: MXJ Dated: August 10, 2016 Received: August 12, 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
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) K162276
Device Name
SeraQuest® HSV Type 1 Specific IgG
Indications for Use (Describe)
For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 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-1 infection. The predictive value of a positive result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 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.
| 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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510(k) Summary
| 510(k) Number: | K162276 |
|---|---|
| Purpose for Submission: | New Device |
| Type of Test: | Enzyme linked immunosorbent assay (ELISA) |
| Measurand: | IgG Antibody to Herpes Simplex Virus-1 (HSV-1) |
| Applicant: | Quest International, Inc. |
| 8127 NW 29th Street | |
| Doral, FL. 33122 | |
| Contact Person: | David J. Kiefer, Ph.D. |
| Telephone: | 305 592-6991 |
| Telefax: | 305 592-6834 |
| Device: | SeraQuest® HSV Type 1 Specific IgG |
Requlatory Information:
-
- Regulation section: Herpes simplex virus serological assays 21 CFR§866.3305
-
- Classification: Class II
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- Product code: MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, HSV-1)
-
- Panel: Microbiology (83)
Cataloque Number: 01-410
Intended Use:
For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 1 Specific IgG assay is an enzymelinked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 1 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-1 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-1 infection in the population and the pre-test likelihood of HSV-1 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.
Description:
The SeraQuest® HSV Type 1 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA), which is performed in microwells, at room temperature, and in three thirty minute
4
incubations. The test detects IqG antibodies which are directed against HSV 1 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 1 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-1 IgG antibodies detected. Patient is presumed not to have had a previous HSV-1 infection. |
| 0.9 |