(163 days)
The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection.
The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing.
The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.
Not Found
This document describes the FDA's decision to clear the Zeus ELISA HSV gG-2 IgG Test System, not a study report detailing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided text.
However, I can extract what is implied about the regulatory context and intended use, which informs the type of studies typically required for such devices.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided as the document is an FDA clearance letter, not a study report. It does not contain specific acceptance criteria values (e.g., sensitivity, specificity thresholds) or the reported performance data from a clinical study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe the test set size, its provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. The document does not describe how ground truth was established, nor the number or qualifications of experts. Given that this is an in-vitro diagnostic device for serological testing, the "ground truth" would likely be established through a combination of other established testing methods rather than expert consensus on images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. The document does not discuss adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable and cannot be provided. This is an in-vitro diagnostic device (ELISA test) for detecting antibodies, not an imaging device intended for interpretation by human readers, nor does it involve AI assistance for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied as 'yes' for the device itself. The device, an ELISA test system, operates as a standalone diagnostic tool to detect antibodies. It's a laboratory test, not an AI algorithm. Its performance is measured directly, not in conjunction with human interpretation for improvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided explicitly, but typically for serological tests: Ground truth for serological assays like this often involves a composite reference standard, which can include multiple established laboratory tests (e.g., Western Blot, viral culture, PCR, or other highly sensitive and specific serological assays).
8. The sample size for the training set
- Cannot be provided. The document does not mention a training set, as it's an ELISA assay, not a machine learning algorithm that requires supervised training data.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable as explained above.
Summary based on the provided document:
The provided document is an FDA 510(k) clearance letter for the Zeus ELISA HSV gG-2 IgG Test System. It indicates that the device has been found "substantially equivalent" to legally marketed predicate devices, allowing its commercialization. The letter itself does not contain the detailed clinical study data, including acceptance criteria or performance metrics, that would have been submitted by the manufacturer to the FDA for review.
The primary information available is:
- Device Name: Zeus ELISA HSV gG-2 IgG Test System
- Indications for Use: Qualitative detection of type-specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum for aiding in the presumptive diagnosis of HSV-2 infection in sexually active individuals or pregnant women.
- Limitations: Not intended for donor screening or self-testing. Performance not established for pediatric population, neonates, or immunocompromised patients.
- Regulatory Class: Class II
- Product Code: MYF
- Regulatory Pathway: 510(k) (substantial equivalence)
To obtain the specific acceptance criteria and detailed study data, one would typically need to consult the 510(k) summary submitted by Zeus Scientific, Inc. to the FDA, which is usually publicly available on the FDA's website after clearance, or the device's Instructions For Use (IFU)/package insert. These documents would detail the specific studies performed (e.g., sensitivity, specificity, reproducibility, interference studies) and the results that demonstrated substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Zeus Scientific, Inc. c/o Ewa K. Nadolczak Manager, Clinical Affairs 200 Evans Way Branchburg, NJ 08876
MAY 2 0 2011
Re: K103603
Trade/Device Name: Zeus ELISA HSV gG-2 IgG Test System Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF Dated: April 13, 2011 Received: April 14, 2011
Dear Ms. Nadolczak:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
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Page 2 – Ewa K. Nadolczak
will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Uwe Schuf Ar.
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K103603
Device Name: ZEUS ELISA HSV gG-2 IgG Test System Indications for Use:
The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection.
The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing.
The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Uve Sch
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103603
§ 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).