(195 days)
lmmunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
This test is not FDA-cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients or for use at point-of-care facilities.
The Elecsys HSV-2 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-2-specific antigens and HSV-2-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-2 IgG immunoassay is intended for the qualitative determination of lgG class antibodies to HSV-2 in human serum and in the presumptive diagnosis of HSV-2 infection. It is intended for use on the cobas e immunoassay analyzers. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.
The Elecsys HSV-2 IgG (08948887160) device is an immunoassay for the qualitative determination of IgG class antibodies to HSV-2. The study involved a comparison against a predicate device (K121895).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity thresholds) that were required for clearance or the corresponding reported device performance values in a quantitative manner. Instead, it focuses on demonstrating substantial equivalence to a predicate device and improved technical characteristics.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)" section is where such data would typically be found, but it is not expanded upon in the provided text. The submission describes technological improvements to biotin tolerance and streptavidin interference, which are performance characteristics.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed within the non-clinical and/or clinical test summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not specify the number of experts used to establish the ground truth for the test set or their qualifications. For an immunoassay, the ground truth would typically be established by a reference method or a panel of samples with confirmed HSV-2 status, rather than expert interpretation of images or clinical cases.
4. Adjudication Method
The provided text does not specify any adjudication method. For an immunoassay, adjudication might not be relevant in the same way as for subjective diagnostic tasks like image interpretation, as the result is typically a quantitative measurement converted to a qualitative outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, as this device is an immunoassay and does not involve human readers interpreting cases in the same way an imaging diagnostic device would. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Performance
The device itself is a standalone immunoassay. Its performance is measured directly through its ability to detect HSV-2 IgG antibodies. While the document mentions "cobas e immunoassay analyzers" for its use, the performance described would implicitly be the standalone performance of the assay on these automated platforms. The provided text does not provide quantitative standalone performance metrics such as sensitivity and specificity.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the provided text. However, for an immunoassay for antibodies, the ground truth for test samples would typically be established by:
- Reference methods: Such as Western blot, more sensitive PCR, or another highly validated immunoassay.
- Clinical diagnosis and follow-up: Including a history of recurrent genital lesions confirmed by viral culture or PCR.
- Well-characterized seroconversion panels: For sensitivity studies.
Given that this is an immunoassay for IgG antibodies to HSV-2, the ground truth would likely involve confirmed HSV-2 infection status based on established laboratory methods and/or clinical presentation.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set. Immunoassays are typically "trained" during their development and optimization phases using numerous characterized samples to establish appropriate cut-offs and ensure performance.
9. How the Ground Truth for the Training Set Was Established
The provided text does not specify how the ground truth for the training set was established. Similar to the test set, it would have involved established laboratory reference methods and/or clinical confirmation of HSV-2 status. For an immunoassay, training involves optimizing reagent concentrations, reaction conditions, and setting cut-off values using panels of known positive and negative samples.
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October 12, 2022
Roche Diagnostics Cynthia Aker Regulatory Affairs Principal 9115 Hague Road PO Box 50416 Indianapolis, Indiana 46250
Re: K220924
Trade/Device Name: Elecsys HSV-2 IgG (08948887160) Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF Dated: March 29, 2022 Received: March 31, 2022
Dear Cynthia Aker:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maria Garcia, Ph.D. Assistant Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Elecsys HSV-2 IgG (08948887160)
Indications for Use (Describe)
lmmunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
This test is not FDA-cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients or for use at point-of-care facilities.
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
Prepared on: 2022-09-26
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | Roche Diagnostics | |
| Applicant Address | 9115 Hague Road PO Box 50416 Indianapolis IN 46250 United States | |
| Applicant Contact Telephone | 1-463-336-2138 | |
| Applicant Contact | Mrs. Cynthia Aker | |
| Applicant Contact Email | cynthia.aker@roche.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Elecsys HSV-2 IgG (08948887160) | |
| Common Name | Herpes simplex virus serological assays | |
| Classification Name | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | |
| Regulation Number | 866.3305 | |
| Product Code | MYF | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K121895 | Elecsys HSV-2 IgG | MYF |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The Elecsys HSV-2 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-2-specific antigens and HSV-2-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-2 IgG immunoassay is intended for the
The and HSI qualitative determination of lgG class antibodies to HSV-2 in human serum and in the presumptive diagnosis of HSV-2 infection. It is intended for use on the cobas e immunoassay analyzers. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction
product of the sample with the signal of the cutoff value previously obtained by calibration.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
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lmmunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection. The predictive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
This test is not FDA-cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediation, neonates, or immunocompromised patients or for use at point-of-care facilities.
Indications for Use Comparison
Elecsys HSV-2 lgG (updated assay Mat. No. 0894887160) is substantially equivalent to Elecsys HSV-2 lgG, deared under K121895.
The intended use of Elecsys HSV-2 lgG was updated to remove analyzers that are no longer supported for use with Roche assays. The intended use was also updated to add the following sentence: "The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection."
The indications for use of the Elecsys HSV-2 IgG did not change from the predicate device.
Technological Comparison
Roche Diagnostics has updated the current Elecsys HSV-2 lgG assay in order to improve the biotin tolerance from < 70 ng/mL to ≤ 1200 ng/mL and to reduce streptavidin interference. A technical solution was implemented by adding an of the reagents, which allows depletion of biotin samples by binding free biotin, and by adding a streptavidin interference reducing agent to enhance the streptavidin tolerance. No other technological characteristics were changed. The information submitted in this Premarket Notification supports a substantial equivalent decision.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
§ 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).