Immunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-1 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-1 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 and negative results depends on the population's prevalence and the pretest likelihood of HSV-1.

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, immunocompromised patients, or for use at point-of-care facilities.

Device Description

The Elecsys HSV-1 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-1-specific antigens and HSV-1-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-1 IgG immunoassay is intended for the qualitative determination of IgG class antibodies to HSV-1 in human serum and in the presumptive diagnosis of HSV-1 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.

AI/ML Overview

The provided text describes the Elecsys HSV-1 IgG immunoassay (08948844160) and its substantial equivalence to a legally marketed predicate device (Elecsys HSV-1 IgG, K120625). However, the document does not contain specific acceptance criteria, reported device performance figures, or detailed study information such as sample sizes, data provenance, ground truth establishment methods, or the results of comparative effectiveness studies.

The document primarily focuses on the regulatory aspects of the device, its intended use, and the technological updates made to improve biotin and streptavidin tolerance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document.
Reported Device Performance: Not provided in the document.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not provided.
Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided.

4. Adjudication method for the test set:

Not provided.

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:

This is an immunoassay, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study as typically understood for AI in medical imaging would not be applicable, and no such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is a standalone immunoassay device. The document mentions: "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." This suggests standalone performance, but no specific study or performance metrics are detailed in this document.

7. The type of ground truth used:

Not explicitly stated for performance evaluation. For HSV-1 serological assays, ground truth is typically established through a combination of confirmatory methods (e.g., Western blot, PCR, or clinical diagnosis based on symptoms and other tests), but the document does not specify this for its validation.

8. The sample size for the training set:

Not provided.

9. How the ground truth for the training set was established:

Not provided.

Summary of Available Information (with placeholders for missing data):

Information Type	Details / Status
Acceptance Criteria	Not explicitly stated in the provided text.
Reported Device Performance	Not provided in the provided text.
Sample Size (Test Set)	Not provided.
Data Provenance (Test Set)	Not provided.
Number of Experts for Ground Truth (Test Set) & Qualifications	Not provided.
Adjudication Method (Test Set)	Not provided.
MRMC Comparative Effectiveness Study	No. This is an immunoassay, not an AI-assisted interpretation device in the context of typical MRMC studies.
Standalone Performance Study	The device operates independently by software comparing signals to cutoff values. While the document implies standalone functionality, specific study results or metrics for standalone performance are not provided.
Type of Ground Truth Used	Not explicitly stated. Typically, for serological assays, this would involve confirmatory testing methods (e.g., Western blot) or well-characterized clinical diagnosis.
Sample Size (Training Set)	Not provided.
How Ground Truth for Training Set was Established	Not provided.
Purpose of Technological Updates	To improve biotin tolerance from < 70 ng/mL to ≤ 1200 ng/mL and to reduce streptavidin interference. Achieved by adding a biotin-depleting agent and a streptavidin interference reducing agent to the reagents.
Intended Use	In vitro qualitative determination of IgG class antibodies to HSV-1 in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. Intended for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. For use on cobas e immunoassay analyzers. Not FDA-cleared for screening blood/plasma donors. Performance not established for pediatric population, neonates, immunocompromised patients, or point-of-care facilities. The updated assay includes a note that "The test results may not determine the state of active lesions or associated disease manifestations, particularly for primary infection."
Predicate Device (and its clearance number)	Elecsys HSV-1 IgG (K120625)

Summary

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October 12, 2022

Roche Diagnostics Cynthia Aker Regulatory Affairs Principal 9115 Hague Road PO Box 50416 Indianapolis, Indiana 46250

Re: K220923

Trade/Device Name: Elecsys HSV-1 IgG (08948844160) 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

Device Name

Elecsys HSV-1 IgG (08948844160)

Indications for Use (Describe)

lmmunoassay for the in vitro qualitative determination of IgG class antibodies to HSV-1 in human serum and lithium-hepain 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-1 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 and negative results depends on the population's prevalence and the pretest likelihood of HSV-1.

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, immunocompromised patients, or for use at point-of-care facilities.

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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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-1 IgG (08948844160)
Common Name	Herpes simplex virus serological assays
Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Regulation Number	866.3305
Product Code	MXJ
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)			Product Code
K120625	Elecsys HSV-1 IgG			MXJ
Device Description Summary			21 CFR 807.92(a)(4)
The Elecsys HSV-1 IgG immunoassay makes use of a sandwich test principle using biotinylated recombinant HSV-1-specific antigens and HSV-1-specific recombinant antigens labeled with a ruthenium complex. The Elecsys HSV-1 IgG immunoassay is intended for the

The and HSI qualitative determination of lgG class antibodies to HSV-1 in human serum and in the presumptive diagnosis of HSV-1 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-1 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-1 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 results depends on the population's prevalence and the pretest likelihood of HSV-1.

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 pediatic population, neonates, immunocompromised patients, or for use at point-of-care facilities.

Indications for Use Comparison

Elecsys HSV-1 lgG (updated assay Mat. No. 08948844160) is substantially equivalent to Elecsys HSV-1 lgG, cleared under K120625.

The intended use of Elecsys HSV-1 IgG was updated to remove analyzers that are no longer supported for use with Roche assays. It 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-1 IgG did not change from the predicate device.

Technological Comparison

Roche Diagnostics has updated the current Elecsys HSV-1 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)(6)

21 CFR 807.92(a)(5)

Regulation Number and Section

§ 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).