(85 days)
Not Found
No
The summary describes a standard immunoassay technology and does not mention any AI or ML components in the device description or performance studies.
No.
This device is an in vitro diagnostic assay used for the qualitative detection of specific IgG antibodies to HSV-2. It aids in the presumptive diagnosis of HSV-2 infection, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "to aid in the presumptive diagnosis of HSV-2 infection." This indicates its role in identifying a medical condition.
No
The device is an in vitro diagnostic assay that uses physical reagents and an automated instrument (ARCHITECT i System) to perform a chemiluminescent immunoassay. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum and plasma." This involves testing biological samples (serum and plasma) outside of the body to aid in diagnosis.
- Device Description: The description details an "automated, two-step immunoassay" using "chemiluminescent microparticle immunoassay (CMIA) technology" and lists components like "Reagent," "Calibrator," and "external Controls." These are all characteristic of in vitro diagnostic devices used in laboratory settings.
- Performance Studies: The document describes extensive performance studies conducted on human samples (serum and plasma) to evaluate the assay's accuracy, precision, and specificity. This is a requirement for IVD devices to demonstrate their reliability for diagnostic purposes.
- Clinical Agreement Study: The clinical agreement study compares the device's performance to a "composite comparator method of 3 commercially available anti-HSV-2 IgG assays," which are themselves IVD devices. This comparison is done to demonstrate the device's clinical utility in a diagnostic context.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K000238) indicates that this device is being compared to a previously cleared or approved IVD device, a common practice in the regulatory pathway for new IVDs.
All of these factors clearly indicate that the ARCHITECT HSV-2 IgG assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin, and lithium heparin plasma separator tubes) on the ARCHITECT i System.
The ARCHITECT HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to 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 a reactive or nonreactive result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.
NOTE: The performance of the ARCHITECT HSV-2 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunocompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.
Product codes
MYF
Device Description
The ARCHITECT HSV-2 IgG assay is an automated, two-step immunoassay for the qualitative detection of IgG antibodies to HSV-2 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.
The kit contains different components: Reagent (microparticles, conjugate and assay diluent), Calibrator, and external Controls (reactive and nonreactive).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Sexually active adults or expectant mothers.
NOTE: The performance of the ARCHITECT HSV-2 IgG assay has not been established for use in the pediatric population.
Intended User / Care Setting
Not Found
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
CDC Panel Agreement: The CDC Performance Panel was obtained from the Centers for Disease Control and Prevention (CDC) and tested using the ARCHITECT HSV-2 IgG assay. The CDC panel consisted of 2 aliquots each of 50 serum samples with unknown HSV-2 status for a total of 100 blind characterized samples. The results were submitted to the CDC for data evaluation.
Cut-off: A study to establish the ARCHITECT HSV-2 IgG assay cutoff was performed using 505 serum samples (271 reactive, 228 nonreactive, and 6 equivocal for HSV-2 IgG antibodies).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Specimen Collection Types: Sixty-one (61) sets of unique serum samples paired with samples collected in serum separator tube (SST), dipotassium EDTA plasma, lithium-heparin plasma and lithium heparin plasma separator tube (PST) were evaluated with the ARCHITECT HSV-2 IgG assay on the ARCHITECT i2000SR instrument to support equivalent performance using each of these specimen types. The samples were analyzed by linear regression using serum as comparator matrix.
Precision:
a. Within-Laboratory Precision (20-Day): A within-laboratory precision study was performed using 3 lots of the ARCHITECT HSV-2 IgG reagents, 3 lots of the ARCHITECT HSV-2 IgG Calibrator, 1 lot of the ARCHITECT HSV-2 IgG Controls, and 1 ARCHITECT i2000SR instrument. Sample size: 240-244 for various panels.
b. Within-Laboratory Precision (12-Day): An additional within-laboratory precision study was conducted using samples with higher analyte levels, using 2 lots of the ARCHITECT HSV-2 IgG reagents, 1 lot of the ARCHITECT HSV-2 IgG Calibrator, and 1 ARCHITECT i2000SR instrument. Sample size: 96 for various panels.
Reproducibility: A reproducibility study was conducted at 3 testing sites using one lot of the ARCHITECT HSV-2 IgG reagents, 1 lot of the ARCHITECT HSV-2 IgG Calibrator, 1 lot of the ARCHITECT HSV-2 IgG controls, and 1 ARCHITECT i2000SR instrument, over 5 days. Sample size: 90 for various panels.
Analytical Specificity:
Interference: Evaluated for potential interference of endogenous and exogenous (drugs) substances using HSV-2 IgG nonreactive and low reactive samples. Results: Less than 10% absolute difference for reactive HSV-2 IgG samples and less than 0.10 S/CO absolute difference for nonreactive HSV-2 IgG samples were observed at specified concentrations of potentially interfering substances.
Potential Cross-reactivity: Evaluated using specimens from individuals containing antibodies to other microorganisms or with medical conditions unrelated to HSV-2 infection. Examples of false reactive results: 1 out of 8 with Anti-dsDNA autoantibodies, 1 out of 12 with elevated IgG, 1 out of 10 Gardnerella vaginalis, 1 out of 13 Human herpesvirus-6 IgG, 2 out of 10 Human herpesvirus-8 IgG, 2 out of 13 Parvovirus B19 IgG, 1 out of 10 RF, 1 out of 10 Toxoplasma gondii.
CDC Panel Agreement: The ARCHITECT HSV-2 IgG assay demonstrated 100% Positive Percent Agreement (PPA) for reactive samples (30/30) and 97.14% Negative Percent Agreement (NPA) for nonreactive samples (68/70) when evaluating the CDC performance panel.
Cut-off: A Receiver-Operating Characteristic (ROC) curve analysis was performed. The optimal cut-off of 1.00 S/CO was selected and validated in the method comparison study.
Carry-Over: The ARCHITECT HSV-2 IgG assay is not susceptible to within-assay sample carryover.
Expected Values: Clinical performance was evaluated with 915 samples collected prospectively from individuals from the intended use population (670 females, 245 males, median age 35, range 14 to 99 years). Testing performed at 3 clinical testing sites.
Clinical Agreement Study: A multi-center clinical study was conducted to evaluate the clinical performance. PPA and NPA were determined by comparing to a composite comparator method of 3 commercially available anti-HSV-2 IgG assays (2 out of 3 approach). Total 915 specimens (sexually active individuals and pregnant females) collected prospectively in the United States and tested at 3 independent external laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
CDC Panel Agreement:
Positive Percent Agreement (PPA): 100% (30/30)
Negative Percent Agreement (NPA): 97.14% (68/70)
Clinical Agreement Study:
Sexually Active Population:
PPA = 96.54% (223/231); 95% CI= 93.32% to 98.24%
NPA = 96.90% (375/387); 95% CI= 94.66% to 98.22%
Pregnant Population:
PPA = 95.12% (78/82); 95% CI = 88.12% to 98.09%
NPA = 98.60% (212/215); 95% CI = 95.98% to 99.52%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Build Correspondence
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Date: February 12, 2025
Biokit, S.A. Janna Puig Regulatory Affairs Manager Av. Can Montcau 7 Lliçà d'Amunt, Barcelona, 08186 Spain
Re: K243575
Trade/Device Name: ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes Simplex Virus Serological Assays Regulatory Class: Class II Product Code: MYF Dated: November 19, 2024 Received: November 19, 2024
Dear Janna Puig:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation reguires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
2
Sincerely,
Image /page/2/Picture/3 description: The image contains two lines of text. The first line reads "JORGE L." and the second line reads "MUNOZ-S". The text is in a simple, sans-serif font and is displayed in black against a white background. The text appears to be a name.
Digitally signed by JORGE L. MUNOZ -S Date: 2025.02.12 15:35:57 -04'00'
Jorge Munoz, Ph.D. Deputy Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243575
Device Name ARCHITECT HSV-2 IgG
Indications for Use (Describe)
The ARCHITECT HSV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of specific IgG antibodies to herpes simplex virus type 2 (HSV-2) in human serum (collected in serum and serum separator tubes) and plasma (collected in dipotassium EDTA, lithium heparin plasma separator tubes) on the ARCHITECT i System.
The ARCHITECT HSV-2 IgG assay is to be used for testing sexually active adults or expectant mothers to aid in the presumptive diagnosis of HSV-2 infection. The test results may not determine the state of active lessociated disease manifestations, particularly for primary infection. The predictive value of a reactive or nonreactive result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.
NOTE: The performance of the ARCHITECT HSV-2 IgG assay has not been established for use in the pediatric population, for neonatal screening, or for testing immunosompromised or immunosuppressed patients. The assay has not been FDA cleared or approved for screening blood or plasma donors.
| 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) | ||||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||||
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| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. |
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) SUMMARY
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| 1. Submitter's
Information | Biokit, S.A.
Av. Can Montcau, 7
Lliçà d'Amunt 08186
Barcelona (Spain) |
| ------------------------------- | -------------------------------------------------------------------------------- |
|---|
| 2. Contact Person | Janna Puig, Regulatory Affairs Manager
Phone: +34 93 860 90 00
Email: jpuig@werfen.com |
| ------------------- | ---------------------------------------------------------------------------------------------- |
|---|
| 3. Preparation Date | 2025-02-12 |
|---|---|
| --------------------- | ------------ |
| 4. Device Trade
| Name | ARCHITECT HSV-2 IgG |
|---|---|
| -------------------------- | --------------------- |
| 5. Regulatory
| Information | Regulation Number | 21 CFR 866.3305 |
|---|---|---|
| Regulation Description | Herpes simplex virus | |
| serological assays. | ||
| Classification | Class II Special | |
| Controls | ||
| Product Code | MYF | |
| Classification Panel | Microbiology |
5
| 7. Indications for
Use / Intended
Use | The ARCHITECT HSV-2 IgG assay is a
chemiluminescent microparticle immunoassay
(CMIA) used for the qualitative detection of
specific IgG antibodies to herpes simplex virus
type 2 (HSV-2) in human serum (collected in
serum and serum separator tubes) and plasma
(collected in dipotassium EDTA, lithium heparin,
and lithium heparin plasma separator tubes) on
the ARCHITECT i System.
The ARCHITECT HSV-2 IgG assay is to be used
for testing sexually active adults or expectant
mothers to 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 a
reactive or nonreactive result depends on the
prevalence of HSV-2 infection in the population
and the pre-test likelihood of HSV-2 infection.
NOTE: The performance of the ARCHITECT HSV-
2 IgG assay has not been established for use in
the pediatric population, for neonatal screening,
or for testing immunocompromised or
immunosuppressed patients. The assay has not
been FDA cleared or approved for screening blood
or plasma donors. |
| --------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| 8. Device
Description | The ARCHITECT HSV-2 IgG assay is an
automated, two-step immunoassay for the
qualitative detection of IgG antibodies to HSV-2
in human serum and plasma using
chemiluminescent microparticle immunoassay
(CMIA) technology. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The kit contains different components: Reagent
(microparticles, conjugate and assay diluent),
Calibrator, and external Controls (reactive and
nonreactive). |
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T
| COMPARISON PREDICATE | ||
|---|---|---|
| Item | Predicate | New Device |
| Trade Names | HSV-1 & HSV-2 | |
| Differentiation Immunoblot | ||
| IgG | ARCHITECT HSV-2 IgG, | |
| ARCHITECT HSV-2 IgG | ||
| Calibrator, ARCHITECT HSV- | ||
| 2 IgG Controls | ||
| 510K no. | K000238 | K243575 |
| Manufacturer | MRL Diagnostics | |
| Cypress, CA 90630 -USA | Abbott Ireland Diagnostics | |
| Division | ||
| Finisklin Business Park, | ||
| Sligo, Ireland | ||
| Similarities | ||
| Intended use | MRL Diagnostics' HSV-1 & | |
| HSV-2 Differentiation | ||
| Immunoblot IgG test is | ||
| intended for qualitatively | ||
| detecting the presence or | ||
| absence of human IgG class | ||
| antibodies to HSV-1 and | ||
| HSV-2 in human sera. | ||
| The test is indicated for | ||
| testing sexually active | ||
| adults or expectant mothers | ||
| for aiding in the | ||
| presumptive diagnosis of | ||
| HSV-1 and HSV-2 infection. | ||
| The predictive value of a | ||
| positive or negative result | ||
| depends on the population's | ||
| prevalence and pretest | ||
| likelihood of HSV-1 and | ||
| HSV-2 infection. The | ||
| performance of this assay | ||
| has not been established for | ||
| use in a pediatric | ||
| population, for neonatal | ||
| screening, for testing of | ||
| immunocompromised | ||
| patients, for use by a point | The ARCHITECT HSV-2 IgG | |
| assay is a chemiluminescent | ||
| microparticle immunoassay | ||
| (CMIA) used for the | ||
| qualitative detection of | ||
| specific IgG antibodies to | ||
| herpes simplex virus type 2 | ||
| (HSV- 2) in human serum | ||
| (collected in serum and | ||
| serum separator tubes) and | ||
| plasma (collected in | ||
| dipotassium EDTA, lithium | ||
| heparin, and lithium heparin | ||
| plasma separator tubes) on | ||
| the ARCHITECT i System. | ||
| The ARCHITECT HSV-2 IgG | ||
| assay is to be used for | ||
| testing sexually active adults | ||
| or expectant mothers to 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 a reactive | ||
| or nonreactive result |
7
| | of care facility or for use
with automated equipment. | depends on the prevalence
of HSV-2 infection in the
population and the pre-test
likelihood of HSV-2 infection.
NOTE: The performance of
the ARCHITECT HSV-2 IgG
assay has not been
established for use in the
pediatric population, for
neonatal screening, or for
testing immunocompromised
or immunosuppressed
patients. The assay has not
been FDA cleared or
approved for screening
blood or plasma donors. | | |
|--------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Measurand | Human IgG class antibodies
to HSV-1 and HSV-2 | Human IgG antibodies to
HSV-2 | | |
| Regulation
Section | 21 CFR 866.3305 | Same | | |
| Classification | Class II Special Controls | Same | | |
| Assay Type | Qualitative | Same | | |
| Differences | | | | |
| Product Code | LGC | MYF | | |
| Technology | Nitrocellulose immunoblot | Chemiluminescent
immunoassay | | |
| Sample type | Human serum | Human serum (collected in
serum and serum separator
tubes) and plasma (collected
in dipotassium EDTA, lithium
heparin, and lithium heparin
plasma separator tubes) | | |
| Result
Interpretation | Visually evaluate multiple
bands | The cutoff is 1.00 S/CO.
95% CI = 88.12%
to 98.09% | | NPA= 98.60%
(212/215);
95% CI = 95.98%
to 99.52% |
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W
10. Stability
The data support the following storage conditions for the ARCHITECT HSV-2 IgG assay:
| Stability Study | Claims |
|---|---|
| Reagent On-Board | Up to 30 days |
| Reagent Unopened Shelf Life | 10 months at 2-8°C |
| Reagent In-Use/Opened | 10 months at 2-8°C |
| Calibrator Unopened Shelf-Life | 12 months at 2-8°C |
| Calibrator In-Use/Opened | 12 months at 2-8°C |
| Controls Unopened Shelf Life | 12 months at 2-8°C |
| Controls In-Use/Opened | 12 months at 2-8°C |
Table 10. ARCHITECT HSV-2 IgG storage conditions
11. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.