Who is the manufacturer of ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

Roche Diagnostics filed the 510(k) submission for ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV (K120625).

What is the FDA product code for ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

MXJ. It is classified under 21 CFR 866.3305 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

Q: What are the predicate devices for ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV?

Focus HerpeSelect® 1 and 2 Immunoblot IgG (K000238).

K120625 · Roche Diagnostics · MXJ · Jul 25, 2012 · Microbiology

Device Facts

Record ID	K120625
Device Name	ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV
Applicant	Roche Diagnostics
Product Code	MXJ · Microbiology
Decision Date	Jul 25, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3305
Device Class	Class 2

Intended Use

The Roche Elecsys HSV-1 IgG immunoassay is a test 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 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 Elecsys and cobas e immunoassay analyzers. The 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. PreciControl HSV is used for quality control of the Elecsys HSV-1 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Two-step sandwich electrochemiluminescence immunoassay (ECLIA) for qualitative detection of IgG antibodies to HSV-1; uses biotinylated recombinant HSV-1-specific antigen and ruthenium-labeled complex; streptavidin-coated microparticles capture complexes on electrode surface; chemiluminescent emission measured by photomultiplier. Used in clinical laboratories on Roche cobas e 411/601 analyzers; operated by laboratory technicians. Input: human serum or plasma; output: Cut-off index (COI) value. Results interpreted as reactive (≥1.0 COI) or non-reactive (<1.0 COI). Aids clinicians in presumptive diagnosis of HSV-1 infection; predictive value depends on population prevalence and pretest likelihood.

Clinical Evidence

Multi-center prospective study (n=800) including sexually active adults (n=600) and low-prevalence population (n=200). Performance compared to FDA-cleared immunoblot and Western blot. In sexually active adults: sensitivity 94.20% (95% CI: 91.27-96.37), specificity 90.34% (95% CI: 85.85-93.77). In expectant mothers: sensitivity 91.0% (95% CI: 82.4-96.3), specificity 95.7% (95% CI: 85.5-99.5). CDC panel (n=100) showed 100% positive and negative agreement.

Technological Characteristics

Two-step sandwich ECLIA; uses streptavidin-coated microparticles and biotinylated recombinant HSV-1 antigen labeled with ruthenium complex. Automated platform (Elecsys/cobas e series). Sample volume 20 µL. Calibration is lot-specific, two-point. Stability: 8 weeks opened at 2-8°C, 21 days on-board. Software-based automated calculation of COI. No specific ASTM standards cited.

Indications for Use

Indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 infection. Not for use in pediatric populations, neonates, immunocompromised patients, or point-of-care facilities. Not for blood/plasma donor screening.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Focus HerpeSelect® 1 and 2 Immunoblot IgG (K000238)

Related Devices

K220923 — Elecsys HSV-1 IgG (08948844160) · Roche Diagnostics · Oct 12, 2022
K162276 — SeraQuest Herpes Type 1 Specific IgG · Quest International, Inc. · Oct 1, 2016
K121895 — ELECSYS HSV-2 IGG IMMUNOASSAY · Roche Diagnostics · Aug 24, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 120625 # 510(k) Summary JUL 2 5 2012 1 | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name, Address, Contact | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Phone: (317) 521-2458 Fax: (317) 521-2324 Email: colleen.adams@roche.com | | | Contact Person: K. Colleen Adams, Regulatory Affairs Principal | | | Date Prepared: February 29, 2012 | | Device Name | | | | Proprietary name: (1) Elecsys HSV-1 IgG Immunoassay (2) PreciControl HSV | | | Common name: (1) HSV-1 IgG (2) PreciControl HSV | | | Classification name: (1) Class 2, 21 CFR 866.3305, Herpes simplex virus serological assays (2) Class 1, 21 CFR 862.1660, Quality control material (assayed and unassayed) | | | Product Code: (1) MXJ (2) JJX | | | Predicate Device: Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238) | Continued on next page {1}------------------------------------------------ (1) The Elecsys HSV-1 IgG immunoassay is a two-step sandwich Device immunoassay with streptavidin microparticles, biotinylated recombinant Description HSV-1-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. This assay is a qualitative test based on a cut-off formula dependent on the negative and positive calibrators. Cut-off index (COI) is based on the ratio of assay signal to cut-off signal (also abbreviated s/co). COI values greater than or equal to 1.0 are considered positive for the presence of anti-HSV-1 IgG antibody. Results are determined using a two-point calibration. The test system contains the human serum-based calibrators intended for use with the system. (2) PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HSV-1 IgG immunoassay. Note: The reagents and calibrator are packaged together in the Elecsys HSV-1 IgG immunoassay, while the associated PreciControl is packaged separately. Elecsys HSV-1 IgG Immunoassay: Intended The Roche Elecsys HSV-1 IgG immunoassay is a test for the in vitro Use/Indications for Use 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 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 Elecsys and cobas e immunoassay analyzers. The 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. Continued on next page 2 {2}------------------------------------------------ · ____________________________________________________________________________________________________________________________________________________________________________ : | Intended Use/Indications for Use, continued | PreciControl HSV: PreciControl HSV is used for quality control of the Elecsys HSV-1 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers. | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence | The Elecsys HSV-1 IgG test system is substantially equivalent to other devices legally marketed in the United States. | | | (1) Elecsys HSV-1 IgG immunoassay is equivalent to HerpeSelect 1 and 2 Immunoblot, MRL/Focus Diagnostics (K000238). | | | (2) PreciControl HSV is equivalent to the Elecsys PreciControl Anti-CCP (K081338). | | Substantial Equivalence - Comparison | The following tables compare the Elecsys HSV-1 IgG immunoassay and PreciControl HSV with their respective predicate devices. | | | Continued on next page | ' : ・ 3 {3}------------------------------------------------ | Immunoassay Comparison | | | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys HSV-1 IgG Immunoassay (Candidate Device) | Focus HerpeSelect 1&2 (Predicate Device: K000238) | | | General Assay Features | | | Intended Use/ Indications for Use | The Roche Elecsys HSV-1 IgG immunoassay is a test 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 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 Elecsys and cobas e immunoassay analyzers. The 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. | Focus Diagnostics' HerpeSelect 1 and 2 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 the 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 of care facility or for use with automated equipment. | | Assay Protocol | Sandwich assay | Nitrocellulose immunoblot | | Detection Protocol | Electrochemiluminescent Immunoassay | Alkaline phosphatase (qualitative) | | Applications | 18 minutes | Manual procedure | | Immunoassay Comparison | | | | Feature | Elecsys HSV-1 IgG Immunoassay (Candidate Device) | Focus HerpeSelect 1&2 (Predicate Device: K000238) | | General Assay Features | | | | Instrument Platform | Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 | Manual procedure | | Sample Volume | 20 µL | 20 µL | | Sample Type | Human serum and Lithium-heparin, K2-EDTA, and K3-EDTA plasma | Human serum | | Reagents | Reagents consist of streptavidin- coated microparticles, biotinylated HSV-1 antigen (recombinant, from E. coli ), ruthenylated HSV-1 antigen, and negative and positive calibrators. | Reagents consist of HSV-1 and HSV- 2 differentiation antigen strips, alkaline phosphatase-conjugated goat anti-human IgG, bromo-chloro- indodyl phosphate and nitroblue tetrazolium substrate and negative and positive controls. | | Calibrator | Included with the reagent kit | Not included with this qualitative test | | Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Renewed calibration is recommended as follows: • After 1 month (28 days) when using the same reagent lot. • After 7 days (when using reagents kept on board the analyzer). • As required: e.g. quality control findings outside the specified | Calibrators are not included for this qualitative assay. Negative and positive controls are run with every test. | ### Comparison of Assays—Similarities and Differences {4}------------------------------------------------ ## Comparison of Assays—Similarities and Differences, continued Continued on next page . . {5}------------------------------------------------ | Immunoassay Comparison | | | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys HSV-1 IgG Immunoassay (Candidate Device) | Focus HerpeSelect 1&2 (Predicate Device: K000238) | | | General Assay Features | | | Controls | PreciControl HSV | Negative and positive controls are included with the Focus kit. | | Traceability / Standardization | The Elecsys HSV-1 IgG immunoassay has been standardized against a Roche standard. The units have been selected arbitrarily. | There is no standardization for this qualitative assay. | | Reagent Stability | Reagents, ready to use: Unopened at 2-8°C - up to the stated expiration date After opening at 2-8°C - 8 weeks On the analyzers - 21 days Calibrators (lyophilized): Unopened at 2-8°C - up to stated expiration date After reconstitution at 2-8°C - 14 days On the Elecsys 2010 and cobas e 411 20-25°C - up to 5 hours On the MODULAR ANALYTICS E170, cobas e 601, and cobas e 602 - use only once | Kits and reagents are stable through the end of the month indicated on their expiration dates when stored at 2-8°C. | | Cutoffs | The analyzer automatically calculates the cutoff based on the measurement of Cal 1 and Cal 2. The result of a sample is given either as reactive or non-reactive as well as in the form of a cutoff index. | Positive or negative results are generated by this qualitative assay by comparing bands on the nitrocellulose to a cut-off/control strip. | #### Comparison of Assays—Similarities and Differences, continued {6}------------------------------------------------ . . ## 510(k) Summary, Continued | Comparison of Assays—Similarities and Differences, continued | | | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Immunoassay Comparison | | | | Feature | Elecsys HSV-1 IgG Immunoassay (Candidate Device) | Focus HerpeSelect 1&2 (Predicate Device: K000238) | | | General assay features | | | Cutoffs (continued) | For the Elecsys HSV-1 IgG immunoassay, the interpretation of the results is: | | | | Non-reactive < $1.0$ COI | | | | Reactive ≥ $1.0$ COI | | | Result Interpretation | Samples with a cutoff index < $1.0$ are non-reactive in the Elecsys HSV-1 IgG immunoassay. These samples are considered negative for HSV-1 IgG- specific antibodies and do not need further testing. Samples with a cutoff index of ≥ $1.0$ are considered reactive in the Elecsys HSV-1 IgG immunoassay. | Compare each band on a strip relative to the reading control band. The reading control band is the IgG- 2 band on the Cutoff/Positive Control strip. If the band is as dark, or darker than the reading control band, then the band is reactive (+). Likewise, if the band is lighter than the reading control band, then the band is unreactive (neg.). The overall band reactivity is then used to interpret results. | | Limits of Measurement | LoB = $0.030$ COI LoD = $0.044$ COI | Not applicable to this qualitative test | | Hook Effect | No hook effect up to $10$ COI | Not tested | #### of Assays-Similarities and Differences, continued ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ mnorison. {7}------------------------------------------------ # 510(k) Summary, Continued | Comparison of Assays—Similarities and Differences, continued Immunoassay Comparison | | | |----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys HSV-1 IgG Immunoassay (Candidate Device) | Focus HerpeSelect 1&2 (Predicate Device: K000238) | | | Labeled Performance Characteristics | | | Precision | Intra-assay: Low Control: SD 0.003 COI High Control: CV 1.0% Serum Samples < 0.8 COI: SD 0.001 – 0.006 COI Serum Samples > 0.8 COI: CV 1.0 – 1.3% Inter-assay: Low Control: SD 0.006 COI High Control: CV 2.5% Serum Samples < 0.8 COI: SD 0.001 – 0.012 COI Serum Samples > 0.8 COI: CV 2.6 – 2.9% | Inter Laboratory Reproducibility: An internal investigator and 2 external laboratories assessed the device's reproducibility. Seven samples were run in triplicate on 3 different days. Using the Focus Elisa Index (negative if less than 0.90, equivocal if between 0.90 and 1.10, and positive if greater than 1.10) the manufacturer was able to demonstrate 100% agreement with intra-assay, inter-assay, inter-lot and inter-lab precision testing. | | Analytical Specificity | 129 HSV-negative specimens, which were positive for the following cross reactants, were tested with the Elecsys HSV-1 IgG immunoassay and the comparator assay: Antinuclear antibodies, Varicella zoster virus, Human deficiency virus, Cytomegalovirus, Neisseria gonorrhea, Toxoplasma gondi, Chlamydia trachomatis, Candida albicans, Epstein Barr virus, Rubella, E. Coli, Treponema pallidum, and HSV-2. 100% agreement was demonstrated between the two assays. | The sponsor tested 32 HSV negative samples which were positive for Cytomegalovirus, Epstein Barr virus, Virus Capsid antigen, Human herpesvirus6 or Varicella zoster virus. Eight of the samples were found to be positive with the Focus Immunoblot, while the 24 remaining samples were negative. | | Comparison of Assays-Similarities and Differences, continued Immunoassay Comparison | | | | Elecsys HSV-1 IgG Immunoassay | | Focus HerpeSelect 1&2 | | Feature | (Candidate Device) | (Predicate Device: K000238) | | | Labeled Performance Characteristics | | | Limitations | A negative test result does not completely rule out the possibility of an infection with HSV-1 as individuals may not exhibit any detectable IgG antibodies at the early stage of acute infection. | The performance of this assay has not been established for the general population. | | | False negative results may occur when the HSV virus is glycoprotein G (gG) deficient (0.2 % HSV isolates were gG deficient). | The performance of this assay has not been established for ruling out diseases with similar symptoms, e.g., Candida albicans, Bacteriodes species, G. vaginalis, Mobiluncus species. Instead, also use culture or other appropriate methods. | | | The detection of HSV-1-specific IgG antibodies in a single sample indicates a previous exposure to HSV-1 but does not give any information of the time point of an exposure. | The performance of this assay has not been established for matrices other than serum, or visual result determination(s), or monitoring HSV therapy. All results from this and other serologies must be correlated with clinical history, epidemiological data, and other data available to the attending physician in evaluating the patient. | | | Results from the Elecsys HSV-1 IgG immunoassay should be used in conjunction with the patient's medical history and clinical symptoms. | The prevalence of infection will affect the assay's predictive value. | | | The results in HIV patients, in patients undergoing immunosuppressive therapy, or in patients with other disorders leading to immune suppression, should be interpreted with caution. | As with other serological tests, negative results do not rule out the diagnosis of herpes simplex disease. | | | Specimens from neonates, cord blood, pretransplant patients or body fluids other than serum and plasma, such as urine, saliva or amniotic fluid have not been tested. | The time required to seroconvert following the primary infection varies with the individual; the specimen may have been drawn prior to the appearance of detectable antibodies. | | Immunoassay Comparison | | | | Feature | Elecsys HSV-1 IgG Immunoassay (Candidate Device) | Focus HerpeSelect 1&2 (Predicate Device: K000238) | | | Labeled Performance Characteristics | | | Limitations, continued | The assay is unaffected by icterus (bilirubin < 1130 µmol/L or < 66 mg/dL), hemolysis (Hb < 0.621 mmol/L or < 1000 mg/dL), lipemia (Intralipid < 2000 mg/dL), biotin (< 287 nmol/L or < 70 ng/mL), and rheumatoid factor (< 1500 IU/mL). | False negative results may occur when the infecting virus is gG deficient, or because it is unknown if the assay's antigen was glycosylated the same as mammalian cells. | | | Criterion: Mean recovery of positive samples within ± 20 % of serum value. Correct assignment of negative samples and recovery of positive samples ± 20 %. | As with other serological tests, false positive results may occur. Repeat testing or testing with a different device may be indicated in some settings, e.g., patients with a low likelihood of HSV infection. | | | Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration. | A single positive result only indicates previous immunologic exposure; level of antibody response or class of antibody response may not be used to determine active infection or disease state. | | | No interference was observed from rheumatoid factors up to a concentration of 1500 IU/mL. | The magnitude of the index value above the Cut-off does not indicate the total amount of antibody present. | | | In vitro tests were performed on 18 commonly used pharmaceuticals and in addition on Famciclovir, Aciclovir and Valaciclovir. No interference with the assay was found. | Serology cannot distinguish genital from oral infections. When appropriate, culture is recommended to identify the infection site. However, false negative HSV cultures are common, especially in patients with recurrent infection or with healing lesions. | | | Assay performance for sodium citrate plasma has not been evaluated. | | | Comparison of Assays-Similarities and Differences, continued Immunoassay Comparison | | | | Feature | Elecsys HSV-1 IgG Immunoassay (Candidate Device) | Focus HerpeSelect 1&2 (Predicate Device: K000238) | | | Labeled Performance Characteristics | | | Limitations, continued | In rare cases, interference due to extremely high titers of antibodies to streptavidin or ruthenium can occur. These effects are minimized by suitable test design. | | | | Cross reactivity for HPV and various types of bacterial vaginosis-causing agents (e.g., Mobiluncus spec, Gardnerella vaginalis, and Bacteroides spec) were not evaluated in the performance analysis of this assay. The influence of the serological response against any of these agents on the results of the Elecsys HSV-1 IgG immunoassay is unknown. |…

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!