(56 days)
Elecsys HSV-2 IgG Immunoassay: The Roche Elecsys HSV-2 IgG immunoassay is a test 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 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 electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and 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 and immunocompromised patients or for use at point of care facilities.
Elecsys PreciControl HSV: The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) Elecsys HSV-2 IgG is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant HSV-2-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-2 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) Elecsys PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HSV-2 IgG immunoassay.
The provided 510(k) summary describes the Elecsys HSV-2 IgG Immunoassay and Elecsys PreciControl HSV. The document focuses on establishing substantial equivalence to a predicate device, rather than defining explicit acceptance criteria and a detailed study proving the device meets those criteria in a typical clinical trial format for a novel device.
However, based on the information provided, we can infer performance characteristics and study details that serve a similar purpose for an IVD (In Vitro Diagnostic) device submission.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria (Inferred from Performance Data) and Reported Device Performance
For an IVD device, acceptance criteria are often defined by demonstrating performance comparable to a legally marketed predicate device, or by meeting certain analytical performance targets for sensitivity, specificity, and agreement. The document frequently compares the candidate device's performance to the predicate device and CDC panel.
| Acceptance Criteria (Inferred) | Reported Device Performance (Elecsys HSV-2 IgG Immunoassay) |
|---|---|
| Sensitivity/Positive Percent Agreement (PPA) | |
| Expectant Mother Cohort: High PPA (e.g., >95%) | 97.83% (95% CI: 88.47-99.94%) |
| Sexually Active Cohort: High PPA (e.g., >90%) | 93.63% (95% CI: 88.60-96.90%) |
| Low Prevalence Cohort: Agreement commensurate with prevalence | 75.00% (95% CI: 19.41-99.37%) |
| Specificity/Negative Percent Agreement (NPA) | |
| Expectant Mother Cohort: High NPA (e.g., >95%) | 98.73% (95% CI: 93.15-99.97%) |
| Sexually Active Cohort: High NPA (e.g., >95%) | 98.72% (95% CI: 96.75-99.65%) |
| Low Prevalence Cohort: High NPA (e.g., >95%) | 98.47% (95% CI: 95.59-99.68%) |
| Agreement with CDC Panel | 100% |
| Analytical Specificity (Cross-Reactivity) | 100% agreement with comparator assay for 311 HSV-2-negative specimens with various cross-reactants. |
| Precision | |
| Intra-assay: Low SD/CV | Low Control: SD 0.005 COI; High Control: CV 1.3% |
| Inter-assay: Low SD/CV | Low Control: SD 0.010 COI; High Control: CV 3.3% |
| Serum Samples: Low SD/CV | < 0.8 COI: SD 0.001 - 0.004 COI; > 0.8 COI: CV 1.2 - 1.6% (Intra-assay), CV 2.8 - 3.6% (Inter-assay) |
| Interference | Unaffected by icterus, hemolysis, lipemia, biotin, rheumatoid factor, and various pharmaceuticals (including Famciclovir, Acyclovir, Valacyclovir). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several cohorts used for performance evaluation:
- Expectant Mother Cohort: n = 125
- Sexually Active Cohort: n = 469
- Low Prevalence Cohort: n = 200
- Analytical Specificity Cohort: 311 HSV-2-negative specimens positive for various cross-reactants.
The data provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided text. It is common for such clinical performance studies for IVDs to use a mix of retrospective and prospective samples collected from diverse populations, but this specific information is missing here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "Agreement with CDC Panel" for which 100% agreement was demonstrated.
For the other performance metrics (Positive Percent Agreement, Negative Percent Agreement), the comparison is made against the Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238), which serves as the comparator or "ground truth" for these studies, referred to as "Relative Sensitivities to Western Blot" and "Relative Specificity to Western Blot."
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set, other than the implicit expertise associated with a "CDC Panel" and the established nature of the predicate device (HerpeSelect 1 and 2 Immunoblot). The predicate device itself relies on qualitative band comparison, which typically involves trained laboratory personnel interpreting the results.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (like 2+1, 3+1) for the interpretation of results in the test set. For IVD devices, especially those with quantitative or semi-quantitative outputs like a Cut-off Index (COI), the result interpretation is typically based on predefined thresholds and calculations rather than subjective expert consensus on each case. The "ground truth" often refers to the result obtained from a gold standard or predicate method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study, which typically evaluates how much human readers improve with AI vs. without AI assistance, is not mentioned or implied. This device is an in vitro diagnostic immunoassay, meaning it directly measures biomarkers in a sample and produces a result (reactive/non-reactive). It's not an imaging or interpretation assistance device where human readers interact with AI output in a diagnostic workflow.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are effectively standalone performance studies. The Elecsys HSV-2 IgG Immunoassay operates as an automated system ("ECLIA" on Elecsys and cobas e immunoassay analyzers). The performance characteristics reported (PPA, NPA, analytical specificity, precision) reflect the device's inherent ability to correctly classify samples based on its internal algorithm and detection method. There is no human-in-the-loop component for result interpretation for a qualitative immunoassay. The device determines if a sample is reactive or non-reactive based on its COI value.
7. Type of Ground Truth Used
The primary ground truth used for performance evaluation appears to be:
- Predicate Device/Comparator Assay: The Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238), described as "Relative Sensitivities to Western Blot" and "Relative Specificity to Western Blot." Western Blot is generally considered a highly specific and often used gold standard for HSV-2 serology.
- CDC Panel: A smaller reference panel from the CDC, against which the device showed 100% agreement.
8. Sample Size for the Training Set
The document does not specify a separate training set size. For IVD devices, especially those based on established immunoassay principles, the "training" (development and optimization) often happens during assay design, reagent formulation, and calibration curve development. The clinical performance data presented here would generally be considered external validation or test set performance, not a training set for an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Since a distinct "training set" in the context of an AI/ML algorithm is not described, the method for establishing its ground truth is not applicable/not provided. The ground truth for the overall assay development and validation would have been established through a combination of well-characterized clinical samples and comparison to established gold standard methods or predicate devices, as seen with the predicate device and CDC panel used for the test set.
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510(k) Summary
AUG 2 4 2012
| 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 Diagnostics9115 Hague RoadP.O. Box 50416Indianapolis, IN 46250-0416Phone: (317) 521-3577Fax: (317) 521-2425 |
| Contact Person: K. Colleen Adams, Regulatory Affairs PrincipalDate Prepared: June 27, 2012 | |
| Device Name | |
| Proprietary name: (1) Elecsys HSV-2 IgG Immunoassay(2) Elecsys PreciControl HSV | |
| Common name: (1) HSV-2 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: MYF, JJX | |
| Predicate Device: Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238) | |
| Continued on next page |
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Device Description
(1) Elecsys HSV-2 IgG is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant HSV-2-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-2 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) Elecsys PreciControl HSV contains lyophilized control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys HSV-2 IgG immunoassay.
Note: The reagent and calibrators are packaged together in the Elecsys HSV-2 IgG assay, while the associated PreciControl is packaged separately.
| IntendedUse/Indicationsfor Use | Elecsys HSV-2 IgG Immunoassay: | |
|---|---|---|
| The Roche Elecsys HSV-2 IgG immunoassay is a test 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 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 electrochemiluminescence immunoassay | ||
| "ECLIA" is intended for use on the indicated Elecsys and 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 and immunocompromised patients or for use at point of care facilities.
Elecsys PreciControl HSV:
The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
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The Elecsys HSV-2 IgG immunoassay test system is substantially Substantial Equivalence equivalent to other devices legally marketed in the United States. (1) Elecsys HSV-2 IgG Immunoassay is equivalent to HerpeSelect 1 and 2 Immunoblot, MRL/Focus Diagnostics (K000238). (2) Elecsys PreciControl HSV is equivalent to the Elecsys PreciControl Anti-CCP (K081338). 1999 - 1999 The following tables compare the Elecsys HSV-2 IgG immunoassay Substantial and PreciControl HSV with their respective predicate devices. Equivalence -Comparison
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| General Assay Features | ||
| Intended Use/Indications for Use | The Roche Elecsys HSV-2 IgGimmunoassay is a test for the in vitroqualitative determination of IgG classantibodies to HSV-2 in human serumand lithium-heparin plasma, K2 -EDTA plasma, and K3-EDTA plasma.The test is intended for sexually activeindividuals and expectant mothers asan aid in presumptive diagnosis ofHSV-2 infection. The predictive valueof positive or negative results dependson the population's prevalence and thepretest likelihood of HSV-2.The electrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on the indicated Elecsys andcobas e immunoassay analyzers.The test is not FDA cleared forscreening blood or plasma donors.The performance of this assay has notbeen established for use in a pediatricpopulation, neonates andimmunocompromised patients or foruse at point of care facilities. | Focus Diagnostics' HerpeSelect 1 and2 Immunoblot IgG test is intended forqualitatively detecting the presence orabsence of human IgG class antibodiesto HSV-1 and HSV-2 in human sera.The test is indicated for testingsexually active adults or expectantmothers for aiding in the presumptivediagnosis of HSV-1 and HSV-2infection. The predictive value of apositive or negative result depends onthe population's prevalence and thepretest likelihood of HSV-1 and HSV-2 infection. The performance of thisassay has not been established for usein a pediatric population, for neonatalscreening, for testing ofimmunocompromised patients, for useby a point of care facility or for usewith automated equipment. |
| AssayProtocol | Sandwich assay | Nitrocellulose immunoblot |
| DetectionProtocol | ElectrochemiluminescentImmunoassay | Alkaline phosphatase (qualitative) |
| Applications | 18 minutes | Manual procedure |
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| InstrumentPlatform | Elecsys 2010, MODULARANALYTICS E170, cobas e 411,cobas e 601, and cobas e 602 | Manual procedure |
| SampleVolume | 20 µL | 20 µL |
| SampleType | Human serum and Lithium-heparin,K2-EDTA, and K3-EDTA plasma | Human serum |
| Reagents | Reagents consist of streptavidin-coated microparticles, biotinylatedHSV-2 antigen (recombinant, from E.coli), ruthenylated HSV-2 antigen andnegative and positive calibrators. | Reagents consist of HSV-1 and HSV-2 differentiation antigen strips,alkaline phosphatase-conjugated goatanti-human IgG, bromo-chloro-indodyl phosphate and nitrobluetetrazolium substrate and negative andpositive controls. |
| Calibrator | Included with the reagent kit | Not included with this qualitative test |
| CalibrationInterval | Calibration must be performed onceper reagent lot using fresh reagent (i.e.not more than 24 hours since thereagent kit was registered on theanalyzer). Renewed calibration isrecommended as follows:• After 1 month (28 days) whenusing the same reagent lot.• After 7 days (when using the samereagent kit on the analyzer).• As required: e.g. quality controlfindings outside the specifiedlimits | Calibrators are not included for thisqualitative assay. Negative andpositive controls are run with everytest. |
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| General Assay Features | ||
| Controls | Elecsys PreciControl HSV | Negative and positive controls areincluded with the Focus kit. |
| Traceability /Standardization | The Elecsys HSV-2 IgGimmunoassay has been standardizeda Roche standard. The units havebeen selected arbitrarily. | There is no standardization for thisqualitative assay. |
| ReagentStability | Reagents, ready to use:2-8°C – Up to the stated expirationdateAfter opening at 2-8°C – 8 weeksOn the analyzers – 21 daysCalibrators (lyophilized):Unopened at 2-8°C – Up to statedexpiration dateAfter reconstitution at 2-8°C – 14daysOn the Elecsys 2010 and cobas e 41120-25°C – Up to 5 hoursOn the MODULAR ANALYTICSE170, cobas e 601, and cobas e 602– Use only once | Kits and reagents are stable throughthe end of the month indicated on theirexpiration dates when stored at 2-8°C. |
| Cutoffs | The analyzer automatically calculatesthe cutoff based on the measurementof Cal 1 and Cal 2. The result of asample is given either as reactive ornon-reactive as well as in the form ofa cutoff index. | Positive or negative results aregenerated by this qualitative assay bycomparing bands on the nitrocelluloseto a cut-off/control strip. |
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| General assay features | ||
| Cutoffs(continued) | For the Elecsys HSV-2 IgGimmunoassay, the interpretation of theresults is: | |
| Non-reactive < $1.0$ COIReactive ≥ $1.0$ COI | ||
| ResultInterpretation | Samples with a cutoff index < $1.0$ arenon-reactive in the Elecsys HSV-2IgG assay. These samples areconsidered negative for HSV-2 IgG-specific antibodies and do not needfurther testing. Samples with a cutoffindex of ≥ $1.0$ are considered reactivein the Elecsys HSV-2 IgG assay. | Compare each band on a striprelative to the reading control band.The reading control band is the IgG-2 band on the Cutoff/PositiveControl strip. If the band is as dark,or darker than the reading controlband, then the band is reactive (+).Likewise, if the band is lighter thanthe reading control band, then theband is unreactive (neg.). Theoverall band reactivity is then usedto interpret results. |
| Limits ofMeasurement | LoB = $0.11$ COILoD = $0.1244$ COI | Not applicable to this qualitativetest |
| Hook Effect | No hook effect up to $10$ COI | Not tested |
Comparison of Assays—Similarities and Differences
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Comparison of Assays—Similarities and Differences i
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Reagent andCalibrator(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| Labeled Performance Characteristics | ||
| Precision | Intra-assay:Low Control: SD 0.005 COIHigh Control: CV 1.3%Serum Samples < 0.8 COI:SD 0.001 - 0.004 COISerum Samples > 0.8 COI:CV 1.2 - 1.6%Inter-assay:Low Control: SD 0.010 COIHigh Control: CV 3.3%Serum Samples < 0.8 COI:SD 0.002 - 0.007 COISerum Samples > 0.8 COI:CV 2.8 - 3.6% | Inter Laboratory Reproducibility: Aninternal investigator and 2 externallaboratories assessed the device'sreproducibility. Seven samples wererun in triplicate on 3 different days.Using the Focus Elisa Index (negativeif less than 0.90, equivocal if between0.90 and 1.10, and positive if greaterthan 1.10) the manufacturer was ableto demonstrate 100% agreement withintra-assay, inter-assay, inter-lot andinter-lab precision testing. |
Comparison of Assays-Similarities and Differences, continued
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| Labeled Performance Characteristics | ||
| AnalyticalSpecificity | 311 HSV-2-negative specimens,which were positive for the followingcross reactants, were tested with theElecsys HSV-2 IgG and thecomparator assay: Antinuclearantibodies, Varicella zoster virus,Human indefficiency virus,Cytomegalovirus, Neisseriagonorrhea, Toxoplasma gondi,Chlamydia trachomatis, Candidaalbicans, Epstein Barr virus, Rubella,E. Coli, HSV-1, and Treponemapallidum. 100% agreement wasdemonstrated between the two assays. | The sponsor tested 32 HSV negativesamples which were positive forCytomegalovirus, Epstein Barr virus,Virus Capsid antigen, Humanherpesvirus6 or Varicella zoster virus.Eight of the samples were found to bepositive with the Focus Immunoblot,while the 24 remaining samples werenegative. |
Comparison of Assays-Similarities and Differences, continued
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| Comparison of Assays-Similarities and Differences, continued | ||
|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| Labeled Performance Characteristics | ||
| Limitations | A negative test result does notcompletely rule out the possibility ofan infection with HSV-2 asindividuals may not exhibit anydetectable IgG antibodies at the earlystage of acute infection.False negative results may occur whenthe HSV virus is glycoprotein G (gG)deficient (0.2 % HSV isolates were gGdeficient).The detection of HSV-2-specific IgGantibodies in a single sample indicatesa previous exposure to HSV-2 butdoes not give any information of thetime point of an exposure.Elecsys HSV-2 IgG results should beused in conjunction with the patient'smedical history and clinicalsymptoms.The results in HIV patients, in patientsundergoing immunosuppressivetherapy, or in patients with otherdisorders leading to immunesuppression, should be interpretedwith caution.Specimens from neonates, cord blood,pretransplant patients or body fluidsother than serum and plasma, such asurine, saliva, or amniotic fluid havenot been tested. | The performance of this assay hasnot been established for the generalpopulation. The performance of this assay hasnot been established for ruling outdiseases with similar symptoms,e.g., Candida albicans, Bacteriodesspecies, G. vaginalis, Mobiluncusspecies. Instead, also use culture orother appropriate methods. The performance of this assay hasnot been established for matricesother than serum, or visual resultdetermination(s), or monitoringHSV therapy. All results from thisand other serologies must becorrelated with clinical history,epidemiological data, and otherdata available to the attendingphysician in evaluating the patient. The prevalence of infection willaffect the assay's predictive value. As with other serological tests,negative results do not rule out thediagnosis of herpes simplexdisease. The time required toseroconvert following the primaryinfection varies with theindividual; the specimen may havebeen drawn prior to the appearanceof detectable antibodies. False negative results may occurwhen the infecting virus is gGdeficient, or because it is unknownif the assay's antigen wasglycosylated the same asmammalian cells. |
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys HSV-2 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 (< 1500IU/mL). | • As with other serological tests,false positive results may occur.Repeat testing or testing with adifferent device may be indicatedin some settings, e.g., patients witha low likelihood of HSV infection.• A single positive result onlyindicates previous immunologicexposure; level of antibodyresponse or class of antibodyresponse may not be used todetermine active infection ordisease state.• The magnitude of the index valueabove the Cut-off does not indicatethe total amount of antibodypresent.• Serology cannot distinguish genitalfrom oral infections. Whenappropriate, culture isrecommended to identify theinfection site. However, falsenegative HSV cultures arecommon, especially in patientswith recurrent infection or withhealing lesions. |
| Criterion: Mean recovery of positivesamples within ± 20 % of serum value.Correct assignment of negativesamples and recovery of positivesamples ± 20 %. | ||
| Samples should not be taken frompatients receiving therapy with highbiotin doses (i.e. > 5 mg/day) until atleast 8 hours following the last biotinadministration. | ||
| No interference was observed fromrheumatoid factors up to aconcentration of 1500 IU/mL. | ||
| In vitro tests were performed on 18commonly used pharmaceuticals andin addition on Famciclovir, Acyclovirand Valacyclovir. No interferencewith the assay was found. | ||
| Assay performance for sodium citrateplasma has not been evaluated. |
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|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| Labeled Performance Characteristics | ||
| Limitations,continued | In rare cases, interference due toextremely high titers of antibodies tostreptavidin or ruthenium can occur.These effects are minimized bysuitable test design.Cross-reactivity for HPV and varioustypes of bacterial vaginosis-causingagents (e.g., Mobiluncus spec,Gardnerella vaginalis, andBacteroides spec) were not evaluatedin the performance analysis of thisassay. The influence of the serologicalresponse against any of these agentson the results of the Elecsys HSV-2 IgG immunoassay is unknown.Sample stability studies wereperformed using serum only.Results should always be assessed inconjunction with the patient's medicalhistory, clinical examination and otherfindings. |
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| Immunoassay Comparison, continued | ||
|---|---|---|
| Feature | Elecsys HSV-2 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| Labeled Performance Characteristics | ||
| PercentAgreementandSensitivity/Specificity | Expectant Mother Cohort (n=125) | Relative Sensitivities to WesternBlot |
| Positive Percent Agreement (95% CI): | Pregnant Cohort: 100% | |
| 97.83% (88.47-99.94%) | Sexually Active Adults: 99.3% | |
| Negative Percent Agreement (95% CI): | Low Prevalence Population: 82.4% | |
| 98.73% (93.15-99.97%) | ||
| Sexually Active Cohort (n=469) | Relative Specificity to Western Blot | |
| Positive Percent Agreement (95% CI): | Pregnant Cohort: 93.1% | |
| 93.63% (88.60-96.90%) | Sexually Active Adults: 95.1% | |
| Negative Percent Agreement (95% CI):98.72% (96.75-99.65%) | Low Prevalence Population: 100% | |
| Low Prevalence Cohort (n=200) | ||
| Positive Percent Agreement (95% CI):75.00% (19.41-99.37%) | ||
| Negative Percent Agreement (95% CI):98.47% (95.59-99.68%) | ||
| Agreementwith CDCPanel | 100% | 100% |
Comparison of Assays—Similarities and Differences, continued
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| Comparison of Controls – Similarities and Differences | ||
|---|---|---|
| Characteristic | Elecsys PreciControl HSV(Candidate Device) | Predicate Device:Elecsys PreciControl Anti-CCP(K081338) |
| Intended Use | The Elecsys PreciControl HSV is usedfor quality control of the ElecsysHSV-2 IgG immunoassay on theElecsys and cobas e immunoassayanalyzers. | Elecsys PreciControl Anti-CCP isused for quality control of theElecsys Anti-CCP immunoassay onthe Elecsys and cobas eimmunoassay analyzers. |
| Levels | Two | Two |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum negative for HSV-2 IgGantibodies | Human serum |
| Analyte | PreciControl 1: ~ 0.30 COI | PreciControl 1: ~20 U/mL |
| Concentration | PreciControl 2: ~ 8.00 COI | PreciControl 2: ~100 U/mL |
| Stability | Unopened:● Store at 2-8°C up to the statedexpiration dateReconstituted:● 2 - 8°C: 21 days● On the Elecsys 2010 and cobas e411 analyzers at 20-25°C: Up to5 hours● On the MODULARANALYTICS E170, cobas e 601,and cobas e 602 analyzers: Up to2 hours | Unopened:● Store at 2-8°C up to thestated expiration dateReconstituted:● -20°C: 1 month (freeze onlyonce)● On the analyzers at 20-25°C: Up to 5 hours● After thawing: Use onlyonce |
| Handling | Dissolve carefully the contents of onebottle by adding exactly 3.0 mL ofdistilled or deionized water and allowto stand closed for 15 minutes toreconstitute. Mix carefully, avoidingthe formation of foam. Use a pipette totransfer the reconstituted control of 1bottle into empty labeled Elecsyssnap-cap bottles supplied. | Dissolve carefully the contents ofone bottle by adding exactly 2.0 mLof distilled water and allow to standclosed for 15 minutes toreconstitute. Mix carefully,avoiding the formation of foam.Transfer aliquots of the freshlyreconstituted controls intoappropriate tubes for storage. Storethe aliquots immediately at -20°C. |
Comparison of Controls - Similarities and Differences
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Ms. K. Colleen Adams Regulatory Affairs Principal 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250-0416
AUG 2 4 2012
Re: K121895
Trade/Device Name: Elecsys HSV-2 IgG Immunoassay and PreciControl HSV Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF, JJX Dated: June 27, 2012 Received: June 29, 2012
Dear Ms. Adams:
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 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
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Page 2 - Ms. Colleen Adams
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,
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
Elecsvs HSV-2 IgG Immunoassay and PreciControl HSV Device Name:
Indications for Use:
Elecsys HSV-2 IgG Immunoassay
The Roche Elecsvs HSV-2 IgG immunoassay is a test 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 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 electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and 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 and immunocompromised patients or for use at point of care facilities.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
fayann
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121895
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Indications for Use
Elecsys PreciControl HSV
The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
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)
Tamara Tedder
Division Sign-Off
Division Sign-Off
- Office of In Vitro Diagnostic Device Eyaluation and Safety
510(k) K121895
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.