(146 days)
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.
(1) The Elecsys HSV-1 IgG immunoassay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant 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.
Here's an analysis of the acceptance criteria and study details for the Elecsys HSV-1 IgG Immunoassay, extracted from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys HSV-1 IgG Immunoassay are demonstrated through its agreement with a Western Blot (WB) assay within different cohorts. The performance is reported as Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).
| Performance Metric | Cohort | Acceptance Criteria (Implicit, based on reported performance) | Reported Device Performance (95% CI) |
|---|---|---|---|
| Positive Percent Agreement (PPA) | Expectant Mother Cohort | Not explicitly stated as a numerical criterion, but demonstrated by achieving the reported value. | 91.0% (82.4-96.3%) |
| Sexually Active Cohort | Not explicitly stated as a numerical criterion, but demonstrated by achieving the reported value. | 94.2% (91.3-96.4%) | |
| Low Prevalence Cohort | Not explicitly stated as a numerical criterion, but demonstrated by achieving the reported value. | 94.9% (87.4-98.6%) | |
| Negative Percent Agreement (NPA) | Expectant Mother Cohort | Not explicitly stated as a numerical criterion, but demonstrated by achieving the reported value. | 95.7% (85.5-99.5%) |
| Sexually Active Cohort | Not explicitly stated as a numerical criterion, but demonstrated by achieving the reported value. | 90.3% (85.9-93.8%) | |
| Low Prevalence Cohort | Not explicitly stated as a numerical criterion, but demonstrated by achieving the reported value. | 96.7% (91.8-99.1%) | |
| Agreement with CDC Panel | (General) | 100% agreement. | 100% |
Note: The document implicitly establishes the reported performance as meeting acceptance criteria by presenting it in the context of substantial equivalence.
2. Sample Sizes Used for the Test Set and Data Provenance
- Expectant Mother Cohort: n=125
- Sexually Active Cohort: n=600
- Low Prevalence Cohort: n=200
- CDC Panel: Not explicitly stated, but 100% agreement indicates a comparison against a reference standard panel.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the device's performance comparison was established using a Western Blot (WB) assay as the comparator (predicate device: Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238)). This is a laboratory test, not an interpretation by human experts.
For the "Agreement with CDC Panel," the CDC panel itself represents a reference standard, implying established truth without direct mention of human experts in this section.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving multiple human readers for the test set. The direct comparison is between the candidate device (Elecsys HSV-1 IgG Immunoassay) and a predicate Western Blot assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the performance of the device against a predicate laboratory assay (Western Blot), not against human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance study performed appears to be a standalone assessment of the Elecsys HSV-1 IgG Immunoassay. The assay produces a quantitative result (Cut-off Index, COI) that is interpreted as reactive (≥ 1.0 COI) or non-reactive (< 1.0 COI). This is an automated algorithmic output, and its performance is compared directly to the Western Blot without human interpretation loops being described as part of the core performance evaluation study.
7. The Type of Ground Truth Used
The primary ground truth used for establishing the performance metrics (Positive Percent Agreement and Negative Percent Agreement) was the Focus HerpeSelect 1 and 2 Immunoblot IgG (K000238) Western Blot assay. This is a laboratory-based serological test, which serves as a reference standard for HSV-1 IgG antibody detection. Additionally, agreement with a CDC Panel was used as a ground truth comparison.
8. The Sample Size for the Training Set
The document does not provide information regarding the sample size of a training set for the Elecsys HSV-1 IgG Immunoassay. As this is a laboratory immunoassay and not an AI/machine learning algorithm in the typical sense of needing a distinct training set for model development, such information is generally not applicable or explicitly provided in this type of submission. The device's cut-off is based on a formula dependent on calibrators.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI/machine learning model is described, the method for establishing its ground truth is not applicable or provided in the document. The assay's operational parameters, including cut-offs, are established through internal assay development and calibration procedures.
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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 Diagnostics9115 Hague RoadIndianapolis, IN 46250Phone: (317) 521-2458Fax: (317) 521-2324Email: 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) |
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(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
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| IntendedUse/Indicationsfor Use,continued | PreciControl HSV:PreciControl HSV is used for quality control of the Elecsys HSV-1 IgGimmunoassay on the Elecsys and cobas e immunoassay analyzers. |
|---|---|
| SubstantialEquivalence | The Elecsys HSV-1 IgG test system is substantially equivalent to otherdevices legally marketed in the United States. |
| (1) Elecsys HSV-1 IgG immunoassay is equivalent to HerpeSelect 1and 2 Immunoblot, MRL/Focus Diagnostics (K000238). | |
| (2) PreciControl HSV is equivalent to the Elecsys PreciControlAnti-CCP (K081338). | |
| SubstantialEquivalence -Comparison | The following tables compare the Elecsys HSV-1 IgG immunoassayand PreciControl HSV with their respective predicate devices. |
| Continued on next page |
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| 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 IgGimmunoassay is a test for the in vitroqualitative determination of IgG classantibodies to HSV-1 in human serumand lithium-heparin plasma, K2-EDTA plasma, and K3-EDTAplasma. The test is intended forsexually active individuals andexpectant mothers as an aid in thepresumptive diagnosis of HSV-1infection. The predictive value ofpositive and negative results dependson the population's prevalence and thepretest likelihood of HSV-1.The electrochemiluminescenceimmunoassay “ECLIA” is intendedfor use on Elecsys and cobas eimmunoassay 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,immunocompromised 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-1 IgG Immunoassay(Candidate Device) | Focus HerpeSelect 1&2(Predicate Device: K000238) |
| General Assay Features | ||
| 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-1 antigen (recombinant, from E. coli ), ruthenylated HSV-1 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 reagentskept on board the analyzer).• As required: e.g. quality controlfindings outside the specified | Calibrators are not included for thisqualitative assay. Negative andpositive controls are run with everytest. |
Comparison of Assays—Similarities and Differences
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Comparison of Assays—Similarities and Differences, continued
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| 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 areincluded with the Focus kit. |
| Traceability /Standardization | The Elecsys HSV-1 IgGimmunoassay has been standardizedagainst a Roche standard. The unitshave been selected arbitrarily. | There is no standardization for thisqualitative assay. |
| ReagentStability | Reagents, ready to use:Unopened at 2-8°C - up to the statedexpiration dateAfter 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. |
Comparison of Assays—Similarities and Differences, continued
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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 IgGimmunoassay, the interpretation of theresults is: | |
| Non-reactive < $1.0$ COI | ||
| Reactive ≥ $1.0$ COI | ||
| ResultInterpretation | Samples with a cutoff index < $1.0$ arenon-reactive in the Elecsys HSV-1IgG immunoassay. These samples areconsidered negative for HSV-1 IgG-specific antibodies and do not needfurther testing. Samples with a cutoffindex of ≥ $1.0$ are considered reactivein the Elecsys HSV-1 IgGimmunoassay. | 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 = $0.030$ COILoD = $0.044$ COI | Not applicable to this qualitativetest |
| Hook Effect | No hook effect up to $10$ COI | Not tested |
of Assays-Similarities and Differences, continued ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ mnorison.
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510(k) Summary, Continued
| Comparison of Assays—Similarities and Differences, continuedImmunoassay 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 COIHigh Control: CV 1.0%Serum Samples < 0.8 COI:SD 0.001 – 0.006 COISerum Samples > 0.8 COI:CV 1.0 – 1.3%Inter-assay:Low Control: SD 0.006 COIHigh Control: CV 2.5%Serum Samples < 0.8 COI:SD 0.001 – 0.012 COISerum 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. |
| AnalyticalSpecificity | 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, continuedImmunoassay 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 notcompletely rule out the possibility ofan infection with HSV-1 asindividuals may not exhibit anydetectable IgG antibodies at the earlystage of acute infection. | The performance of this assay has notbeen established for the generalpopulation. |
| False negative results may occur whenthe HSV virus is glycoprotein G (gG)deficient (0.2 % HSV isolates were gGdeficient). | The performance of this assay has notbeen established for ruling outdiseases with similar symptoms, e.g.,Candida albicans, Bacteriodesspecies, G. vaginalis, Mobiluncusspecies. Instead, also use culture orother appropriate methods. | |
| The detection of HSV-1-specific IgGantibodies in a single sample indicatesa previous exposure to HSV-1 butdoes not give any information of thetime point of an exposure. | The performance of this assay has notbeen established for matrices otherthan serum, or visual resultdetermination(s), or monitoring HSVtherapy. All results from this andother serologies must be correlatedwith clinical history, epidemiologicaldata, and other data available to theattending physician in evaluating thepatient. | |
| Results from the Elecsys HSV-1 IgGimmunoassay should be used inconjunction with the patient's medicalhistory and clinical symptoms. | The prevalence of infection will affectthe assay's predictive value. | |
| The results in HIV patients, in patientsundergoing immunosuppressivetherapy, or in patients with otherdisorders leading to immunesuppression, should be interpretedwith caution. | As with other serological tests,negative results do not rule out thediagnosis of herpes simplex disease. | |
| Specimens from neonates, cord blood,pretransplant patients or body fluidsother than serum and plasma, such asurine, saliva or amniotic fluid have notbeen tested. | The time required to seroconvertfollowing the primary infection varieswith the individual; the specimen mayhave been drawn prior to theappearance 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 theinfecting virus is gG deficient, or becauseit is unknown if the assay's antigen wasglycosylated the same as mammaliancells. |
| Criterion: Mean recovery of positivesamples within ± 20 % of serum value.Correct assignment of negative samplesand recovery of positive samples ± 20 %. | As with other serological tests, falsepositive results may occur. Repeat testingor testing with a different device may beindicated in some settings, e.g., patientswith a low likelihood of HSV infection. | |
| Samples should not be taken from patientsreceiving therapy with high biotin doses(i.e. > 5 mg/day) until at least 8 hoursfollowing the last biotin administration. | A single positive result only indicatesprevious immunologic exposure; level ofantibody response or class of antibodyresponse may not be used to determineactive infection or disease state. | |
| No interference was observed fromrheumatoid factors up to a concentrationof 1500 IU/mL. | The magnitude of the index value abovethe Cut-off does not indicate the totalamount of antibody present. | |
| In vitro tests were performed on 18commonly used pharmaceuticals and inaddition on Famciclovir, Aciclovir andValaciclovir. No interference with theassay was found. | Serology cannot distinguish genital fromoral infections. When appropriate, cultureis recommended to identify the infectionsite. However, false negative HSVcultures are common, especially inpatients with recurrent infection or withhealing lesions. | |
| Assay performance for sodium citrateplasma has not been evaluated. | ||
| Comparison of Assays-Similarities and Differences, continuedImmunoassay 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 toextremely high titers of antibodies tostreptavidin or ruthenium can occur.These effects are minimized by suitabletest design. | |
| Cross reactivity for HPV and varioustypes of bacterial vaginosis-causingagents (e.g., Mobiluncus spec,Gardnerella vaginalis, and Bacteroidesspec) were not evaluated in theperformance analysis of this assay. Theinfluence of the serological responseagainst any of these agents on the resultsof the Elecsys HSV-1 IgG immunoassayis unknown. | ||
| Sample stability studies were performedusing serum only.For diagnostic purposes, the resultsshould always be assessed in conjunctionwith the patient's medical history, clinicalexamination and other findings. |
Comparison of Assays-Similarities and Differences, continued
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510(k) Summary, Continued
mparison of Assays-ﺮ ﺍ Similarities and Differences, continued
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rison of Assays-Similarities and Differences, continued ﻟﺴﻴﺎﺳﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ --- -- -- --
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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 | ||
| PercentAgreement orSensitivity/Specificity | Expectant Mother Cohort (n=125)Positive Percent Agreement (95% CI):91.0% (82.4-96.3%)Negative Percent Agreement (95% CI):95.7% (85.5-99.5%) | Relative Sensitivities to Western BlotPregnant Cohort: 100%Sexually Active Adults: 99.3%Low Prevalence Population: 82.4% |
| Sexually Active Cohort (n=600)Positive Percent Agreement (95% CI):94.2% (91.3-96.4%)Negative Percent Agreement (95% CI):90.3% (85.9-93.8%) | Relative Specificity to Western BlotPregnant Cohort: 93.1%Sexually Active Adults: 95.1%Low Prevalence Population: 100% | |
| Low Prevalence Cohort (n=200)Positive Percent Agreement (95% CI):94.9% (87.4-98.6%)Negative Percent Agreement (95% CI):96.7% (91.8-99.1%) | ||
| Agreementwith CDCPanel | 100% | 100% |
Similarities and Diffe - - - -..............................................................................................................................................................................
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510(k) Summary, Continued
| Characteristic | PreciControl HSV(Candidate Device) | Predicate Device:Elecsys PreciControl Anti-CCP(K081338) |
|---|---|---|
| Intended Use | PreciControl HSV is used for qualitycontrol of the Elecsys HSV-1 IgGimmunoassay on the Elecsys and cobas eimmunoassay analyzers. | Elecsys PreciControl Anti-CCP is usedfor quality control of the Elecsys Anti-CCP immunoassay on the Elecsys andcobas e immunoassay analyzers. |
| Levels | Two | Two |
| Format | Lyophilized | Lyophilized |
| Matrix | Human serum negative for HSV-1 IgGantibodies | Human serum |
| AnalyteConcentration | PreciControl 1: ~0.30 COIPreciControl 2: ~4.00 COI | PreciControl 1: ~20 U/mLPreciControl 2: ~100 U/mL |
| Stability | Unopened:• Store at 2-8°C up to the statedexpiration dateReconstituted:• 2 - 8°C: 14 days• On the Elecsys 2010 and cobas e411 analyzers at 20-25°C: Up to 5hours• On the MODULAR ANALYTICSE170, cobas e 601, and cobas e 602analyzers: Up to 2 hours | Unopened:• Store at 2-8°C up to the statedexpiration dateReconstituted:• -20°C: 1 month (freeze only once)• On the analyzers at 20-25°C: Up to5 hours• After thawing: Use only once |
| Handling | Dissolve carefully the contents of onebottle by adding exactly 3.0 mL ofdistilled or deionized water and allow tostand closed for 15 minutes toreconstitute. Mix carefully, avoiding theformation of foam. Use a pipette totransfer the reconstituted control of 1bottle into empty labeled Elecsys snap-cap bottles supplied. | Dissolve carefully the contents of onebottle by adding exactly 2.0 mL ofdistilled water and allow to standclosed for 15 minutes to reconstitute.Mix carefully, avoiding the formationof foam. Transfer aliquots of thefreshly reconstituted controls intoappropriate tubes for storage. Store thealiquots immediately at -20°C. |
Comparison of Controls – Similarities and Differences
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/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 symbol resembling an eagle or bird with three stylized human profiles forming its body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 25 2012
Roche Diagnostics c/o Ms. K. Colleen Adams, MTSC Regulatory Affairs Principal 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250-0146
Re: K120625
Trade/Device Name: Elecsys HSV-1 IgG Immunoassay and PreciControl HSV Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MXJ, JJX Dated: June 25, 2012 Received: June 26, 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
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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 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,
Uke Self for
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
Elecsys HSV-1 IgG Immunoassay Device Name:
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 lithiumheparin 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.
This test is not FDA-cleared for screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonates, immunocompromised patients, or for use at point-of-care facilities.
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 (OLVD)
I ama a let de Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety
510(k) K/20625
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Indications for Use
PreciControl HSV Device Name:
Indications For Use: PreciControl HSV is used for quality control of the Elecsys HSV-1 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)
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Office of In Vitro Diagnostic Device Evaluation and Safety
k 12 0625 510(k).
§ 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).