(270 days)
Elecsys CMV IgG:
The Elecsys CMV IgG immunoassay is a test for the in vitro semi-quantitative determination of IgG class antibodies to CMV in human serum, lithium-heparin plasma, K2 -EDTA plasma, and K3 -EDTA plasma. The test is intended for adults, including expectant mothers, as an aid in presumptive diagnosis of CMV infection. Results with this assay are used to indicate past infection with CMV.
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 CMV IgG:
Elecsys PreciControl CMV IgG is used for quality control of the Elecsys CMV IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
(1) Elecsys CMV IgG is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated recombinant CMV-specific antigen labeled with a ruthenium complex and electrochemiluminescence detection. The results are determined using a calibration curve which is instrument-specifically generated by a 2-point calibration and a master curve provided via the reagent bar code. Results greater than or equal to 1.0 U/mL are considered reactive CMV IgG antibody. The test system contains the human serum-based calibrators intended for use with the system.
(2) Elecsys PreciControl CMV IgG contains liquid control serum based on human serum. The controls are used for monitoring the accuracy of the Elecsys CMV IgG immunoassay.
Note: The reagent and calibrators are packaged together in the Elecsys CMV IgG assay kit, while the associated PreciControl is packaged separately.
The Elecsys CMV IgG Test System was evaluated through a clinical trial to demonstrate its performance characteristics.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys CMV IgG Immunoassay are not explicitly stated as numerical targets in the provided text. Instead, the study reports the "Percent Agreement" values (often referred to as sensitivity and specificity for agreement studies) against a reference method (the predicate device, Diamedix Is-CMV IgG).
| Performance Metric | Acceptance Criteria (Not explicitly stated in document. Based on typical agreement expectations for such assays, good agreement with a predicate is generally sought, e.g., >90%) | Reported Device Performance (Elecsys CMV IgG) | Predicate Device Performance (Diamedix Is-CMV IgG) |
|---|---|---|---|
| Routine Cohort (n=500) | |||
| Positive Percent Agreement (95% CI) | N/A (implied high agreement) | 100% (98.7-100%) | See "Relative Sensitivities" below |
| Negative Percent Agreement (95% CI) | N/A (implied high agreement) | 90.1% (85.3-93.7%) | See "Relative Specificities" below |
| Expectant Mother Cohort (n=98) | |||
| Positive Percent Agreement (95% CI) | N/A (implied high agreement) | 100% (95.4-100%) | Not explicitly provided for this cohort |
| Negative Percent Agreement (95% CI) | N/A (implied high agreement) | 73.7% (48.8-90.9%) | Not explicitly provided for this cohort |
| CMV IgM Positive Cohort (n=119) | |||
| Positive Percent Agreement (95% CI) | N/A (implied high agreement) | 96.6% (91.6-99.1%) | Not explicitly provided for this cohort |
| Negative Percent Agreement (95% CI) | N/A (implied high agreement) | 100% (2.5-100%) | Not explicitly provided for this cohort |
| Predicate Device (Diamedix Is-CMV IgG) relative to EIA (Manual) | |||
| Relative Sensitivities (Site 1, n=195) | N/A | - | 99.3% (96.3-100.0%) |
| Relative Sensitivities (Site 2, n=168) | N/A | - | 96.6% (91.5-99.1%) |
| Relative Sensitivities (Site 3, n=205) | N/A | - | 100.0% (97.6-100.0%) |
| Relative Specificities (Site 1, n=195) | N/A | - | 97.9% (88.9-99.9%) |
| Relative Specificities (Site 2, n=168) | N/A | - | 100.0% (93.0-100.0%) |
| Relative Specificities (Site 3, n=205) | N/A | - | 94.3% (84.3-98.8%) |
| Predicate Device (Diamedix Is-CMV IgG) relative to EIA (Automated) | |||
| Relative Sensitivities (Site 3, n=201) | N/A | - | 100.0% (97.6-100.0%) |
| Relative Specificities (Site 3, n=201) | N/A | - | 87.7% (75.2-95.4%) |
2. Sample Size and Data Provenance
The study included several cohorts for performance evaluation:
- Routine Cohort: n=500
- Expectant Mother Cohort: n=98
- CMV IgM Positive Cohort: n=119
- Cross-Reactivity Cohort: 249 samples positive for various cross-reactants.
The document does not specify the country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of human experts or their qualifications for establishing ground truth for the clinical trial comparing the Elecsys CMV IgG immunoassay with the predicate device. The performance is assessed based on agreement with the predicate device results.
4. Adjudication Method
No adjudication method is mentioned in the provided text, as the comparison is made directly against the predicate device's results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study involving human readers with and without AI assistance was performed, as this device is an in vitro diagnostic immunoassay, not an AI software intended for human interpretation assistance.
6. Standalone Performance (Algorithm Only)
Yes, a standalone study was performed. The Elecsys CMV IgG Immunoassay's performance metrics (Positive Percent Agreement, Negative Percent Agreement) were directly evaluated against the predicate device's results in various clinical cohorts, representing its standalone performance. Additional analytical performance characteristics like precision, LoB/LoD, hook effect, and cross-reactivity were also evaluated for the Elecsys CMV IgG assay itself.
7. Type of Ground Truth Used
The ground truth for the clinical performance evaluation appears to be established by the results of the predicate device, the Diamedix Is-CMV IgG Test System (K981163). The study reports "Percent Agreement" with this predicate device. For the cross-reactivity study, the ground truth was the known positive status for specific cross-reactants.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an algorithm or machine learning model for the Elecsys CMV IgG Immunoassay. This device is an immunoassay, and its development likely involves laboratory optimization and validation studies, rather than machine learning training sets. Therefore, a sample size for a training set is not applicable or provided.
9. How the Ground Truth for the Training Set was Established
As noted in point 8, the concept of a "training set" and associated ground truth establishment is not typically applicable to the development of an immunoassay like the Elecsys CMV IgG Test System. The document describes standard laboratory validation procedures and clinical performance evaluation against a predicate device.
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Elecsys CMV IgG Test System
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | |
|---|---|---|
| SubmitterName, Address,Contact | Roche Diagnostics9115 Hague RoadP.O. Box 50416Indianapolis, IN 46250-0416Phone: (317) 521-3577Fax: (317) 521-2425Email: colleen.adams@roche.comContact Person: K. Colleen Adams, Manager US Regulatory AffairsDate Prepared: May 31, 2013 | |
| Device Name | Proprietary name: | (1) Elecsys CMV IgG Immunoassay(2) Elecsys PreciControl CMV IgG |
| Common name: | (1) CMV IgG(2) PreciControl CMV IgG | |
| Classification name: | (1) Enzyme linked immunoabsorbent assay,cytomegalovirus(2) Single (specified) analyte controls (assayed andunassayed) | |
| Product Code: | (1) LFZ(2) JJX | |
| Predicate Device: | (1) Diamedix Is-CMV IgG (K981163)(2) Elecsys PreciControl Rubella IgG (K072617) | |
| DeviceDescription | (1) Elecsys CMV IgG is a two-step sandwich immunoassay with streptavidinmicroparticles, biotinylated recombinant CMV-specific antigen labeled with aruthenium complex and electrochemiluminescence detection. The results aredetermined using a calibration curve which is instrument-specificallygenerated by a 2-point calibration and a master curve provided via the reagentbar code. Results greater than or equal to 1.0 U/mL are considered reactiveCMV IgG antibody. The test system contains the human serum-basedcalibrators intended for use with the system. | |
| (2) Elecsys PreciControl CMV IgG contains liquid control serum based onhuman serum. The controls are used for monitoring the accuracy of the ElecsysCMV IgG immunoassay. | ||
| Note: The reagent and calibrators are packaged together in the Elecsys CMVIgG assay kit, while the associated PreciControl is packaged separately. | ||
| IntendedUse/Indicationsfor Use | Elecsys CMV IgG:The Elecsys CMV IgG immunoassay is a test for the in vitro semi-quantitativedetermination of IgG class antibodies to CMV in human serum, lithium-heparin plasma, K2 -EDTA plasma, and K3 -EDTA plasma. The test isintended for adults, including expectant mothers, as an aid in presumptivediagnosis of CMV infection. Results with this assay are used to indicate pastinfection with CMV. | |
| The electrochemiluminescence immunoassay "ECLIA" is intended for use onthe 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 pediatricpopulation, neonates and immunocompromised patients or for use at point ofcare facilities. | ||
| Elecsys PreciControl CMV IgG:Elecsys PreciControl CMV IgG is used for quality control of the Elecsys CMVIgG immunoassay on the Elecsys and cobas e immunoassay analyzers. | ||
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| SubstantialEquivalence | The Elecsys CMV IgG immunoassay test system is substantially equivalent toother devices legally marketed in the United States. | |
| (1) Elecsys CMV IgG Immunoassay is equivalent to Is-CMV IgG Test System,Diamedix Corporation (K981163). | ||
| (2) Elecsys PreciControl CMV IgG is equivalent to the Elecsys PreciControlRubella IgG (K072617). | ||
| SubstantialEquivalence -Comparison | The following tables compare the Elecsys CMV IgG immunoassay andPreciControl CMV IgG with their respective predicate devices. | |
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| Comparison of Assays—Similarities and Differences | ||
|---|---|---|
| Immunoassay Comparison | ||
| Feature | Elecsys HSV-2 IgG Reagent andCalibrator(Candidate Device) | Is-CMV IgG Test System(Predicate Device: K981163) |
| General Assay Features | ||
| IntendedUse/Indicationsfor Use | The Elecsys CMV IgG immunoassayis a test for the in vitro semi-quantitative determination of IgGclass antibodies to CMV in humanserum, lithium-heparin plasma, K2 -EDTA plasma, and K3 -EDTA plasma.The test is intended for adults,including expectant mothers, as an aidin presumptive diagnosis of CMVinfection. Results with this assay areused to indicate past infection withCMV. | For the qualitative and semi-quantitative detection of IgGantibodies to cytomegalovirus (CMV)in human serum by indirect enzymeimmunoassay to aid in the assessmentof the patient's immunologicalresponse to CMV and to determine theimmune status of individuals,including females of child-bearingage. The evaluation of acute andconvalescent sera can aid in thediagnosis of primary infection,reactivated infection or reinfectionwith CMV. This product is not FDAcleared for use in screening blood andplasma donors. |
| AssayProtocol | Sandwich assay | Solid phase microtiter |
| DetectionProtocol | ElectrochemiluminescentImmunoassay | Enzyme-linked immunosorbent assay |
| Applications | 18 minutes | N/A |
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| Comparison of Assays—Similarities and DifferencesImmunoassay Comparison | ||
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| Feature | Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) |
| General Assay Features | ||
| InstrumentPlatform | Elecsys 2010, MODULARANALYTICS E170, cobas e 411,cobas e 601, and cobas e 602 | Automated EIA Processor or Manual |
| SampleVolume | 20 μL | 100 μL after dilution |
| SampleType | Human serum and Lithium-heparin,K2-EDTA, and K3-EDTA plasma | Human whole blood and serum |
| Reagents | Reagents consist of streptavidin-coated microparticles, biotinylatedCMV antigen (recombinant, from E.coli), ruthenylated CMV antigen(recombinant, from E. coli), andnegative and positive calibrators. | Reagents consist of partially purifiedCMV antigen (AD-169 strainproduced in human fibroblasts)coating the antigen wells. |
| Calibrator | Included with the reagent kit | Included in the reagent kit asDiamedix CMV IgG Standards |
| CalibrationInterval | Calibration must be performed onceper reagent lot using fresh reagent(i.e. not more than 24 hours sincethe reagent kit was registered on theanalyzer). Renewed calibration isrecommended as follows:• After 27 days when using thesame reagent lot.• After 7 days when using thesame reagent kit on the analyzer.• As required: e.g. quality controlfindings with PreciControl CMVIgG outside the defined limits. | Calibration, using Diamedix CMVIgG Standards, occurs with each useof the antigen wells. |
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| Comparison of Assays-Similarities and Differences, continued | |||
|---|---|---|---|
| Immunoassay Comparison | |||
| Feature | Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) | |
| General Assay Features | |||
| Controls | Elecsys PreciControl CMV IgG | High positive, low positive, andnegative controls included in thereagent kit | |
| Traceability /Standardization | The Elecsys CMV IgG assay hasbeen standardized against the Rocheinternal standard for CMV IgG. Nointernational standard is availablefor CMV. | The Diamedix CMV IgG "Standards"(calibrators) are traceable to in-housereference materials and not to anyrecognized national or internationalstandard preparation. | |
| ReagentStability | Reagents (ready to use):• 2-8°C -- Up to the statedexpiration date• After opening at 2-8°C - 12weeks• On the analyzers - 4 weeksCalibrators (ready to use):• Unopened at 2-8°C - Up to statedexpiration date• After opening at 2-8°C - 8 weeks• On the Elecsys 2010 and cobas e411 20-25°C - Up to 5 hours• On the MODULARANALYTICS E170, cobas e 601,and cobas e 602 - Use only once | Kits and reagents are stable throughtheir expiration dates when stored at 2-8°C. | |
| Results | The analyzer automaticallycalculates the analyte concentrationof each sample in U/mL. | Positive, equivocal, or negative resultsare generated by this assayautomatically when utilizing theAutomated EIA Processor. |
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| Immunoassay Comparison | ||
|---|---|---|
| Feature | Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) |
| General assay features | ||
| ResultInterpretation | Results obtained with the ElecyssCMV IgG assay can be interpretedas follows:Non-reactive: < 0.5 U/mL Indeterminate: 0.5 - < 1.0 U/mL Reactive: ≥ 1.0 U/mL | Results of this test are negative,equivocal, or positive for anti-CMVIgG, as defined below:Negative - <8.0 EU/mL, Index < 0.80 Equivocal - 8.0 to 9.9 EU/mL, Index 0.8 to 0.99 Positive - ≥ 10.0 EU/mL, Index ≥ 1.0 |
| Limits of | LoB = 0.15 U/mL | Not applicable |
| Measurement | LoD = 0.25 U/mL | |
| Hook Effect | No hook effect up to 2500 U/mL | Not tested |
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| Immunoassay Comparison | ||
|---|---|---|
| Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) | |
| Feature | ||
| Labeled Performance Characteristics | ||
| Precision | Elecsys 2010 and cobas e 411Intra-assay/Repeatability:• Negative Control: SD 0.004U/mL• Low Control: CV 0.9 - 1.6%• High Control: CV 0.7 - 1.4%• Serum Samples < 1.0 U/mL:CV 1.5 - 1.9%• Serum Samples ≥ 1.0 U/mL:CV 1.2 - 1.5%Intermediate Precision:• Negative Control: SD 0.005U/mL• Low Control: CV 3.2 - 3.3%• High Control: CV 3.1 - 3.3%• Serum Samples < 1.0 U/mL:CV 3.2 - 3.4%• Serum Samples ≥ 1.0 U/mL:CV 2.6 - 3.9% | Manual PreparationIntra-assay/Repeatability:• Negative Control: SD 0.12 - 0.31EU/mL• Low Control: CV 5.23 - 10.78%• High Control: CV 2.46 - 12.07%• Serum Samples < 10.0 EU/mL:SD 0.26 - 2.12 EU/mL• Serum Samples ≥ 10.0 EU/mL:CV 1.03 - 13.90%Intermediate Precision:• Negative Control: SD 0.25 - 0.45EU/mL• Low Control: CV 7.10 - 8.76%• High Control: CV 3.41 - 11.00%• Serum Samples < 10.0 EU/mL:SD 0.31 - 2.44 EU/mL• Serum Samples ≥ 10.0 EU/mL:CV 4.37 - 21.33% |
| E170, cobas e 601, and cobas e 602Intra-assay/Repeatability:• Negative Control: SD 0.003U/mL• Low Control: CV 1.0 - 2.0%• High Control: CV 1.1 - 1.6%• Serum Samples < 1.0 U/mL:CV 1.7%• Serum Samples ≥ 1.0 U/mL:CV 1.2 - 2.0% | Automated PreparationIntra-assay/Repeatability:• Negative Control: SD 0.70 EU/mL• Low Control: CV 5.05%• High Control: CV 8.38%• Serum Samples < 10.0 EU/mL:SD 0.43 - 0.56 EU/mL• Serum Samples ≥ 10.0 EU/mL:CV 5.39 - 18.07% |
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| Immunoassay Comparison | ||
| Feature | Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) |
| Labeled Performance Characteristics | ||
| Precision(continued) | Intermediate Precision:• Negative Control: SD 0.004U/mL• Low Control: CV 3.2 - 4.2%• High Control: CV 3.7 - 4.2%• Serum Samples < 1.0 U/mL:CV 4.0%• Serum Samples ≥ 1.0 U/mL:CV 3.2 - 4.5% | Intermediate Precision:• Negative Control: SD 0.71 EU/mL• Low Control: CV 8.77%• High Control: CV 6.68%• Serum Samples < 10.0 EU/mL:SD 0.54-0.74 EU/mL• Serum Samples ≥ 10.0 EU/mL:CV 9.43 - 15.46% |
| Cross-Reactivity | 249 samples, which were positivefor the following cross reactants,were tested with the Elecsys CMVIgG and the predicate device:Autoimmune, EBV, E.Coli, HAV,HBV, HCV, HIV, HSV, HTLV,influenza vaccine, rubella, syphilis,and toxoplasmosis. 98.9%agreement was demonstratedbetween the two assays. | The sponsor tested 47 CMV IgG-negative samples which were positivefor at least one of the followingcrossreactants: VZV IgG, HSV,toxoplasmosis, rubella, EBV, andmeasles. No cross-reactivity wasobserved. |
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| Immunoassay Comparison | ||
|---|---|---|
| Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) | |
| Labeled Performance Characteristics | ||
| Feature | ||
| Limitations | A negative test result does notcompletely rule out the possibilityof an infection with CMV.Individuals may not exhibit anydetectable IgG antibodies at theearly stage of acute infection. The detection of CMV-specificIgG antibodies in a single sampleindicates a previous exposure toCMV but is not always sufficientto distinguish between an acute orlatent infection (irrespective ofthe level of the IgG antibodytiter). In rare cases of primary CMVinfection IgG antibody may bepresent before a specific IgMantibody response is detected. It isrecommended that a follow-upsample be tested after 2 weeks. Ifthe CMV IgG antibody titerremains stable, a primaryinfection can be excluded. Elecsys CMV IgG results shouldbe used in conjunction with thepatient's medical history, clinicalsymptoms and other laboratorytests, e.g. CMV-specific IgM | The results obtained with the Is-CMV IgG Test Kit serve only as anaid to diagnosis and should not beinterpreted as diagnostic inthemselves. Assay performance characteristicshave not been established for visualresult determination. The test should be performed onserum. The use of whole blood orplasma has not been established. The presence of IgG antibodies in asingle serum sample is notsufficient to distinguish betweenactive and past infection. A test forIgM antibodies may be performedfor patients suspected of primaryinfection with CMV. Performance of this assay has notbeen established onspectrophotometry utilizing a singlewavelength. The performance characteristicshave not been established forprenatal populations or newborns. The results on serum fromimmunosuppressed individualsmust be interpreted with caution. |
| Immunoassay Comparison | ||
| Feature | Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) |
| Limitations, continued | 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. 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. There is no high-dose hook effect at CMV IgG concentrations up to 2500 U/mL. The assay is unaffected by icterus (bilirubin < 1129 µmol/L or < 66 mg/dL), hemolysis (Hb < 1000 mg/dL), lipemia (Intralipid < 2000 mg/dL), biotin (< 100 ng/mL) and human serum albumin (< 20 g/dL). Criterion: Mean recovery of positive samples within ± 20 % of serum value. 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. No interference was observed from rheumatoid factors up to a concentration of 1600 IU/mL. | Studies demonstrating the effectiveness or monitoring of antiviral treatments have not been performed. Definitive diagnosis of active CMV infection requires viral isolation. The presence of IgG antibody to CMV does not ensure protection from the disease. The performance characteristics of the Diamedix Is-CMV IgG Test Kit with automated equipment other than the MAGO® Plus Automated EIA Processor have not been established. |
| Comparison of Assays—Similarities and Differences, continued | ||
| Immunoassay Comparison | ||
| Feature | Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) |
| Labeled Performance Characteristics | ||
| Limitations,continued | In vitro tests were performed on18 commonly usedpharmaceuticals and in additionon ganciclovir and valganciclovir.No interference with the assaywas found. In rare cases, interference due toextremely high titers of antibodiesto immunological components,streptavidin or ruthenium canoccur. These effects areminimized by suitable test design. For diagnostic purposes, theresults should always be assessedin conjunction with the patient'smedical history, clinicalexamination and other findings. |
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| Immunoassay Comparison | ||
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| Feature | Elecsys CMV IgG Reagent andCalibrator(Candidate Device) | Diamedix Is-CMV IgG(Predicate Device: K981163) |
| Labeled Performance Characteristics | ||
| PercentAgreement/RelativeSensitivities andSpecificities | Routine Cohort (n=500)Positive Percent Agreement (95% CI):100% (98.7-100%)Negative Percent Agreement (95% CI):90.1% (85.3-93.7%)Expectant Mother Cohort (n=98)Positive Percent Agreement (95% CI):100% (95.4-100%)Negative Percent Agreement (95% CI):73.7% (48.8-90.9%)CMV IgM Positive Cohort (n=119)Positive Percent Agreement (95% CI):96.6% (91.6-99.1%)Negative Percent Agreement (95% CI):100% (2.5-100%) | Relative Sensitivities to EIAManual (95%CI)Site 1 (n=195): 99.3% (96.3-100.0%)Site 2 (n=168): 96.6% (91.5-99.1%)Site 3 (n=205): 100.0% (97.6-100.0%)Relative Sensitivities to EIAAutomated (95% CI)Site 3 (n=201): 100.0% (97.6-100.0%)Relative Specificities to EIAManual (95% CI)Site 1 (n=195): 97.9% (88.9-99.9%)Site 2 (n=168): 100.0% (93.0-100.0%)Site 3 (n=205): 94.3% (84.3-98.8%)Relative Specificities to EIAAutomated (95% CI)Site 3 (n=201): 87.7% (75.2-95.4%) |
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| Characteristic | Elecsys PreciControl CMV IgG(Candidate Device) | Predicate Device:Elecsys PreciControl Rubella IgG(K072617) |
|---|---|---|
| Intended Use | PreciControl CMV IgG is used for thequality control of the Elecsys CMV IgGimmunoassay on the Elecsys and cobas eimmunoassay analyzers. | Elecsys PreciControl Rubella IgG isused for quality control of the ElecsysRubella IgG immunoassay on theElecsys and cobas e immunoassayanalyzers. |
| Levels | Three | Two |
| Format | Liquid, ready for use | Liquid, ready for use |
| Matrix | Human serum | Human serum |
| AnalyteConcentration | PreciControl 0: <0.25 U/mLPreciControl 1: ~1.5 U/mLPreciControl 2: ~25 U/mL | PreciControl 1: ~4.0 IU/mLPreciControl 2: ~75 IU/mL |
| Stability | Unopened:• Store at 2-8°C up to the statedexpiration dateOpened:• 2 - 8°C: 8 weeks• On the Elecsys 2010 and cobas e411 analyzers at 25°C: Up to 5hours• On the MODULAR ANALYTICSE170, cobas e 601, and cobas e 602analyzers 25°C: Up to 2 hours | Unopened:• Store at 2-8°C up to the statedexpiration dateOpened:• 2 - 8°C: 8 weeks• On the analyzer at 20-25°C: Upto 5 hours |
| Handling | The controls are supplied ready-for-use inbottles compatible with the system. Whenmeasuring non-Roche controls, use onlyrecommended sample tubes, cup on tubeor cup on rack.Elecsys 2010 and cobas e 411 analyzers:The original control vials may be used ifthe entire provided volume is used and noaliquots are prepared.The controls should only be left on theanalyzer during performance of qualitycontrol. After use, close the bottles assoon as possible and store upright at 2-8°C. Due to possible evaporation effects,not more than 7 quality controlprocedures per bottle should beperformed. | The controls are supplied ready-for-usein bottles compatible with the system.The controls should only be left on theanalyzer during performance of qualitycontrol. After use, close the bottles assoon as possible and store upright at 2-8°C.Because of possible evaporationeffects, not more than 7 quality controlprocedures per bottle should beperformed. |
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510(k) Summary, Continued
| EvaluationsSummary | (1) The Elecsys CMV IgG Immunoassay was evaluated for severalperformance characteristics, including precision, LoB and LoD, high dosehook effect, cross reactivity, method comparison between analyzer platforms,interfering substances, and reagent, calibration, and sample stability. |
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| (2) The Elecsys PreciControl HSV was evaluated for value assignment andstability. | |
| A summary of the evaluation studies is provided in Section IV. | |
| Additionally, the Elecsy CMV IgG assay was evaluated in a clinical trialusing an adult cohort that included specimens from pregnant subjects andCMV IgM-positive subjects. |
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Analytical Performance Characteristics
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
ROCHE DIAGNOSTICS JANE PHILIPS, Ph.D. REGULATORY AFFAIRS PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS IN, 46250
Re: K131605
Trade/Device Name: Elecsys CMV IgG Assay and Elecsys PreciControl CMV IgG Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: II Product Code: LFZ, JJX Dated: January 28, 2014 Received: January 29, 2014
Dear Dr. Philips:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Stephen J. Lovell -S for
Sally A. Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
1
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Indications for Use Form
510(k) Number (if known): K 131605
Device Name: Elecsys CMV IgG Assay
Indications for Use:
The Elecsys CMV IgG assay is an in vitro qualitative test for the detection of IgG antibodies to CMV in human serum, lithium-heparin plasma. K2-EDTA plasma. and K3-EDTA plasma. The test is intended as an aid in the determination of the serological status to CMV in individuals in which a CMV IgG test was ordered, including pregnant women.
Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This test is not intended for use in screening blood and plasma donors. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Device Name: Elecsys PreciControl CMV 1gG
Indications for Use:
Elecsys PreciControl CMV IgG is used for quality control of the Elecsys CMV 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 Center for Devices and Radiological Health (CDRH)
Stephen J. Lovell -S 2014.02.28 10:00:25 -05'00'
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).