Who is the manufacturer of ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY?

Roche Diagnostics filed the 510(k) submission for ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY (K131605).

What is the FDA product code for ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY?

LFZ. It is classified under 21 CFR 866.3175 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY?

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

What are the predicate devices for ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY?

Is-CMV IgG Test System (K981163).

Who can help prepare an FDA 510(k) submission like ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY?

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

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

K131605 · Roche Diagnostics · LFZ · Feb 28, 2014 · Microbiology

Device Facts

Record ID	K131605
Device Name	ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
Applicant	Roche Diagnostics
Product Code	LFZ · Microbiology
Decision Date	Feb 28, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3175
Device Class	Class 2

Intended 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. Elecsys PreciControl CMV IgG is used for quality control of the Elecsys CMV IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys CMV IgG is a two-step sandwich immunoassay using electrochemiluminescence (ECLIA) to detect IgG antibodies to CMV. Input: human serum or plasma (lithium-heparin, K2-EDTA, K3-EDTA). Process: biotinylated recombinant CMV-specific antigen and ruthenium-labeled CMV antigen bind to antibodies in sample; streptavidin-coated microparticles capture the complex. Analyzer triggers ECLIA; signal intensity correlates to antibody concentration. Output: semi-quantitative concentration in U/mL. Used in clinical laboratories on Elecsys/cobas e analyzers by trained technicians. Results aid clinicians in diagnosing past CMV infection. Benefits: automated, standardized, high-throughput testing for CMV serological status.

Clinical Evidence

Multi-center U.S. study (n=605) comparing Elecsys CMV IgG to a predicate device. Population included patients with ordered CMV IgG tests (n=400) and pregnant women (n=205). Results for the general population showed 98.94% positive agreement (95% CI: 96.93-99.78%) and 92.86% negative agreement (95% CI: 89.47-95.42%). Pregnant population showed 96.55% positive agreement (95% CI: 90.25-99.28%) and 100% negative agreement (95% CI: 96.92-100.00%).

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection. Reagents: streptavidin-coated microparticles, biotinylated recombinant CMV antigen, ruthenium-labeled recombinant CMV antigen. Platform: Elecsys/cobas e immunoassay analyzers. Sample volume: 20 μL. Calibration: 2-point, master curve via reagent barcode. Stability: 2-8°C storage; 4-week on-analyzer stability.

Indications for Use

Indicated for individuals in whom a CMV IgG test is ordered, including pregnant women, to determine serological status to CMV. Not for use in immunocompromised/immunosuppressed individuals, neonatal screening, point-of-care, or blood/plasma donor screening.

Regulatory Classification

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.

Predicate Devices

Is-CMV IgG Test System (K981163)

Related Devices

K220911 — Elecsys CMV IgG · Roche Diagnostics · Oct 12, 2022
K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control · Siemens Healthcare Diagnostics, Inc. · Jul 30, 2018
K981163 — DIAMEDIX IS-CMV IGG TEST SYSTEM · Diamedix Corp. · Sep 21, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ K131605 FEB 2 8 2014 Elecsys CMV IgG Test System ## 510(k) Summary | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------| | Submitter Name, Address, Contact | Roche Diagnostics 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416 Phone: (317) 521-3577 Fax: (317) 521-2425 Email: colleen.adams@roche.com Contact Person: K. Colleen Adams, Manager US Regulatory Affairs Date 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 and unassayed) | | | Product Code: | (1) LFZ (2) JJX | | | Predicate Device: | (1) Diamedix Is-CMV IgG (K981163) (2) Elecsys PreciControl Rubella IgG (K072617) | | Device Description | (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. | | | Intended Use/Indications for Use | 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. | | | | Continued on next page | | | | | | | Substantial Equivalence | The Elecsys CMV IgG immunoassay test system is substantially equivalent to other 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 PreciControl Rubella IgG (K072617). | | | Substantial Equivalence - Comparison | The following tables compare the Elecsys CMV IgG immunoassay and PreciControl CMV IgG with their respective predicate devices. | | | | Continued on next page | | Continued on next page {1}------------------------------------------------ ## 510(k) Summary, Continued Confidential . {2}------------------------------------------------ ## 510(k) Summary, Continued 1 のお気になる。 {3}------------------------------------------------ ## 510(k) Summary, Continued | Comparison of Assays—Similarities and Differences | | | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Immunoassay Comparison | | | | Feature | Elecsys HSV-2 IgG Reagent and Calibrator (Candidate Device) | Is-CMV IgG Test System (Predicate Device: K981163) | | | General Assay Features | | | Intended Use/ Indications for Use | 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. | For the qualitative and semi- quantitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of primary infection, reactivated infection or reinfection with CMV. This product is not FDA cleared for use in screening blood and plasma donors. | | Assay Protocol | Sandwich assay | Solid phase microtiter | | Detection Protocol | Electrochemiluminescent Immunoassay | Enzyme-linked immunosorbent assay | | Applications | 18 minutes | N/A | #### : a nice {4}------------------------------------------------ | Comparison of Assays—Similarities and Differences Immunoassay Comparison | | | |-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys CMV IgG Reagent and Calibrator (Candidate Device) | Diamedix Is-CMV IgG (Predicate Device: K981163) | | General Assay Features | | | | Instrument Platform | Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, cobas e 601, and cobas e 602 | Automated EIA Processor or Manual | | Sample Volume | 20 μL | 100 μL after dilution | | Sample Type | Human serum and Lithium-heparin, K2-EDTA, and K3-EDTA plasma | Human whole blood and serum | | Reagents | Reagents consist of streptavidin- coated microparticles, biotinylated CMV antigen (recombinant, from E. coli), ruthenylated CMV antigen (recombinant, from E. coli), and negative and positive calibrators. | Reagents consist of partially purified CMV antigen (AD-169 strain produced in human fibroblasts) coating the antigen wells. | | Calibrator | Included with the reagent kit | Included in the reagent kit as Diamedix CMV IgG Standards | | Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Renewed calibration is recommended as follows: • After 27 days when using the same reagent lot. • After 7 days when using the same reagent kit on the analyzer. • As required: e.g. quality control findings with PreciControl CMV IgG outside the defined limits. | Calibration, using Diamedix CMV IgG Standards, occurs with each use of the antigen wells. | and the same of the same of the same of the same Continued on next page {5}------------------------------------------------ | Comparison of Assays-Similarities and Differences, continued | | | | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Immunoassay Comparison | | | | | Feature | Elecsys CMV IgG Reagent and Calibrator (Candidate Device) | Diamedix Is-CMV IgG (Predicate Device: K981163) | | | | General Assay Features | | | | Controls | Elecsys PreciControl CMV IgG | High positive, low positive, and negative controls included in the reagent kit | | | Traceability / Standardization | The Elecsys CMV IgG assay has been standardized against the Roche internal standard for CMV IgG. No international standard is available for CMV. | The Diamedix CMV IgG "Standards" (calibrators) are traceable to in-house reference materials and not to any recognized national or international standard preparation. | | | Reagent Stability | Reagents (ready to use): • 2-8°C -- Up to the stated expiration date • After opening at 2-8°C - 12 weeks • On the analyzers - 4 weeks Calibrators (ready to use): • Unopened at 2-8°C - Up to stated expiration date • After opening at 2-8°C - 8 weeks • On the Elecsys 2010 and cobas e 411 20-25°C - Up to 5 hours • On the MODULAR ANALYTICS E170, cobas e 601, and cobas e 602 - Use only once | Kits and reagents are stable through their expiration dates when stored at 2- 8°C. | | | Results | The analyzer automatically calculates the analyte concentration of each sample in U/mL. | Positive, equivocal, or negative results are generated by this assay automatically when utilizing the Automated EIA Processor. | | # : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {6}------------------------------------------------ ## Comparison of Assays—Similarities and Differences, continued | Immunoassay Comparison | | | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Elecsys CMV IgG Reagent and Calibrator (Candidate Device) | Diamedix Is-CMV IgG (Predicate Device: K981163) | | General assay features | | | | Result Interpretation | Results obtained with the Elecyss CMV IgG assay can be interpreted as 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-CMV IgG, 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 | Continued on next page and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the con {7}------------------------------------------------ | Immunoassay Comparison | | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Elecsys CMV IgG Reagent and Calibrator (Candidate Device) | Diamedix Is-CMV IgG (Predicate Device: K981163) | | Feature | | | | | Labeled Performance Characteristics | | | Precision | Elecsys 2010 and cobas e 411 Intra-assay/Repeatability: • Negative Control: SD 0.004 U/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 0.005 U/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 Preparation Intra-assay/Repeatability: • Negative Control: SD 0.12 - 0.31 EU/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 - 0.45 EU/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 602 Intra-assay/Repeatability: • Negative Control: SD 0.003 U/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 Preparation Intra-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% | #### Comparison of Assays—Similarities and Differences, continued {8}------------------------------------------------ | Comparison of Assays—Similarities and Differences, continued | | | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Immunoassay Comparison | | | | Feature | Elecsys CMV IgG Reagent and Calibrator (Candidate Device) | Diamedix Is-CMV IgG (Predicate Device: K981163) | | Labeled Performance Characteristics | | | | Precision (continued) | Intermediate Precision: • Negative Control: SD 0.004 U/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 positive for the following cross reactants, were tested with the Elecsys CMV IgG and the predicate device: Autoimmune, EBV, E.Coli, HAV, HBV, HCV, HIV, HSV, HTLV, influenza vaccine, rubella, syphilis, and toxoplasmosis. 98.9% agreement was demonstrated between the two assays. | The sponsor tested 47 CMV IgG- negative samples which were positive for at least one of the followingcross reactants: VZV IgG, HSV, toxoplasmosis, rubella, EBV, and measles. No cross-reactivity was observed. | #### Comparison of Assays—Similarities and Differences, continued Continued on next page {9}------------------------------------------------ | Immunoassay Comparison | | | |-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Elecsys CMV IgG Reagent and Calibrator (Candidate Device) | Diamedix Is-CMV IgG (Predicate Device: K981163) | | | Labeled Performance Characteristics | | | | Feature | | | | Limitations | A negative test result does not completely rule out the possibility of an infection with CMV. Individuals may not exhibit any detectable IgG antibodies at the early stage of acute infection. The detection of CMV-specific IgG antibodies in a single sample indicates a previous exposure to CMV but is not always sufficient to distinguish between an acute or latent infection (irrespective of the level of the IgG antibody titer). In rare cases of primary CMV infection IgG antibody may be present before a specific IgM antibody response is detected. It is recommended that a follow-up sample be tested after 2 weeks. If the CMV IgG antibody titer remains stable, a primary infection can be excluded. Elecsys CMV IgG results should be used in conjunction with the patient's medical history, clinical symptoms and other laboratory tests, e.g. CMV-specific IgM | The results obtained with the Is- CMV IgG Test Kit serve only as an aid to diagnosis and should not be interpreted as diagnostic in themselves. Assay performance characteristics have not been established for visual result determination. The test should be performed on serum. The use of whole blood or plasma has not been established. The presence of IgG antibodies in a single serum sample is not sufficient to distinguish between active and past infection. A test for IgM antibodies may be performed for patients suspected of primary infection with CMV. Performance of this assay has not been established on spectrophotometry utilizing a single wavelength. The performance characteristics have not been established for prenatal populations or newborns. The results on serum from immunosuppressed individuals must be interpreted with caution. | | Immunoassay Comparison | | | | Feature | Elecsys CMV IgG Reagent and Calibrator (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 and Calibrator (Candidate Device) | Diamedix Is-CMV IgG (Predicate Device: K981163) | | Labeled Performance Characteristics |…

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

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ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

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Device Story

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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