K Number
K131605
Device Name
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
Manufacturer
Date Cleared
2014-02-28

(270 days)

Product Code
Regulation Number
866.3175
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The summary describes a standard immunoassay technology and does not mention any AI or ML components in the device description, intended use, or performance studies.

No.
This device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of CMV infection by detecting antibodies, not to treat or directly manage a condition in a patient.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the test is "intended for adults, including expectant mothers, as an aid in presumptive diagnosis of CMV infection." This directly indicates its role in diagnosis.

No

The device is an immunoassay kit (reagents, calibrators, and controls) intended for use on specific immunoassay analyzers, which are hardware devices. The description details the chemical process and components of the assay, not just software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that 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 phrase "in vitro" is a key indicator of an IVD.
  • Sample Type: The test is performed on human biological samples (serum and plasma).
  • Purpose: The test is used as an "aid in presumptive diagnosis of CMV infection" and to "indicate past infection with CMV." This is a diagnostic purpose.
  • Device Description: The description details a laboratory-based immunoassay system that analyzes biological samples.
  • Quality Control: The inclusion of Elecsys PreciControl CMV IgG for quality control of the immunoassay further supports its use in a laboratory setting for diagnostic testing.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.

N/A

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.

Product codes (comma separated list FDA assigned to the subject device)

LFZ, JJX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

Adults, including expectant mothers. Not established for pediatric population, neonates.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

(1) The Elecsys CMV IgG Immunoassay was evaluated for several performance characteristics, including precision, LoB and LoD, high dose hook effect, cross reactivity, method comparison between analyzer platforms, interfering substances, and reagent, calibration, and sample stability.
(2) The Elecsys PreciControl HSV was evaluated for value assignment and stability.
Additionally, the Elecsy CMV IgG assay was evaluated in a clinical trial using an adult cohort that included specimens from pregnant subjects and CMV IgM-positive subjects.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K981163, K072617

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

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 | |

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510(k) Summary, Continued

Confidential

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510(k) Summary, Continued

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510(k) Summary, Continued

Comparison of Assays—Similarities and Differences
Immunoassay Comparison
FeatureElecsys HSV-2 IgG Reagent and
Calibrator
(Candidate Device)Is-CMV IgG Test System
(Predicate Device: K981163)
General Assay Features
Intended
Use/
Indications
for UseThe 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
ProtocolSandwich assaySolid phase microtiter
Detection
ProtocolElectrochemiluminescent
ImmunoassayEnzyme-linked immunosorbent assay
Applications18 minutesN/A

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| Comparison of Assays—Similarities and Differences

Immunoassay Comparison
FeatureElecsys CMV IgG Reagent and
Calibrator
(Candidate Device)Diamedix Is-CMV IgG
(Predicate Device: K981163)
General Assay Features
Instrument
PlatformElecsys 2010, MODULAR
ANALYTICS E170, cobas e 411,
cobas e 601, and cobas e 602Automated EIA Processor or Manual
Sample
Volume20 μL100 μL after dilution
Sample
TypeHuman serum and Lithium-heparin,
K2-EDTA, and K3-EDTA plasmaHuman whole blood and serum
ReagentsReagents 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.
CalibratorIncluded with the reagent kitIncluded in the reagent kit as
Diamedix CMV IgG Standards
Calibration
IntervalCalibration 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.

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Comparison of Assays-Similarities and Differences, continued
Immunoassay Comparison
FeatureElecsys CMV IgG Reagent and
Calibrator
(Candidate Device)Diamedix Is-CMV IgG
(Predicate Device: K981163)
General Assay Features
ControlsElecsys PreciControl CMV IgGHigh positive, low positive, and
negative controls included in the
reagent kit
Traceability /
StandardizationThe 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
StabilityReagents (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
FeatureElecsys CMV IgG Reagent and
Calibrator
(Candidate Device)Diamedix Is-CMV IgG
(Predicate Device: K981163)
General assay features
Result
InterpretationResults obtained with the Elecyss
CMV IgG assay can be interpreted
as follows:
Non-reactive: 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
FeatureElecsys CMV IgG Reagent and
Calibrator
(Candidate Device)Diamedix Is-CMV IgG
(Predicate Device: K981163)
Labeled Performance Characteristics
Limitations,
continuedIn vitro tests were performed on
18 commonly used
pharmaceuticals and in addition
on ganciclovir and valganciclovir.
No interference with the assay
was found. In rare cases, interference due to
extremely high titers of antibodies
to immunological components,
streptavidin or ruthenium can
occur. These effects are
minimized by suitable test design. For diagnostic purposes, the
results should always be assessed
in conjunction with the patient's
medical history, clinical
examination and other findings.

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Comparison of Assays—Similarities and Differences, continued

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Comparison of Assays—Similarities and Differences, continued

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Comparison of Assays—Similarities and Differences, continued

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Comparison of Assays-Similarities and Differences, continued

Immunoassay Comparison
FeatureElecsys CMV IgG Reagent and
Calibrator
(Candidate Device)Diamedix Is-CMV IgG
(Predicate Device: K981163)
Labeled Performance Characteristics
Percent
Agreement/
Relative
Sensitivities and
SpecificitiesRoutine 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 EIA
Manual (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 EIA
Automated (95% CI)
Site 3 (n=201): 100.0% (97.6-100.0%)

Relative Specificities to EIA
Manual (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 EIA
Automated (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 the
quality control of the Elecsys CMV IgG
immunoassay on the Elecsys and cobas e
immunoassay analyzers. | Elecsys PreciControl Rubella IgG is
used for quality control of the Elecsys
Rubella IgG immunoassay on the
Elecsys and cobas e immunoassay
analyzers. |
| Levels | Three | Two |
| Format | Liquid, ready for use | Liquid, ready for use |
| Matrix | Human serum | Human serum |
| Analyte
Concentration | PreciControl 0: