(270 days)
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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
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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
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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.
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
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 | ||
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: 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 | ||
Limitations, | ||
continued | In 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. |
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
Comparison of Assays—Similarities and Differences, continued
10
Comparison of Assays—Similarities and Differences, continued
Continued on next page
11
and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co
Comparison of Assays—Similarities and Differences, continued
Continued on next page
12
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 | ||
Percent | ||
Agreement/ | ||
Relative | ||
Sensitivities and | ||
Specificities | 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 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: