(88 days)
No
The summary describes a standard immunoassay and automated analyzer system. There is no mention of AI, ML, or any related technologies in the device description, performance studies, or key metrics. The focus is on the analytical performance of the immunoassay and the functionality of the automated analyzer.
No.
This device is an immunoassay intended to aid in the diagnosis of CMV infection by detecting antibodies, not to directly treat or prevent a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the test is "intended as an aid in the diagnosis of recent or current CMV infection."
No
The device is an immunoassay kit (reagents) intended for use on a specific hardware analyzer (cobas e immunoassay analyzers). While the analyzer is software-controlled, the device itself is a physical diagnostic test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro qualitative detection of IgM 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.
- Purpose: The test is intended as an "aid in the diagnosis of recent or current CMV infection," which is a diagnostic purpose performed outside of the living body.
- Sample Type: The test uses human body fluids (serum and plasma), which are typical samples for in vitro diagnostic tests.
- Device Description: The "Device Description" further clarifies that it's an "in vitro determination of analytes in human body fluids."
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro qualitative detection of IgM 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 diagnosis of recent or current CMV infection in individuals for which a CMV IgM 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 cobas e immunoassay analyzers.
Product codes
LFZ, JJE
Device Description
Elecsys CMV IgM is a qualitative assay for the detection of IgM antibodies to CMV in human serum and plasma for use on the cobas e 801 immunoassay analyzer. The cobas e 801 immunoassay analyzer is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series cleared under K100853. It uses electrochemiluminescent technology for signal generation and measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Repeatability and Intermediate Precision:
The following precision results were obtained with the Elecsys CMV IgM assay on the cobas e 801 with serum samples. Within run precision (repeatability) and intermediate precision were determined according to CLSI Guideline EP05-A3. All results met predefined acceptance criteria.
- Sample HSP 1: Mean 0.202, Repeatability SD 0.002 (CV 1.2%), Intermediate precision SD 0.006 (CV 2.8%), n 84
- Sample HSP 2: Mean 0.847, Repeatability SD 0.011 (CV 1.3%), Intermediate precision SD 0.015 (CV 1.8%), n 84
- Sample HSP 3: Mean 1.09, Repeatability SD 0.018 (CV 1.6%), Intermediate precision SD 0.020 (CV 1.8%), n 84
- Sample HSP 4: Mean 3.46, Repeatability SD 0.033 (CV 1.0%), Intermediate precision SD 0.049 (CV 1.4%), n 84
- Sample HSP 5: Mean 1.28, Repeatability SD 0.013 (CV 1.0%), Intermediate precision SD 0.023 (CV 1.8%), n 84
- Sample PC CMV IgM 1: Mean 0.225, Repeatability SD 0.002 (CV 0.9%), Intermediate precision SD 0.006 (CV 2.6%), n 84
- Sample PC CMV IgM 2: Mean 1.85, Repeatability SD 0.036 (CV 1.9%), Intermediate precision SD 0.041 (CV 2.2%), n 84
Analytical Sensitivity: Limit of Blank (LoB) and Limit of Detection (LoD):
Determined according to CLSI EP17-A2 on the cobas e 801. LoB = 0.243 COI, LoD = 0.276 COI. LoQ not performed as it is unnecessary for qualitative assay.
High Dose Hook Effect:
Testing with Elecsys CMV IgM assay on the cobas e 801 analyzer using serum samples with high CMV IgM concentrations using a dilution series. All results met predefined acceptance criteria demonstrating no high dose hook effect.
Endogenous and Drug Interferences:
The effect on recovery of analyte with the Elecsys CMV IgM assay on the cobas e 801 in the presence of potentially interfering endogenous substances (hemoglobin, lipemia, bilirubin, biotin and rheumatoid factor) was evaluated. All results met the pre-defined acceptance criteria demonstrating no interference from:
- Hemoglobin up to 500 mg/dL
- Intralipid up to 1500 mg/dL
- Bilirubin up to 20 mg/dL
- Biotin up to 100 ng/mL
- Rheumatoid factor up to 899 IU/mL
Exogenous Interferences - Anticoagulants:
The effect on recovery of analyte with the Elecsys CMV IgM assay in the presence of anticoagulants was determined on the cobas e 801. All results met the pre-defined acceptance criteria, demonstrating that serum, lithium-heparin plasma, K2-EDTA plasma and K3-EDTA plasma and serum collected in tubes containing separating gel are acceptable sample types.
Exogenous Interferences - Drugs:
18 commonly used drugs and two special drugs (Ganciclovir and Valganciclovir) were evaluated for interference. All results met the pre-defined acceptance criteria, demonstrating no interference.
Method Comparison Between Analyzer Platforms:
Equivalence of the Elecsys CMV IgM assay on the cobas e 801 and the cobas e 601 was evaluated by a method comparison study. Plasma samples were measured on both analyzers. Positive and negative agreement of the results between the two platforms were calculated and demonstrated equivalence.
- Negative Percent Agreement (NPA) = 100% (142/142)
- Positive Percent Agreement (PPA) = 100% (73/73)
- Agreement rate for Indeterminate was 75% (6/8)
Assay Cut-Off:
Cutoff established with in-house studies and validated by external clinical studies on the Elecsys 2010. The same cutoff is applied to the cobas e 801 due to family of instruments.
- Sample results
§ 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).
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
March 17. 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
Roche Diagnostics Angelo Pereira Regulatory Affairs Senior Program Manager 9115 Hague Road Indiananolis, IN 46250
Re: K163569
Trade/Device Name: Elecsys CMV IgM Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: Class II Product Code: LFZ, JJE Dated: December 16, 2016 Received: December 19, 2016
Dear Mr. Pereira:
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 Part 801 and Part 809; medical device reporting (reporting of
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Sincerely.
Steven R. Gitterman -S
for Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163569
Device Name Elecsys CMV IgM
Indications for Use (Describe)
Immunoassay for the in vitro qualitative detection of IgM 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 diagnosis of recent or current CMV infection in individuals for which a CMV IgM 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 cobas e immunoassay analyzers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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- Elecsys CMV IgM on the cobas e 801 analyzer
510(k) Summary
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0416 | |
| Contact | Angelo Pereira |
| Phone: (317) 521-3544 | |
| FAX: (317) 521-2324 | |
| Email: angelo.pereira@roche.com | |
| Date Prepared | March 09, 2017 |
| Proprietary Name | Elecsys CMV IgM |
| cobas e 801 Immunoassay analyzer | |
| Common Name | CMV IgM assay |
| Immunoassay analyzer | |
| Classifications | 21CFR866.3175, Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Class II | |
| 21CFR862.2160, Chemistry analyzer; Class I | |
| Product Codes | LFZ |
| JJE | |
| Predicate Devices | Elecsys CMV IgM on the cobas e 601 (K142133) |
| Establishment Registration | The establishment registration number for Roche Diagnostics GmbH in |
| Mannheim, Germany is 9610126, and for Penzberg, Germany, 9610529. The | |
| establishment registration number for Roche Diagnostics in the United States is | |
| 1823260 |
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DEVICE DESCRIPTION 1.
Elecsys CMV IgM is a qualitative assay for the detection of IgM antibodies to CMV in human serum and plasma for use on the cobas e 801 immunoassay analyzer. The cobas e 801 immunoassay analyzer is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series cleared under K100853. It uses electrochemiluminescent technology for signal generation and measurement.
2. INTENDED USE
Elecsys CMV IgM immunoassay is intended for the in vitro qualitative detection of IgM 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 diagnosis of recent or current CMV infection in individuals for which a CMV IgM 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 the cobas e immunoassay analyzers
3. DEVICE TO WHICH EQUIVALENCE IS CLAIMED
Elecsys CMV IgM on the cobas e 601 is used as the predicate assay for the Elecsys CMV IzM on the cobas e 801 (new device). The cobas e 801 analyzer module is a modified version of the predicate device, the cobas e 601 analyzer module, part of the cobas 6000 modular analyzer cleared under K060373.
Comparative properties for the Elecsys CMV IgM assay run on the cobas e 801 and the cobas e 601 is provided in the table below.
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Table 1: Similarities and Differences for the Elecsys CMV IgM assay on cobas e 801 versus cobas e 601
| Feature | Predicate Device: Elecsys CMV IgM on
cobas e601 analyzer module
(K142133) | Candidate Device: Elecsys CMV IgM on
cobas e801 analyzer module |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys CMV IgM immunoassay is intended
for the in vitro qualitative detection of IgM
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 diagnosis of recent or current CMV
infection in individuals for which a CMV IgM
test was ordered, including pregnant women. | Same |
| Instrument Platform | Elecsys immunoassay analyzer, part of the
cobas 6000 modular analyzer series (K060373) | Elecsys immunoassay analyzer, part of the
cobas 8000 modular analyzer series
(K100853) |
| Assay Protocol | μ- Capture | Same |
| Measurement principle | Electrochemiluminescence immunoassay
(ECLIA) method | Same |
| Antibody/ Reagents | Biotinylated monoclonal anti-h-IgM antibody
(mouse)
CMV-specific antigen (recombinant, E. coli)
labeled with ruthenium complex
Streptavidin -coated microparticles | Same |
| Sample size | 10 µL of sample | 6 µL of sample |
| Sample Types | Serum, serum with separating gel, Li-heparin,
K2EDTA and K3EDTA | Serum, serum with separating gel, Li-
heparin, K2EDTA, K3EDTA. |
| Basic Features of the Instruments | | |
| Measurement principle | Electrochemiluminescence immunoassay
method (ECLIA) | Same |
| Workflow principle | Batch or random access | Same |
| Throughput | 170 tests/hour/module | 300 tests/hour/module |
| Sample Handling | | |
| Typical sample volumes | 10-50μL | 4-60 µL |
| Sample types | Serum, plasma, urine, CSF | Same |
| Sample handling system | Input and transport of samples using universal
sample racks, core/transportation unit and
STAT port | Input and transport of samples using universal
sample racks, modular sample buffer input,
core/transportation unit and STAT port. |
| Sample
capacity on board | 150 | 300 |
| Sample identification | Barcode | Same |
| Reagent Handling | | |
| Feature | Predicate Device: Elecsys CMV IgM on
cobas e601 analyzer module
( K142133) | Candidate Device: Elecsys CMV IgM on
cobas e801 analyzer module |
| Reagent volume | 10-190 μL | 6-60 μL |
| Onboard
storage temperature | 18-22°C | 5-10°C |
| Reagent bottle/Cassette
identification | Barcode | RFID |
| Application information
transfer to instrument | Via barcode on reagent pack and electronic
transfer via cobas link | Electronic transfer via cobas link |
| | Test Reaction Chamber | |
| Temp. control | Incubation at 37°C. | Same |
| | Detection | |
| Measuring unit | 2 | Same |
| Detection unit | ECL unit with sipper, measuring cell and
photomultiplier | Design of the sipper changed to shorten the
detection cycle time; measuring cell and
photomultiplier are the same |
| Detection time | 1.2 seconds | Same |
| Detection cycle time | 42 sec | 24 sec |
| | Software | |
| Software | cobas 6000 modular
System Software | cobas 8000 modular
System Software |
| Configuration | One PC and one core in combination with
several e-modules or c analytical modules | Same |
| Functions performed | Data input, sample processing, result
calculation, result reporting, quality control | Same |
| Analytical Unit(s)
functions | Control of analytic processes (pipetting,
incubation, detection) and Primary Signal
processing | Same |
| Result calculation | Automated measuring of ECL signal and
automated calculation of concentrations via
calibration curve | Same |
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PERFORMANCE CHARACTERISTICS 4.
4.1. Repeatability and Intermediate Precision
The following precision results were obtained with the Elecsys CMV IgM assay on the cobas e 801 with serum samples. Within run precision (repeatability) and intermediate precision were
7
determined according to CLSI Guideline EP05-A3. All results met predefined acceptance criteria.
| Repeatability | Intermediate precision | |||||
|---|---|---|---|---|---|---|
| Sample | Mean | |||||
| [COI] | SD | |||||
| [COI] | CV | |||||
| [%] | SD | |||||
| [COI] | CV | |||||
| [%] | n | |||||
| HSP 1 | 0.202 | 0.002 | 1.2 | 0.006 | 2.8 | 84 |
| HSP 2 | 0.847 | 0.011 | 1.3 | 0.015 | 1.8 | 84 |
| HSP 3 | 1.09 | 0.018 | 1.6 | 0.020 | 1.8 | 84 |
| HSP 4 | 3.46 | 0.033 | 1.0 | 0.049 | 1.4 | 84 |
| HSP 5 | 1.28 | 0.013 | 1.0 | 0.023 | 1.8 | 84 |
| PC CMV IgM 1 | 0.225 | 0.002 | 0.9 | 0.006 | 2.6 | 84 |
| PC CMV IgM 2 | 1.85 | 0.036 | 1.9 | 0.041 | 2.2 | 84 |
Table 1: Summary of Precision Results for Elecsys CMV IgM
4.2. Analytical Sensitivity: Limit of Blank (LoB) and Limit of Detection (LoD)
The Limit of Blank (LoB) and Limit of Detection (LoD) of the Elecsys CMV IgM assay were determined according to CLSI EP17-A2 on the cobas e 801.
Table 2: LoB and LoD for Elecsys CMV IgM
| LoB (COI) | LoD (COI) |
|---|---|
| 0.243 | 0.276 |
Given that the Elecsys CMV IgM assay is qualitative and its LoD of 0.276 COI is well below the cut-off value of 0.7 COI, determination of a Limit of Quantiation (LoQ) is unnecessary. As such determination of the LoQ was not performed.
4.3. High Dose Hook Effect
Testing with the Elecsys CMV IgM assay was assessed on the cobas e 801 analyzer using serum samples with high CMV IgM concentrations using a dilution series. All results met the predefined acceptance criteria demonstrating no high dose hook effect for the Elecsys CMV IgM assay.
8
Endogenous and Druq Interferences 4.4.
The effect on recovery of analyte with the Elecsys CMV IgM assay on the cobas e 801in the presence of potentially interfering endogenous substances hemoglobin, lipemia, bilirubin, biotin and rheumatoid factor was evaluated. All results met the pre-defined acceptance criteria demonstrating no interference from:
- Hemoglobin up to500 mg/dL ●
- . Intralipid up to 1500 mg/dL
- Bilirubin up to 20 mg/dL ●
- Biotin up to 100 ng/mL
- Rheumatoid factor up to 899 IU/mL ●
4.5. Exogenous Interferences - Anticoagulants
The effect on recovery of analyte with the Elecsys CMV IgM assay in the presence of anticoagulants was determined on the cobas e 801 by comparing values obtained with samples drawn into serum, lithium-heparin plasma, K2-EDTA plasma and K3-EDTA plasma. Serum collected in tubes containing separating gel was also evaluated using the Elecsys 2010 and the E170 analyzers. All results met the pre-defined acceptance criteria, demonstrating that serum, lithium-heparin plasma. K2-EDTA plasma and K3-EDTA plasma and serum collected in tubes containing separating gel are acceptable sample types for use with the Elecsys CMV IgM assay.
Exogenous Interferences - Drugs 4.6.
In addition, 18 commonly used drugs and two special drugs Ganciclovir and Valganciclovir were evaluated for interference with the Elecsys CMV IgM assay using the Elecsys 2010 and the cobas e 411. All results met the pre-defined acceptance criteria, demonstrating no interference from the drug substances tested.
Method Comparison Between Analyzer Platforms 4.7.
The equivalence of the Elecsys CMV IgM assay on the cobas e 801 and the cobas e 601 was evaluated by a method comparison study. Plasma samples were measured on both analyzers.
9
Positive and negative agreement of the results between the two platforms were calculated and demonstrated equivalence between the analyzer platforms for the determination of IgM antibodies to CMV using the Elecsys CMV IgM assay.
Concordance Rates:
Negative Percent Agreement (NPA) = 100% (142/142)
Positive Percent Agreement (PPA) = 100% (73/73)
Agreement rate for Indeterminate was 75% (6/8)
4.8. Assay Cut-Off
The cutoff was established with in-house studies by characterizing samples using several commercially available CMV IgG and CMV IgM assays. Validation of the assay cutoff was performed by external clinical studies on the Elecsys 2010 . Since the Elecsys 2010 and the cobas e 801 are members of the same Elecsys family of instruments, the same cutoff has been applied to the cobas e 801 analyzer. Classification of samples based on the establishment, verification and validation is as follows:
Sample results