(197 days)
Not Found
No
The description focuses on a standard immunoassay technology (ECLIA) and its performance characteristics. There is no mention of AI, ML, or any computational methods that would suggest their use in the device's operation or interpretation of results beyond standard calibration and thresholding.
No.
Explanation: The device is an in vitro diagnostic test intended to detect IgG antibodies to CMV, aiding in the determination of serological status. It does not provide any treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Elecsys CMV IgG assay is "an in vitro qualitative test for the detection of IgG antibodies to CMV" and is "intended as an aid in the determination of the serological status to CMV". This indicates that the device is used to help diagnose or determine the presence of a specific condition (CMV infection status) by detecting biomarkers (IgG antibodies).
No
The device is an in vitro diagnostic (IVD) assay that uses reagents, calibrators, and is intended for use on a specific hardware analyzer (cobas e immunoassay analyzers). It involves physical components and chemical reactions, not solely 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 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 term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay ("electrochemiluminescence immunoassay 'ECLIA'") that analyzes biological samples (serum and plasma) to detect a specific analyte (CMV IgG antibodies). This is characteristic of an IVD.
- Performance Studies: The performance studies described (Precision, Biotin Interference, Method Comparison) are typical evaluations performed on IVD devices to demonstrate their analytical performance and equivalence to predicate devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K131605) indicates that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for new IVDs.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Elecsys CMV IgG assay is an in vitro qualitative test for the detection of IgG antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the determination of the serological status to CMV in individuals in which a CMV IgG test was ordered, including pregnant women.
Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This test is not intended for use in screening blood and plasma donors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
LFZ
Device Description
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.
Elecsys PreciControl CMV lgG contains liquid control 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 lgG assay kit, while the associated is packaged separately.
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. This test is not intended for use in neonatal screening.
Intended User / Care Setting
Not Found. This test is not intended for use at point of care facilities.
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)
- Precision: The precision of the Elecsys CMV IgG assay was evaluated on one cobas e 801 immunoassay analyzer with one reagent lot. The protocol consisted of testing 2 aliquots of each of three levels of controls and 5 human serum samples per run, 2 runs per day for 21 days. The samples were run in randomized order on the analyzer. Repeatability and Intermediate imprecision were calculated according to CLSI EP05-A3 including the 95% confidence interval.
- Biotin Interference: The effect on quantitation of analyte in the presence of biotin using the updated Elecsys CMV IgG assay was determined using three serum samples (negative, positive close to cut-off, positive) according to CLSI EP07-A3 Appendix A. Native human serum pools were used for the low and mid concentration samples. The high human serum sample comprises a single serum donor. Samples were divided, and one part of each sample was spiked with the interfering endogenous substance and used as the "interference pool." Another part of the same volume of solvent as the interfering endogenous substance (without interfering substance) and used as the related "dilution pool." A series of 11 dilution steps were prepared by mixing the interference pools and the related dilution pools. The mean recovery (absolute deviation or percent recovery) was calculated for each sample compared to the expected value. The maximum value with no interference observed was 2400 ng/mL. The method sheet will be set to 1200 ng/mL.
- Method Comparison to Predicate: A method comparison study was performed to demonstrate equivalency between the current Elecsys CMV IgG assay and the biotin-updated Elecsys CMV IgG assay on one cobas e 801 analyzer. A total of 280 samples were measured with one reagent lot of the current Elecsys CMV IgG assay and three different reagent lots of the biotin-updated Elecsys CMV IgG assay in single determination on the cobas e 801 analyzer. Results are presented in a 3x3 table. Positive Agreement and Negative Agreement between the current and updated assay were calculated. The resulting data support the equivalence of the current non-biotin and biotin-updated assay.
- Stability: The stability studies and acceptance criteria have been reviewed and found to be acceptable. The stability data supports Roche Diagnostic's claims as reported in the package labeling.
All performance specifications were met. The information provided in this 510(k) Premarket Notification is complete and supports a substantial equivalence decision. The analytical studies demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device with improved biotin tolerance level up to 1200 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
October 12, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Roche Diagnostics Bin Sun Regulatory Affairs Program Manager 9115 Hague Road Indianapolis, Indiana 46250
Re: K220911
Trade/Device Name: Elecsys CMV IgG Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus Serological Reagents Regulatory Class: Class II Product Code: LFZ Dated: March 28, 2022 Received: March 29, 2022
Dear Bin Sun:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maria Garcia, Ph.D. Assistant Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Elecsys CMV IgG (09118551190)
Indications for Use (Describe)
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 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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3
510(k) Summary
Prepared on: 2022-03-28
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Roche Diagnostics |
|---|---|
| Applicant Address | 9115 Hague Road Indianapolis IN 46250 United States |
| Applicant Contact Telephone | 317-292-3781 |
| Applicant Contact | Mr. Bin Sun |
| Applicant Contact Email | bin.sun.bs2@roche.com |
21 CFR 807.92(a)(2)
| Device Trade Name | Elecsys CMV IgG (09118551190) |
|---|---|
| Common Name | Cytomegalovirus serological reagents |
| Classification Name | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Regulation Number | 866.3175 |
| Product Code | LFZ |
21 CFR 807.92(a)(3)
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K131605 | Elecsys CMV IgG Immunoassay | LFZ |
21 CFR 807.92(a)(4)
Device Description SummaryElecsys 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.
Elecsys PreciControl CMV lgG contains liquid control 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 lgG assay kit, while the associated is packaged separately.
Intended Use/Indications for Use
The Elecsys CMV IgG assay is an in vitro qualitative test for the detection of IgG antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the determination of the serological status to CMV in individuals in which a CMV IqG test was ordered, including pregnant women.
Performance characteristics have not been evaluated in 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.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
4
Elecsys CMV IgG (updated assay, Mat. No. 09118551190) is substantially equivalent to Elecsys CMV IgG, cleared under K131605.
The intended use of Elecsys CMV IgG was updated to remove analyzers that are no longer supported for use with Roche assays. The indications for use of updated Elecsys CMV IgG assay did not change from the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
Roche Diagnostics has updated the current Elecsys CMV IgG assay in order to improve the biotin tolerance from ≤ 100 ng/mL to ≤ 1200 ng/mL and to reduce streptavidin interference. A technical solution was implemented by adding an of the reagents, which allows depletion of bioting free bioting free bioting a streptavidin interference reducing agent to enhance the streptavidin tolerance. No other technological characteristics were changed. The information submitted in this Premarket Notification supports a substantial equivalent decision.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
1. Precision
The precision of the Elecsys CMV IgG assay was evaluated on one cobas e 801 immunoassay analyzer with one reagent lot. The protocol consisted of testing 2 aliquots of each of three levels of controls and 5 human serum samples per run, 2 runs per day for 21 days. The samples were run in randomized order on the analyzer. Repeatability and Intermediate imprecision were calculated according to CLSI EP05-A3 including the 95% confidence interval.
2. Biotin Interference
The effect on quantitation of analyte in the presence of biotin using the updated Elecsys CMV IgG assay was determined using three serum samples (negative, positive close to cut-off, positive) according to CLSI EP07-A3 Appendix A.
Native human serum pools were used for the low and mid concentration samples. The high human serum sample comprises a single serum donor. Samples were divided, and one part of each sample was spiked with the interfering endogenous substance and used as the "interference pool." Another part of the same volume of solvent as the interfering endogenous substance (without interfering substance) and used as the related "dilution pool."
A series of 11 dilution steps were prepared by mixing the interference pools and the related dilution pools.
The mean recovery (absolute deviation or percent recovery) was calculated for each sample compared to the expected value. The maximum value with no interference observed was 2400 ng/mL. The method sheet will be set to 1200 ng/mL.
3. Method Comparison to Predicate
A method comparison study was performed to demonstrate equivalency between the current Elecsys CMV IgG assay and the biotin-updated Elecsys CMV IgG assay on one cobas e 801 analyzer.
A total of 280 samples were measured with one reagent lot of the current Elecsys CMV IgG assay and three different reagent lots of the biotin-updated Elecsys CMV IgG assay in single determination on the cobas e 801 analyzer. Results are presented in a 3x3 table. Positive Agreement and Negative Agreement between the current and updated assay were calculated. The resulting data support the equivalence of the current non-biotin and biotin-updated assay.
4. Stability
The stability studies and acceptance criteria have been reviewed and found to be acceptable. The stability data supports Roche Diagnostic's claims as reported in the package labeling.
All performance specifications were met. The infornation provided in this 510(k) Premarket Notification is complete and supports a substantial equivalence decision. The analytical studies demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device with improved biotin tolerance level up to 1200 ng/mL.