(88 days)
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.
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.
The document describes the Elecsys CMV IgM assay on the cobas e 801 analyzer, which is a qualitative immunoassay for the detection of IgM antibodies to CMV. The submission (K163569) seeks to demonstrate substantial equivalence to a predicate device, the Elecsys CMV IgM on the cobas e 601 (K142133).
Here's an breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a "table of acceptance criteria" with corresponding performance values in every section, but rather states "All results met predefined acceptance criteria" for various performance characteristics. I will compile the relevant performance data points that were provided.
| Performance Characteristic | Acceptance Criteria (Implicit: "met predefined criteria") | Reported Device Performance (Elecsys CMV IgM on cobas e 801) |
|---|---|---|
| Precision | Implicit: Predefined precision limits satisfied. | Repeatability (CV)- HSP 1: 1.2%- HSP 2: 1.3%- HSP 3: 1.6%- HSP 4: 1.0%- HSP 5: 1.0%- PC CMV IgM 1: 0.9%- PC CMV IgM 2: 1.9% |
| Intermediate Precision (CV)- HSP 1: 2.8%- HSP 2: 1.8%- HSP 3: 1.8%- HSP 4: 1.4%- HSP 5: 1.8%- PC CMV IgM 1: 2.6%- PC CMV IgM 2: 2.2% | ||
| Analytical Sensitivity | Implicit: LoD below cut-off. | Limit of Blank (LoB): 0.243 COILimit of Detection (LoD): 0.276 COI (well below cut-off of 0.7 COI) |
| High Dose Hook Effect | Implicit: No high-dose hook effect observed. | "All results met the predefined acceptance criteria demonstrating no high dose hook effect for the Elecsys CMV IgM assay." |
| Endogenous Interferences | Implicit: No significant interference from tested substances. | 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) | Implicit: Acceptable sample types. | Serum, serum with separating gel, Li-heparin plasma, K2EDTA plasma, K3EDTA plasma are acceptable. |
| Exogenous Interferences (Drugs) | Implicit: No significant interference from tested drugs. | No interference from 18 common drugs, Ganciclovir, and Valganciclovir. |
| Method Comparison (Platform Equivalence) | Implicit: High positive and negative agreement. | Negative Percent Agreement (NPA): 100% (142/142)Positive Percent Agreement (PPA): 100% (73/73)Agreement rate for Indeterminate: 75% (6/8) |
2. Sample Size Used for the Test Set and Data Provenance
The document focuses on the technical performance of the device and its equivalence to a predicate. It does not clearly define a "test set" in the context of clinical cohorts but rather describes samples used for various analytical performance studies.
- Precision Study: 84 runs for repeatability and intermediate precision for each of the 7 samples (HSP 1-5, PC CMV IgM 1-2). The samples are referred to as "serum samples." Provenance is not specified (e.g., country of origin, retrospective/prospective).
- Method Comparison (Between Analyzer Platforms): 142 negative plasma samples, 73 positive plasma samples, and 8 indeterminate plasma samples. This totals 223 plasma samples. Provenance (e.g., country, retrospective/prospective) is not specified.
- Interference Studies: Number of samples not explicitly stated; typically involves spiking substances into a limited number of samples.
- Analytical Sensitivity (LoB/LoD): Number of runs/replicates used for determination is not specified, but the methodology (CLSI EP17-A2) implies a structured approach.
Data Provenance: The document generally lacks explicit details on the country of origin for the samples used in these performance studies or whether they were retrospective or prospective. It refers to "in-house studies" and "external clinical studies" for cutoff validation, but specifics are missing from this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device is an in vitro diagnostic immunoassay, not an imaging device. Therefore, the concept of "experts" (like radiologists) establishing ground truth for a "test set" in the traditional sense of image interpretation is not directly applicable.
For this type of device:
- The "ground truth" for the test samples (e.g., positive, negative, indeterminate) would typically be established by known clinical status (e.g., confirmed CMV infection or absence of infection based on various clinical and laboratory parameters, potentially using a "gold standard" or reference assay).
- The document implies that the "cutoff was established with in-house studies by characterizing samples using several commercially available CMV IgG and CMV IgM assays" and "validation of the assay cutoff was performed by external clinical studies." This suggests the ground truth (or referent status) for the samples was determined by established laboratory methods, not expert consensus on qualitative interpretation.
No specific number or qualification of "experts" is mentioned for establishing the ground truth of the performance study samples.
4. Adjudication Method for the Test Set
Since this is an immunoassay and "ground truth" is established by laboratory methods rather than subjective expert interpretation, the concept of an "adjudication method" (like 2+1 or 3+1) is not applicable here. The results are quantitative (COI values) and then categorized based on predefined cut-offs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic aids (like AI algorithms in imaging) that assist human readers. The Elecsys CMV IgM assay is a standalone laboratory diagnostic test.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the performance data presented (precision, sensitivity, interference, method comparison) represents the standalone performance of the Elecsys CMV IgM assay on the cobas e 801 analyzer. This device does not have a human-in-the-loop component for its primary diagnostic function.
7. The Type of Ground Truth Used
The ground truth used for establishing performance characteristics and assay cut-offs appears to be:
- For Method Comparison: The results from the predicate device (Elecsys CMV IgM on cobas e 601) and potentially other established/commercial CMV IgM assays. The document states "Positive and negative agreement of the results between the two platforms were calculated."
- For Assay Cut-off: "in-house studies by characterizing samples using several commercially available CMV IgG and CMV IgM assays." Additionally, "Validation of the assay cutoff was performed by external clinical studies on the Elecsys 2010." This implies a combination of reference assay results and potentially clinical outcomes/established disease status for the samples used in those studies.
It's not explicitly stated as "pathology" or "outcomes data" in this summary, but rather defined by comparison to other commercial assays and clinical studies.
8. The Sample Size for the Training Set
This document describes the validation of a commercial in vitro diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the same way. The principles for developing diagnostic assays involve extensive research and development phases where reagents, protocols, and cutoffs are refined. The "training" in this context refers to the development and optimization studies that led to the final assay characteristics.
The specific sample sizes for these development/optimization phases are not provided in this 510(k) summary, as the summary focuses on the final analytical and comparative performance data for the substantial equivalence determination.
9. How the Ground Truth for the Training Set Was Established
Again, applying the term "training set" directly to a traditional immunoassay is not precise. However, for the establishment of the assay cut-off (which is analogous to setting decision boundaries in an algorithm), the summary states:
- "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."
This indicates that the "ground truth" for determining the assay cut-offs was established through a combination of results from other established commercial CMV assays and samples from clinical studies, which would have had their CMV status determined by other means (e.g., patient history, other diagnostic tests, or clinical follow-up). The exact "how" for these broader clinical studies is referenced as being included in the predicate device's K-submission (K142133).
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Public Health Service
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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
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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 RoadP.O. Box 50416Indianapolis, IN 46250-0416 |
| Contact | Angelo PereiraPhone: (317) 521-3544FAX: (317) 521-2324Email: angelo.pereira@roche.com |
| Date Prepared | March 09, 2017 |
| Proprietary Name | Elecsys CMV IgMcobas e 801 Immunoassay analyzer |
| Common Name | CMV IgM assayImmunoassay analyzer |
| Classifications | 21CFR866.3175, Enzyme Linked Immunoabsorbent Assay, CytomegalovirusClass II21CFR862.2160, Chemistry analyzer; Class I |
| Product Codes | LFZJJE |
| Predicate Devices | Elecsys CMV IgM on the cobas e 601 (K142133) |
| Establishment Registration | The establishment registration number for Roche Diagnostics GmbH inMannheim, Germany is 9610126, and for Penzberg, Germany, 9610529. Theestablishment registration number for Roche Diagnostics in the United States is1823260 |
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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 oncobas e601 analyzer module(K142133) | Candidate Device: Elecsys CMV IgM oncobas e801 analyzer module |
|---|---|---|
| Intended Use | Elecsys CMV IgM immunoassay is intendedfor the in vitro qualitative detection of IgMantibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma and K3-EDTA plasma. The test is intended as an aidin the diagnosis of recent or current CMVinfection in individuals for which a CMV IgMtest was ordered, including pregnant women. | Same |
| Instrument Platform | Elecsys immunoassay analyzer, part of thecobas 6000 modular analyzer series (K060373) | Elecsys immunoassay analyzer, part of thecobas 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 complexStreptavidin -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 immunoassaymethod (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 universalsample racks, core/transportation unit andSTAT port | Input and transport of samples using universalsample racks, modular sample buffer input,core/transportation unit and STAT port. |
| Samplecapacity on board | 150 | 300 |
| Sample identification | Barcode | Same |
| Reagent Handling | ||
| Feature | Predicate Device: Elecsys CMV IgM oncobas e601 analyzer module( K142133) | Candidate Device: Elecsys CMV IgM oncobas e801 analyzer module |
| Reagent volume | 10-190 μL | 6-60 μL |
| Onboardstorage temperature | 18-22°C | 5-10°C |
| Reagent bottle/Cassetteidentification | Barcode | RFID |
| Application informationtransfer to instrument | Via barcode on reagent pack and electronictransfer 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 andphotomultiplier | Design of the sipper changed to shorten thedetection cycle time; measuring cell andphotomultiplier are the same |
| Detection time | 1.2 seconds | Same |
| Detection cycle time | 42 sec | 24 sec |
| Software | ||
| Software | cobas 6000 modularSystem Software | cobas 8000 modularSystem Software |
| Configuration | One PC and one core in combination withseveral e-modules or c analytical modules | Same |
| Functions performed | Data input, sample processing, resultcalculation, result reporting, quality control | Same |
| Analytical Unit(s)functions | Control of analytic processes (pipetting,incubation, detection) and Primary Signalprocessing | Same |
| Result calculation | Automated measuring of ECL signal andautomated calculation of concentrations viacalibration 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
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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.
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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.
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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 < 0.7 COI = Non-reactive sample Sample results ≥ 0.7 to < 1.0 COI = Indeterminate (Border) sample Sample results ≥ 1.0 COI = Reactive sample
4.9. Clinical Performance
Clinical performance of the Elecsys CMV IgM assay was assessed using the Elecsys 2010. This information was included in K142133. It included a multi-center clinical study, analytical specificity, verification of IgM specificity and expected values. Since the Elecsys 2010 and the cobas e 801 are members of the same Elecsys family of instruments, these clinical claims are being transferred over to the cobas e 801 analyzer.
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CONCLUSION 5.
The information provided in this Premarket Notification (510(k) will support a determination of substantial equivalence for the Elecsys CMV IgM assay on the cobas e 801 analyzer.
§ 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).