(86 days)
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No
The device description details a standard immunoassay process with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies focus on agreement with a predicate device and standard precision metrics.
No
This device is an in vitro diagnostic (IVD) tool designed to detect antibodies for diagnostic purposes (aids in the diagnosis of CMV infection), not to treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use" and serves "as an aid in the diagnosis of current and recent CMV infection."
No
The device description details a solid-phase, enzyme labeled chemiluminescent immunoassay with physical reagents (beads, antibodies, enzymes) and a process involving incubation, washing, and signal generation, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "IMMULITE® 2000 CMV IgM is for in vitro diagnostic use with IMMULITE® 2000 Systems analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma..."
This statement clearly identifies the device as being used outside of the body (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
IMMULITE® 2000 CMV IgM is for in vitro diagnostic use with IMMULITE® 2000 Systems analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities.
Performance characteristics for this assay have not been established in immunocompromised, immunosuppressed or organ transplant individuals.
CMV IgM Controls are assayed, bi-level controls intended for use with the IMMULITE 2000 CMV IgM assay. They are intended as an aid in monitoring day-today assay performance.
Product codes
LKQ, JIT, JJX
Device Description
IMMULITE 2000 CMV IgM is a solid-phase, enzyme labeled chemiluminescent three-step immunoassay. The solid phase (bead) is coated with inactivated, purified CMV antigen (strain AD-169 from infected cell lysates). The liquid phase consists of two reagents: 1) polyclonal goat anti-human IgG antibody in buffer, and 2) alkaline phosphatase (bovine calf intestine) conjugated to polyclonal goat anti-human IgM antibody in buffer.
In the first cycle, the patient sample and polyclonal goat anti-human IgG antibody are incubated together without the bead for 30 minutes. During this time, anti-IgG antibodies block IgG present in the patient's sample.
In the second cycle, the pretreated sample and polyclonal goat anti-human IgG antibody are transferred to the second reaction tube. Anti-IgG antibodies block the remaining IgG from the patient's sample from binding to the CMV antigen on the bead. During this time, CMV IgM in the patient sample binds to CMV antigen on the bead. Unbound sample and reagent are then removed by centrifugal washes.
In the third cycle, the enzyme conjugated polyclonal goat anti-human IgM antibody is added to the second reaction tube. The enzyme conjugate binds to immobilized IgM to form the antibody sandwich complex. The unbound enzyme conjugate is removed by centrifugal washes. Finally, chemiluminescent substrate is added to the reaction tube and the signal is generated in proportion to the bound enzyme.
Mentions image processing
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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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
As part of the clinical study, samples from various patient populations were tested with both the IMMULITE® 2000 CMV IgM assay and the VIDAS® CMV IgM assay. A total of 636 serum samples were collected at four U.S. sites and three commercial suppliers and were tested at three U.S. sites. There were 109 retrospective samples tested where the CMV IgM + status was known. The remaining 527 samples from target enrollment groups were collected prospectively. Each sample was tested with the IMMULITE 2000 CMV IgM assay and with a commercially available CMV IgM assay (Kit A).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison for Prospective Subjects:
A total of 527 prospective samples were tested.
IMMULITE 2000 CMV IgM vs Kit A:
Positive Agreement: 47.1% (8/17, 95% CI: 23.0% - 72.2%)
Negative Agreement: 97.2 % (495/509, 95% CI: 95.4% - 98.5%)
Comparison for Retrospective Subjects:
A total of 109 retrospective samples were tested.
IMMULITE 2000 CMV IgM vs Kit A:
Positive Agreement: 97.8% (90/92, 95% CI: 92.4% - 99.7%)
Negative Agreement: 56.3% (9/16, 95% CI: 29.9% - 80.2%)
Precision information:
The precision of the IMMULITE 2000 CMV assay as measured by total CV ranged from 5.1% to 21.4% for the 8 samples tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement for Prospective Subjects: 47.1% (8/17, 95% CI: 23.0% - 72.2%)
Negative Agreement for Prospective Subjects: 97.2 % (495/509, 95% CI: 95.4% - 98.5%)
Positive Agreement for Retrospective Subjects: 97.8% (90/92, 95% CI: 92.4% - 99.7%)
Negative Agreement for Retrospective Subjects: 56.3% (9/16, 95% CI: 29.9% - 80.2%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary as Required by 21 CFR 807.92
| Submitter: | Siemens Healthcare Diagnostics Inc.
5210 Pacific Concourse Drive
Los Angeles, CA 90045-6900 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Robert C. Eusebio
Director Regulatory Affairs
1584 Enterprise Blvd
West Sacramento, CA 95691
(916) 374-3183 |
| Date Prepared: | May 10, 2010 |
| Device Trade Name: | IMMULITE® 2000 CMV IgM |
| Common Name: | Cytomegalovirus serological reagents
21 CFR 866.3175 |
| Substantial
Equivalence: | K933549
VIDAS® CMV IgM assay |
| Device Description: | IMMULITE 2000 CMV IgM is a solid-phase, enzyme
labeled chemiluminescent three-step immunoassay. The
solid phase (bead) is coated with inactivated, purified
CMV antigen (strain AD-169 from infected cell lysates).
The liquid phase consists of two reagents: 1) polyclonal
goat anti-human IgG antibody in buffer, and 2) alkaline
phosphatase (bovine calf intestine) conjugated to
polyclonal goat anti-human IgM antibody in buffer. |
MAY 13 2010
In the first cycle, the patient sample and polyclonal goat
anti-human IgG antibody are incubated together without
the bead for 30 minutes. During this time, anti-IgG
antibodies block IgG present in the patient's sample.
In the second cycle, the pretreated sample and polyclonal
goat anti-human IgG antibody are transferred to the second
reaction tube. Anti-IgG antibodies block the remaining IgG
from the patient's sample from binding to the CMV
antigen on the bead. During this time, CMV IgM in the
patient sample binds to CMV antigen on the bead.
Unbound sample and reagent are then removed by
centrifugal washes.
In the third cycle, the enzyme conjugated polyclonal goat
1
| anti-human IgM antibody is added to the second reaction tube. The enzyme conjugate binds to immobilized IgM to form the antibody sandwich complex. The unbound enzyme conjugate is removed by centrifugal washes. Finally, chemiluminescent substrate is added to the reaction tube and the signal is generated in proportion to the bound enzyme. | |
|---|---|
| Intended Use: | IMMULITE® 2000 CMV IgM is for in vitro diagnostic use with IMMULITE® 2000 Systems analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities. |
| Performance characteristics for this assay have not been established in immunocompromised, immunosuppressed or organ transplant individuals. | |
| Technological Aspects: | A comparison of the device features, intended use, laboratory data and other information demonstrate that the IMMULITE® 2000 CMV IgM assay is substantially equivalent to the currently marketed bioMerieux Vitek VIDAS CMV IgM assay, as summarized in the following tables. |
and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the fir
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2
| IMMULITE 2000 | VIDAS | |
|---|---|---|
| Intended Use | For in vitro diagnostic use with | |
| IMMULITE® 2000 Systems | ||
| analyzers — for the qualitative | ||
| detection of IgM antibodies to | ||
| cytomegalovirus (CMV) in | ||
| human serum or plasma | ||
| (EDTA or heparinized), as an | ||
| aid in the diagnosis of current | ||
| and recent CMV infection in | ||
| individuals with signs and | ||
| symptoms of CMV infection or | ||
| clinical suspicion of CMV | ||
| infection. This assay is not | ||
| FDA cleared or approved for | ||
| use in testing (screening) | ||
| blood or plasma donors, | ||
| neonatal screening, or for use | ||
| at point-of-care facilities. | ||
| Performance characteristics | ||
| for this assay have not been | ||
| established in | ||
| immunocompromised, | ||
| immunosuppressed or organ | ||
| transplant individuals. | For in vitro diagnostic use | |
| with a VIDAS instrument as | ||
| an automated enzyme-linked | ||
| fluorescent immunoassay | ||
| (ELFA) for the qualitative | ||
| detection of anti-CMV IgM | ||
| antibodies in human serum. It | ||
| is intended to be used as an | ||
| aid in the diagnosis of | ||
| cytomegalovirus infection. It | ||
| is not intended for use in | ||
| testing (screening) blood or | ||
| plasma donors. | ||
| Assay Type | Chemiluminescent enzyme | |
| IgM antibody μ-capture | ||
| immunoassay | Enzyme-linked fluorescent | |
| immunoassay (ELFA) | ||
| Capture/Detection | ||
| Antigen/Antibody | The solid phase is a bead | |
| coated with inactivated, | ||
| purified CMV antigen (strain | ||
| AD-169 from infected cell | ||
| lysates). The conjugate is | ||
| polyclonal goat anti-human | ||
| IgM antibody conjugated to | ||
| alkaline phosphatase. | The Solid Phase Receptacle is | |
| coated with CMV antigen | ||
| (strain AD169). The | ||
| conjugate is comprised of | ||
| mouse monoclonal anti- | ||
| human IgM antibodies | ||
| conjugated to alkaline | ||
| phosphatase. | ||
| Type of Assay | Qualitative Assay | Qualitative Assay |
| IMMULITE 2000 | VIDAS | |
| Cut-Offs | Test value = ratio of signal | |
| from sample to that of signal | ||
| of adjustor curve parameter | ||
| P1. | Test Value Threshold = ratio | |
| of signal from sample to set of | ||
| thresholds stored in the | ||
| computer | ||
| ≥1.1 Reactive | ≥0.90 Positive | |
| 0.9 to |